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CONVERGE - Epi/Endo Ablation For Treatment of Persistent Atrial Fibrillation(AF) (CONVERGE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01984346
Recruitment Status : Active, not recruiting
First Posted : November 14, 2013
Results First Posted : February 10, 2022
Last Update Posted : March 14, 2022
Sponsor:
Information provided by (Responsible Party):
AtriCure, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Persistent Atrial Fibrillation
Interventions Device: AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax
Device: Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering
Enrollment 170
Recruitment Details

Recruiting for the CONVERGE Study began with first site IRB approval Nov 13, 2013. Recruiting locations included physician offices, clinics and site clinical study offices.

  • The first milestone for recruiting purposes was the first 25 patients treated. This milestone was reached July 06, 2015.
  • Milestone two was hit with the attainment of 50 patients treated on September 28, 2016
  • The third milestone was the approval of the total cohort of 153 patients by the FDA on November 17, 2017.
Pre-assignment Details 10 subjects were consented but withdrew prior to assignment to a treatment arm. 5 subjects were excluded by Investigator decision, 3 subjects withdrew consent for unkown reasons and 2 subjects withdrew based on insurance coverage considerations
Arm/Group Title Convergent Procedure Standalone Endocardial Catheter Ablation
Hide Arm/Group Description

Procedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment

AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax: Convergent Epicardial Endocardial Ablation Procedure

Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure

Procedure/Surgery: Endocardial Catheter Ablation Treatment

Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure

Period Title: Overall Study
Started [1] 115 [2] 55
Treated 102 51
Completed [3] 98 50
Not Completed 17 5
Reason Not Completed
Physician Decision             4             2
Withdrawal by Subject             2             2
Enrollment Closed             8             1
Insurance Coverage             1             0
Intra-operative Exclusion             2             0
[1]
FDA full approval
[2]
Date of full approval was 8/22/13. Date of first treated patient was 01/08/14
[3]
enrollment complete 153 treated
Arm/Group Title Convergent Procedure Standalone Endocardial Catheter Ablation Total
Hide Arm/Group Description

Procedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment

AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax: Convergent Epicardial Endocardial Ablation Procedure

Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure

Procedure/Surgery: Endocardial Catheter Ablation Treatment

Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure

Total of all reporting groups
Overall Number of Baseline Participants 102 51 153
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 51 participants 153 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
46
  45.1%
23
  45.1%
69
  45.1%
>=65 years
56
  54.9%
28
  54.9%
84
  54.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 51 participants 153 participants
Female
80
  78.4%
27
  52.9%
107
  69.9%
Male
22
  21.6%
24
  47.1%
46
  30.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 51 participants 153 participants
Hispanic or Latino
2
   2.0%
1
   2.0%
3
   2.0%
Not Hispanic or Latino
100
  98.0%
50
  98.0%
150
  98.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 51 participants 153 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   1.0%
0
   0.0%
1
   0.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
   4.9%
1
   2.0%
6
   3.9%
White
96
  94.1%
50
  98.0%
146
  95.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Height   [1] 
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 102 participants 51 participants 153 participants
177.7  (8.43) 173.9  (11.64) 176.5  (9.76)
[1]
Measure Description: Measure done in Centimeters.
Weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 102 participants 51 participants 153 participants
104.3  (19.985) 106.25  (23.903) 105.0  (21.31)
[1]
Measure Description: Measure reported in Kilograms
BMI   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/M2
Number Analyzed 102 participants 51 participants 153 participants
32.99  (5.861) 35.11  (7.128) 33.70  (6.37)
[1]
Measure Description: Measurements reported in Kg/M2
Smoking History  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 51 participants 153 participants
Never Smoked
45
  44.1%
28
  54.9%
73
  47.7%
Past Smoker
48
  47.1%
20
  39.2%
68
  44.4%
Current Smoker
9
   8.8%
2
   3.9%
11
   7.2%
Unknown
0
   0.0%
1
   2.0%
1
   0.7%
Persistent AF  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 51 participants 153 participants
Persistent AF
64
  62.7%
24
  47.1%
88
  57.5%
Long-Standing Persistent AF
38
  37.3%
27
  52.9%
65
  42.5%
1.Primary Outcome
Title Primary Efficacy Endpoint - Number of Participants to Achieve Freedom From AF/AT/AFL.
Hide Description This binary primary endpoint measures number of patients to achieve freedom from AF/AT/AFL absent class I and III AADs except for previously failed or intolerant I or III AAD with no increase in dosage following the 3-month blanking period through the 12 months post procedure follow-up visit will be compared between the two treatment groups using a chi-square test using a two-sided alpha of .05 to determine if superiority of the treatment arm is attained.
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Convergent Procedure Standalone Endocardial Catheter Ablation
Hide Arm/Group Description:

Procedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment

AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax: Convergent Epicardial Endocardial Ablation Procedure

Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure

Procedure/Surgery: Endocardial Catheter Ablation Treatment

Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure

Overall Number of Participants Analyzed 102 51
Measure Type: Count of Participants
Unit of Measure: Participants
67
  65.7%
25
  49.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Convergent Procedure, Standalone Endocardial Catheter Ablation
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0472
Comments A prior threshold for statistical significance was 0.05
Method Chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 16.7
Confidence Interval (2-Sided) 95%
0.1 to 33.2
Estimation Comments [Not Specified]
2.Primary Outcome
Title Primary Safety Analysis
Hide Description The primary safety analysis will measure the number of Major Adverse Events (MAE) collected from the start of the coagulation procedure to 30 days post procedure.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Convergent Procedure Standalone Endocardial Catheter Ablation
Hide Arm/Group Description:

Procedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment

AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax: Convergent Epicardial Endocardial Ablation Procedure

Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure

Procedure/Surgery: Endocardial Catheter Ablation Treatment

Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure

Overall Number of Participants Analyzed 102 51
Measure Type: Number
Unit of Measure: Number of events
8 0
3.Secondary Outcome
Title Secondary Safety Endpoint - Serious Adverse Events Through 12 Months Post-procedure.
Hide Description The secondary safety endpoint for the study was the number of participants with serious adverse events (SAEs) in the study through the 12-months post-procedure.
Time Frame 12 month
Hide Outcome Measure Data
Hide Analysis Population Description
Summary of Serious Adverse Events within 12 months occurring in >3% of the subjects in any treatment group (Safety Population)
Arm/Group Title Convergent Procedure Standalone Endocardial Catheter Ablation
Hide Arm/Group Description:

Procedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment

AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax: Convergent Epicardial Endocardial Ablation Procedure

Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure

Procedure/Surgery: Endocardial Catheter Ablation Treatment

Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure

Overall Number of Participants Analyzed 102 51
Measure Type: Count of Participants
Unit of Measure: Participants
Cardiac Disorders-Cardiac Tamponade
4
   3.9%
0
   0.0%
Cardiac Disorders- Pericardial Effusion
4
   3.9%
0
   0.0%
Cardiac Disorders- Pericarditis
3
   2.9%
0
   0.0%
Cardiac Disorders- Sinus Node Dysfunction
0
   0.0%
2
   3.9%
Cardiac Disorders-Cardiac Failure Congestive
5
   4.9%
1
   2.0%
Infections and Infestations- Pneumonia
3
   2.9%
4
   7.8%
Respiratory, Thoracic & Mediastinal Disorder- Pulmonary Edema
3
   2.9%
0
   0.0%
General Disorder and Administration Site-Chest Pain
3
   2.9%
0
   0.0%
Not applicable
77
  75.5%
44
  86.3%
4.Secondary Outcome
Title Number of Patients With AF Burden Reduction of at Least 90% at 12 Months Compared to Baseline
Hide Description AF Burden Reduction of at Least 90% at 12-Months (ITT Population): The first secondary effectiveness endpoint in the fixed-sequence testing was defined as at least 90% reduction in AF burden, absent of an increased dose or new class I/III AADs, at 12 months compared to baseline.
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of subjects in the EPi- Sense group that achieved at least 90% reduction at 12 months, compared to subjects in the Catheter Ablation group.
Arm/Group Title Convergent Procedure Standalone Endocardial Catheter Ablation
Hide Arm/Group Description:

Procedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment

AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax: Convergent Epicardial Endocardial Ablation Procedure

Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure

Procedure/Surgery: Endocardial Catheter Ablation Treatment

Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure

Overall Number of Participants Analyzed 102 51
Measure Type: Count of Participants
Unit of Measure: Participants
60
  58.8%
25
  49.0%
5.Secondary Outcome
Title AF Freedom Through 12 Months- Absent of an Increased Dose or New Class I/III AAD's.
Hide Description Number of patients with AF Freedom through 12 Months (ITT Population) absent of an increased dose or new class I/III AAD's
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Convergent Procedure Standalone Endocardial Catheter Ablation
Hide Arm/Group Description:

Procedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment

AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax: Convergent Epicardial Endocardial Ablation Procedure

Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure

Procedure/Surgery: Endocardial Catheter Ablation Treatment

Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure

Overall Number of Participants Analyzed 102 51
Mean (95% Confidence Interval)
Unit of Measure: percentage of participants
71
(61.7 to 79.4)
51
(37.4 to 64.7)
6.Secondary Outcome
Title Number of Subjects With AF Burden Reduction of at Least 90% at 12 Months Relative to Baseline, Regardless of Class I/III AADs.
Hide Description Number of subjects with AF freedom through 12 months achieved in the EPi-Sense group compared to subjects in the Catheter Ablation group.
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Convergent Procedure Standalone Endocardial Catheter Ablation
Hide Arm/Group Description:

Procedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment

AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax: Convergent Epicardial Endocardial Ablation Procedure

Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure

Procedure/Surgery: Endocardial Catheter Ablation Treatment

Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure

Overall Number of Participants Analyzed 102 51
Mean (95% Confidence Interval)
Unit of Measure: percentage of participants
95
(88.8 to 99.2)
88.6
(75.4 to 96.2)
7.Secondary Outcome
Title Change in Atrial Fibrillation Severity Scale (AFSS)
Hide Description Change was calculated as the value at 12 months minus the value at baseline. The University of Toronto's Atrial Fibrillation Severity Scale (AFSS) is a composite score of overall subject-perceived severity, global well-being, atrial fibrillation frequency, and atrial fibrillation duration. The score ranges from 3 to 30, with higher scores indicating greater atrial fibrillation burden.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Convergent Procedure Standalone Endocardial Catheter Ablation
Hide Arm/Group Description:

Procedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment

AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax: Convergent Epicardial Endocardial Ablation Procedure

Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure

Procedure/Surgery: Endocardial Catheter Ablation Treatment

Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure

Overall Number of Participants Analyzed 102 51
Mean (Standard Deviation)
Unit of Measure: score on a scale
-11.7  (7.71) -10.3  (7.16)
8.Secondary Outcome
Title Change in Quality of Life Physical Health Composite Scores Using Short Form Health Survey (SF-36)
Hide Description Change was calculated as the value at 12 months minus the value at baseline. The 36-Item Short Form Health Survey (SF-36) is used to determine a physical composite score composite score based on eight subscales: (1) limitations in physical activities because of health problems; (3) limitations in usual role activities because of physical health problems; (4) bodily pain; (5) vitality (energy and fatigue); and (6) general health perceptions. The subscale scores are transformed into a range from 0 to 100, with 0=worst HRQL, 100=best HRQL. The physical component scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score, with higher scores indicating better health status.
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects evaluated for quality of life using SF- 36 survey.
Arm/Group Title Convergent Procedure Standalone Endocardial Catheter Ablation
Hide Arm/Group Description:

Procedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment

AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax: Convergent Epicardial Endocardial Ablation Procedure

Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure

Procedure/Surgery: Endocardial Catheter Ablation Treatment

Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure

Overall Number of Participants Analyzed 102 51
Mean (Standard Deviation)
Unit of Measure: score on a scale
7.3  (10.67) 5.7  (10.49)
9.Secondary Outcome
Title Quality of Life-Change in SF-36 Mental Health Composite Score Using Short Form Survey (SF-36)
Hide Description Change was calculated as the value at 12 months minus the value at baseline. The 36-Item Short Form Health Survey (SF-36) is used to determine a physical composite score and mental composite score based on eight subscales: (1) limitations in physical activities because of health problems; (3) limitations in usual role activities because of physical health problems; (4) bodily pain; (5) general mental health (psychological distress and well-being); (6) limitations in usual role activities because of emotional problems; (7) vitality (energy and fatigue); and (8) general health perceptions. The subscale scores are transformed into a range from 0 to 100, with 0=worst HRQL, 100=best HRQL. The physical and mental component scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score, with higher scores indicating better health status.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Convergent Procedure Standalone Endocardial Catheter Ablation
Hide Arm/Group Description:

Procedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment

AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax: Convergent Epicardial Endocardial Ablation Procedure

Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure

Procedure/Surgery: Endocardial Catheter Ablation Treatment

Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure

Overall Number of Participants Analyzed 102 51
Mean (Standard Deviation)
Unit of Measure: score on a scale
5.7  (10.51) 7.7  (12.78)
10.Secondary Outcome
Title Change in 6-Minute Walk Score
Hide Description 6 minute walk score was measured by change from baseline compared to 12-months post-procedure between the EPi-Sense and Catheter Ablation groups.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Convergent Procedure Standalone Endocardial Catheter Ablation
Hide Arm/Group Description:

Procedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment

AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax: Convergent Epicardial Endocardial Ablation Procedure

Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure

Procedure/Surgery: Endocardial Catheter Ablation Treatment

Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure

Overall Number of Participants Analyzed 94 48
Mean (Standard Deviation)
Unit of Measure: Meters
9.2  (120.59) -12.4  (190.09)
11.Secondary Outcome
Title Change in Left Atrial Diameter
Hide Description Change in Left Atrial Diameter at 6 months from baseline.
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Convergent Procedure Standalone Endocardial Catheter Ablation
Hide Arm/Group Description:

Procedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment

AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax: Convergent Epicardial Endocardial Ablation Procedure

Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure

Procedure/Surgery: Endocardial Catheter Ablation Treatment

Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure

Overall Number of Participants Analyzed 99 51
Mean (Standard Deviation)
Unit of Measure: cm
0.1  (.62) 1.9  (6.68)
Time Frame 12-month post procedure
Adverse Event Reporting Description

ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not.

SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study.

MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related

 
Arm/Group Title Convergent Procedure Standalone Endocardial Catheter Ablation
Hide Arm/Group Description

Procedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment

AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax: Convergent Epicardial Endocardial Ablation Procedure

Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure

Procedure/Surgery: Endocardial Catheter Ablation Treatment

Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure

All-Cause Mortality
Convergent Procedure Standalone Endocardial Catheter Ablation
Affected / at Risk (%) Affected / at Risk (%)
Total   2/102 (1.96%)      0/51 (0.00%)    
Hide Serious Adverse Events
Convergent Procedure Standalone Endocardial Catheter Ablation
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   97/102 (95.10%)      41/51 (80.39%)    
Blood and lymphatic system disorders     
Anemia  3  1/102 (0.98%)  1 1/51 (1.96%)  1
Thrombocytopenia  3  1/102 (0.98%)  1 0/51 (0.00%)  0
Cardiac disorders     
Cardiac Failure Congestive  1  6/102 (5.88%)  6 2/51 (3.92%)  2
Cardiac Tamponade  1  4/102 (3.92%)  4 1/51 (1.96%)  1
Pericardial Effusion  1  4/102 (3.92%)  4 0/51 (0.00%)  0
Pericarditis  2  3/102 (2.94%)  3 0/51 (0.00%)  0
Sinus Node Dysfunction  3  0/102 (0.00%)  0 2/51 (3.92%)  2
Atrioventricular Block Complete  1  1/102 (0.98%)  1 0/51 (0.00%)  0
Bradycardia  1  1/102 (0.98%)  1 0/51 (0.00%)  0
Coronary Artery Disease  1  2/102 (1.96%)  2 0/51 (0.00%)  0
Mitral Valve Incompetence  1  0/102 (0.00%)  0 1/51 (1.96%)  1
Endocrine disorders     
Hyperthyroidism  3  1/102 (0.98%)  1 0/51 (0.00%)  0
Gastrointestinal disorders     
Abdominal Hernia  3  0/102 (0.00%)  0 0/51 (0.00%)  0
Diverticular Perforation  3  1/102 (0.98%)  1 0/51 (0.00%)  0
Enterocutaneous Fistula  3  1/102 (0.98%)  1 0/51 (0.00%)  0
Gastrointestinal Haemorrage  3  2/102 (1.96%)  2 1/51 (1.96%)  1
Gastrointestinal Ulcer Haemorrhage  3  1/102 (0.98%)  1 0/51 (0.00%)  0
Haemorrhoidal Haemorrhage  3  0/102 (0.00%)  0 1/51 (1.96%)  1
Hiatus Hernia  3  0/102 (0.00%)  0 1/51 (1.96%)  1
Intestinal Obstruction  3  1/102 (0.98%)  1 0/51 (0.00%)  0
Nausea  3  1/102 (0.98%)  1 0/51 (0.00%)  0
Salivary Gland Mass  3  1/102 (0.98%)  1 0/51 (0.00%)  0
Small Intestinal Obstruction  3  2/102 (1.96%)  2 0/51 (0.00%)  0
General disorders     
Chest Pain  3  4/102 (3.92%)  4 0/51 (0.00%)  0
Death  3  2/102 (1.96%)  2 0/51 (0.00%)  0
Multi-Organ Disorder  3  1/102 (0.98%)  1 0/51 (0.00%)  0
Oedema Peripheral  3  0/102 (0.00%)  0 1/51 (1.96%)  1
Hepatobiliary disorders     
Cholecystitis Acute  3  1/102 (0.98%)  1 0/51 (0.00%)  0
Immune system disorders     
Hypersensitivity  3  1/102 (0.98%)  1 0/51 (0.00%)  0
Infections and infestations     
Cellulitis  3  0/102 (0.00%)  0 2/51 (3.92%)  2
Cholecystitis Infective  3  1/102 (0.98%)  1 0/51 (0.00%)  0
Diverticulitis  3  0/102 (0.00%)  0 1/51 (1.96%)  1
Erysipelas  3  1/102 (0.98%)  1 0/51 (0.00%)  0
Herpes Zoster  3  1/102 (0.98%)  1 0/51 (0.00%)  0
Infection  3  3/102 (2.94%)  3 1/51 (1.96%)  1
Lobar Pneumonia  3  0/102 (0.00%)  0 1/51 (1.96%)  1
Lower Respiratory Tract Infection  3  1/102 (0.98%)  1 0/51 (0.00%)  0
Pneumonia  3  5/102 (4.90%)  5 4/51 (7.84%)  4
Pneumonia Bacterial  3  0/102 (0.00%)  0 1/51 (1.96%)  1
Pneumonia Staphlyococcal  3  0/102 (0.00%)  0 1/51 (1.96%)  1
Postoperative Wound Infectiion  3  1/102 (0.98%)  1 0/51 (0.00%)  0
Upper Respiratory Tract Infection  3  0/102 (0.00%)  0 1/51 (1.96%)  1
Urinary Tract Infection  3  0/102 (0.00%)  0 1/51 (1.96%)  1
Injury, poisoning and procedural complications     
Femur Fracture  3  1/102 (0.98%)  1 0/51 (0.00%)  0
Fibula Fracture  3  1/102 (0.98%)  1 0/51 (0.00%)  0
Incisional Hernia  3  1/102 (0.98%)  1 0/51 (0.00%)  0
Lower Limb Fracture  3  0/102 (0.00%)  0 1/51 (1.96%)  1
Nerve Injury  3  1/102 (0.98%)  1 0/51 (0.00%)  0
Post Procedure Haemorrhage  3  1/102 (0.98%)  1 0/51 (0.00%)  0
Traumatic Haemothorax  3  1/102 (0.98%)  1 0/51 (0.00%)  0
Vascular Access Complication  3  0/102 (0.00%)  0 1/51 (1.96%)  1
Investigations     
Toponian Increased  3  0/102 (0.00%)  0 1/51 (1.96%)  1
Metabolism and nutrition disorders     
Fluid Overload  3  2/102 (1.96%)  2 0/51 (0.00%)  0
Hyperkalaemia  3  1/102 (0.98%)  1 0/51 (0.00%)  0
Hypokalaemia  3  1/102 (0.98%)  1 0/51 (0.00%)  0
Hyponatraemia  3  2/102 (1.96%)  2 0/51 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Cervical Spinal Stenosis  3  1/102 (0.98%)  1 0/51 (0.00%)  0
Muscular Weakness  3  1/102 (0.98%)  1 0/51 (0.00%)  0
Vertebral Foraminal Stenosis  3  1/102 (0.98%)  1 0/51 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast Cancer Recurrent  3  0/102 (0.00%)  0 1/51 (1.96%)  1
Glioblastoma  3  1/102 (0.98%)  1 0/51 (0.00%)  0
Invasive Ductal Breast Carcinoma  3  1/102 (0.98%)  1 0/51 (0.00%)  0
Kaposi's Sarcoma  3  0/102 (0.00%)  0 1/51 (1.96%)  1
Mestastatic Malignant Melanoma  3  0/102 (0.00%)  0 1/51 (1.96%)  1
Nervous system disorders     
Cerebrovascular Accident  3  1/102 (0.98%)  1 0/51 (0.00%)  0
Cervical Myelopathy  3  0/102 (0.00%)  0 1/51 (1.96%)  1
Transient Ischaemic Attack  3  1/102 (0.98%)  1 0/51 (0.00%)  0
viith Nerve Paralysis  3  1/102 (0.98%)  1 0/51 (0.00%)  0
Psychiatric disorders     
Alcoholism  3  1/102 (0.98%)  1 0/51 (0.00%)  0
Depression  3  1/102 (0.98%)  1 0/51 (0.00%)  0
Renal and urinary disorders     
Acute Kidney Injury  3  1/102 (0.98%)  1 1/51 (1.96%)  1
Chronic Kidney Disease  3  1/102 (0.98%)  1 0/51 (0.00%)  0
Nephrolithiasis  3  0/102 (0.00%)  0 1/51 (1.96%)  1
Renal Failure  3  1/102 (0.98%)  1 0/51 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Acute Respitory Failure  3  1/102 (0.98%)  1 0/51 (0.00%)  0
Asthma  3  1/102 (0.98%)  1 0/51 (0.00%)  0
Chronic Obstructive Pulmonary Disease  3  1/102 (0.98%)  1 1/51 (1.96%)  1
Chronic Respitory Failure  3  1/102 (0.98%)  1 0/51 (0.00%)  0
Haemoptysis  3  0/102 (0.00%)  0 1/51 (1.96%)  1
Hypoxia  3  0/102 (0.00%)  0 1/51 (1.96%)  1
Organising Pneumonia  3  0/102 (0.00%)  0 1/51 (1.96%)  1
Plueral Effusion  3  2/102 (1.96%)  2 2/51 (3.92%)  2
Pleuratic Pain  3  1/102 (0.98%)  1 0/51 (0.00%)  0
Pulmonary Oedema  3  3/102 (2.94%)  3 0/51 (0.00%)  0
Surgical and medical procedures     
Cardiac Ablation  3  1/102 (0.98%)  1 0/51 (0.00%)  0
Colostomy Closure  3  1/102 (0.98%)  1 0/51 (0.00%)  0
knee Arthroplasty  3  2/102 (1.96%)  2 0/51 (0.00%)  0
Shoulder Arthroplasty  3  1/102 (0.98%)  1 0/51 (0.00%)  0
Vascular disorders     
Haematoma  3  0/102 (0.00%)  0 1/51 (1.96%)  1
Hypertensive Emergency  3  0/102 (0.00%)  0 1/51 (1.96%)  1
Jugular Vein Thrombosis  3  1/102 (0.98%)  1 0/51 (0.00%)  0
1
Term from vocabulary, MedDRA v18.0
2
Term from vocabulary, MedDRA v 18.0
3
Term from vocabulary, MedDRA (18.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Convergent Procedure Standalone Endocardial Catheter Ablation
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/102 (8.82%)      0/51 (0.00%)    
Cardiac disorders     
Tamponade  1 [1]  4/102 (3.92%)  4 0/51 (0.00%)  0
Excessive Bleeding  1 [1]  2/102 (1.96%)  2 0/51 (0.00%)  0
General disorders     
Stoke  1 [1]  1/102 (0.98%)  1 0/51 (0.00%)  0
Nervous system disorders     
Phrenic Nerve Injury  1 [1]  1/102 (0.98%)  1 0/51 (0.00%)  0
Transient Ischemic Attack  1 [1]  1/102 (0.98%)  1 0/51 (0.00%)  0
1
Term from vocabulary, MedDRA (18.0)
Indicates events were collected by systematic assessment
[1]
Major Adverse Event-Primary Safety Endpoint Measure (Safety Population)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director of Clinical Education
Organization: AtriCure
Phone: 513-560-5974
EMail: SGaynor@atricure.com
Layout table for additonal information
Responsible Party: AtriCure, Inc.
ClinicalTrials.gov Identifier: NCT01984346    
Other Study ID Numbers: VAL-1200
IDE Number G130084 ( Other Identifier: CDRH )
First Submitted: November 7, 2013
First Posted: November 14, 2013
Results First Submitted: August 12, 2021
Results First Posted: February 10, 2022
Last Update Posted: March 14, 2022