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FIRM Ablation Versus Pulmonary Vein Isolation for the Treatment of Paroxysmal Atrial Fibrillation (PAF) (FIRMAP-AF)

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ClinicalTrials.gov Identifier: NCT02703454
Recruitment Status : Terminated
First Posted : March 9, 2016
Results First Posted : May 21, 2019
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Paroxysmal Atrial Fibrillation
Interventions Procedure: FIRM-guided RF ablation
Procedure: Conventional RF ablation
Enrollment 51
Recruitment Details  
Pre-assignment Details  
Arm/Group Title FIRM-only Conventional
Hide Arm/Group Description

Subjects in this arm will be treated with Focal Impulse and Rotor Modulation (FIRM)-guided conventional radio frequency (RF) ablation without pulmonary vein isolation (PVI).

FIRM-guided RF ablation

Subjects in this arm will undergo conventional RF ablation with confirmation of PVI.

Conventional RF ablation

Period Title: Overall Study
Started 24 27
Treated 23 24
Completed 13 11
Not Completed 11 16
Reason Not Completed
Not treated             1             3
Withdrawal by Subject             4             3
Lost to Follow-up             1             2
Study discontinuation             5             8
Arm/Group Title FIRM-only Conventional Total
Hide Arm/Group Description

Subjects in this arm will be treated with FIRM-guided conventional RF ablation without pulmonary vein isolation (PVI).

FIRM-guided RF ablation

Subjects in this arm will undergo conventional RF ablation with confirmation of PVI.

Conventional RF ablation

Total of all reporting groups
Overall Number of Baseline Participants 24 27 51
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 27 participants 51 participants
62  (11.4) 65  (9.7) 63  (10.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 27 participants 51 participants
Female
10
  41.7%
12
  44.4%
22
  43.1%
Male
14
  58.3%
15
  55.6%
29
  56.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 27 participants 51 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
24
 100.0%
25
  92.6%
49
  96.1%
Unknown or Not Reported
0
   0.0%
2
   7.4%
2
   3.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 27 participants 51 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
24
 100.0%
26
  96.3%
50
  98.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   3.7%
1
   2.0%
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 24 participants 27 participants 51 participants
27  (6.2) 28  (5.5) 28  (5.8)
European Heart Rhythm Association (EHRA) symptom classification in atrial fibrillation (AF)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 27 participants 51 participants
Class I
2
   8.3%
0
   0.0%
2
   3.9%
Class II
8
  33.3%
7
  25.9%
15
  29.4%
Class III
14
  58.3%
18
  66.7%
32
  62.7%
Class IV
0
   0.0%
1
   3.7%
1
   2.0%
Unknown
0
   0.0%
1
   3.7%
1
   2.0%
[1]
Measure Description:

The EHRA score considers symptoms that are attributable to AF and reverse or reduce upon restoration of sinus rhythm or with effective rate control.

Classification of AF-related symptoms (EHRA score) are as follows:

EHRA I - ‘No symptoms’ EHRA II - ‘Mild symptoms’; normal daily activity not affected EHRA III - ‘Severe symptoms’; normal daily activity affected EHRA IV - ‘Disabling symptoms’; normal daily activity discontinued

Reference:(1) Eur Heart J. 2010 (19):2369-429

History of Arterial Hypertension  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 27 participants 51 participants
Yes
11
  45.8%
13
  48.1%
24
  47.1%
No
9
  37.5%
8
  29.6%
17
  33.3%
Unknown
4
  16.7%
6
  22.2%
10
  19.6%
History of Coronary Artery Disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 27 participants 51 participants
Yes
8
  33.3%
8
  29.6%
16
  31.4%
No
12
  50.0%
13
  48.1%
25
  49.0%
Unknown
4
  16.7%
6
  22.2%
10
  19.6%
History of Chronic Renal Insufficiency  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 27 participants 51 participants
Yes
2
   8.3%
3
  11.1%
5
   9.8%
No
18
  75.0%
18
  66.7%
36
  70.6%
Unknown
4
  16.7%
6
  22.2%
10
  19.6%
Left Atrial Diameter  
Mean (Standard Deviation)
Unit of measure:  Mm
Number Analyzed 24 participants 27 participants 51 participants
44  (5.5) 44  (7.3) 44  (6.4)
Anti-Arrhythmic Use at Baseline: Amiodarone  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 27 participants 51 participants
Yes
2
   8.3%
0
   0.0%
2
   3.9%
No
22
  91.7%
25
  92.6%
47
  92.2%
Unknown
0
   0.0%
2
   7.4%
2
   3.9%
Anti-Arrhythmic Use at Baseline: Dronedarone  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 27 participants 51 participants
Yes
0
   0.0%
0
   0.0%
0
   0.0%
No
24
 100.0%
25
  92.6%
49
  96.1%
Unknown
0
   0.0%
2
   7.4%
2
   3.9%
Anti-Arrhythmic Use at Baseline: Flecainide  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 27 participants 51 participants
Yes
4
  16.7%
7
  25.9%
11
  21.6%
No
20
  83.3%
18
  66.7%
38
  74.5%
Unknown
0
   0.0%
2
   7.4%
2
   3.9%
Anti-Arrhythmic Use at Baseline: Propafenone  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 27 participants 51 participants
Yes
1
   4.2%
0
   0.0%
1
   2.0%
No
23
  95.8%
25
  92.6%
48
  94.1%
Unknown
0
   0.0%
2
   7.4%
2
   3.9%
Anti-Arrhythmic Use at Baseline: Sotalol  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 27 participants 51 participants
Yes
0
   0.0%
2
   7.4%
2
   3.9%
No
24
 100.0%
23
  85.2%
47
  92.2%
Unknown
0
   0.0%
2
   7.4%
2
   3.9%
1.Primary Outcome
Title Number of Participants With Single-procedure Freedom From AF/AT Recurrence From 3-12 Months Post Index Ablation Procedure
Hide Description Freedom from AF/AT recurrence is defined as no documented episodes of AF/AT > 30 seconds with conventional non-invasive monitoring. In the case of a cardiac implanted electronic device (CIED), freedom from AF recurrence is defined as no documented episodes of AF/AT > 30 seconds in a 72-hour window at the follow-up visits in addition to any symptomatic episodes with documented AF > 30 seconds. AT recurrence does not include episodes of cavotricuspid isthmus (CTI) dependent flutter.
Time Frame 3 -12 months post study treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with 12-month follow-up data
Arm/Group Title FIRM-only Conventional
Hide Arm/Group Description:

Subjects in this arm will be treated with FIRM-guided conventional RF ablation without pulmonary vein isolation (PVI).

FIRM-guided RF ablation

Subjects in this arm will undergo conventional RF ablation with confirmation of PVI.

Conventional RF ablation

Overall Number of Participants Analyzed 16 10
Measure Type: Count of Participants
Unit of Measure: Participants
5
  31.3%
8
  80.0%
2.Secondary Outcome
Title Number of Participants With Freedom From Procedure-related Serious Adverse Events
Hide Description Freedom from procedure-related serious adverse events within one year of the index procedure
Time Frame Within 1 year post study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with 12 month safety data
Arm/Group Title FIRM-only Conventional
Hide Arm/Group Description:

Subjects in this arm will be treated with FIRM-guided conventional RF ablation without pulmonary vein isolation (PVI).

FIRM-guided RF ablation

Subjects in this arm will undergo conventional RF ablation with confirmation of PVI.

Conventional RF ablation

Overall Number of Participants Analyzed 15 14
Measure Type: Count of Participants
Unit of Measure: Participants
12
  80.0%
14
 100.0%
Time Frame Adverse event data was collected up to 1 year post index procedure.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title FIRM-only Conventional
Hide Arm/Group Description

Subjects in this arm will be treated with FIRM-guided conventional RF ablation without pulmonary vein isolation (PVI).

FIRM-guided RF ablation

Subjects in this arm will undergo conventional RF ablation with confirmation of PVI.

Conventional RF ablation

All-Cause Mortality
FIRM-only Conventional
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)      0/27 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
FIRM-only Conventional
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/24 (50.00%)      4/27 (14.81%)    
Cardiac disorders     
Atrial Fibrillation   1/24 (4.17%)  1 0/27 (0.00%)  0
Atrial Flutter   1/24 (4.17%)  1 0/27 (0.00%)  0
Atrial Tachycardia   1/24 (4.17%)  2 0/27 (0.00%)  0
Cardiac Failure   0/24 (0.00%)  0 1/27 (3.70%)  1
Gastrointestinal disorders     
Gastroenteritis   1/24 (4.17%)  1 0/27 (0.00%)  0
General disorders     
Accidental Exposure to Product   0/24 (0.00%)  0 1/27 (3.70%)  1
Fracture Of Distale Radius Left, Orbita And Maxillary Sinus   1/24 (4.17%)  1 0/27 (0.00%)  0
Hepatobiliary disorders     
Liver Abscess   1/24 (4.17%)  1 0/27 (0.00%)  0
Infections and infestations     
Pneumonia   1/24 (4.17%)  1 1/27 (3.70%)  1
Metabolism and nutrition disorders     
Blood Sodium Decreased   0/24 (0.00%)  0 1/27 (3.70%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Chondromatosis   0/24 (0.00%)  0 1/27 (3.70%)  1
Nervous system disorders     
Phrenic Nerve Paralysis   1/24 (4.17%)  1 0/27 (0.00%)  0
Psychiatric disorders     
Suspected Dementia With Hospitalisation Due To Diagnostic Tests   1/24 (4.17%)  1 0/27 (0.00%)  0
Renal and urinary disorders     
Acute Kidney Injury   0/24 (0.00%)  0 1/27 (3.70%)  1
Respiratory, thoracic and mediastinal disorders     
Pulmonary Fibrosis   1/24 (4.17%)  1 0/27 (0.00%)  0
Vascular disorders     
Aneurysma Aorta Ascendens   0/24 (0.00%)  0 1/27 (3.70%)  1
Aortic Valve Stenosis   0/24 (0.00%)  0 1/27 (3.70%)  1
Bleeding Aneamia   0/24 (0.00%)  0 1/27 (3.70%)  1
Carotid Artery Stenosis   1/24 (4.17%)  1 0/27 (0.00%)  0
Cerebral Infarction   0/24 (0.00%)  0 1/27 (3.70%)  1
Coronary Artery Disease   0/24 (0.00%)  0 1/27 (3.70%)  1
Femoral Artery Occlusion   0/24 (0.00%)  0 1/27 (3.70%)  1
Femoral Artery Aneurysm   1/24 (4.17%)  1 0/27 (0.00%)  0
Hypertension   0/24 (0.00%)  0 1/27 (3.70%)  1
Haematoma, Injection Site   2/24 (8.33%)  2 0/27 (0.00%)  0
Haematoma, Right Groin   1/24 (4.17%)  1 0/27 (0.00%)  0
Occlusion Of Arteria Femoralis Pop-Iii-Bypass Right Side   0/24 (0.00%)  0 1/27 (3.70%)  1
Peripheral Ischaemia   0/24 (0.00%)  0 1/27 (3.70%)  1
Syncope   0/24 (0.00%)  0 2/27 (7.41%)  2
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
FIRM-only Conventional
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/24 (16.67%)      1/27 (3.70%)    
Cardiac disorders     
Atrial Fibrillation   4/24 (16.67%)  4 1/27 (3.70%)  1
Indicates events were collected by systematic assessment
Early termination led to small numbers of subjects analyzed
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.
The data and results from this study are the sole property of Sponsor. Investigators will not use data from this clinical investigation without the written consent of the Sponsor or generate publication materials as referenced in the Clinical Trial Agreement Single-center results are not allowed to be published or presented before the multi-center results.
Results Point of Contact
Name/Title: Clinical Program Director
Organization: Abbott
Phone: 6517566717
Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02703454     History of Changes
Other Study ID Numbers: CLN - 107
First Submitted: March 4, 2016
First Posted: March 9, 2016
Results First Submitted: February 25, 2019
Results First Posted: May 21, 2019
Last Update Posted: May 21, 2019