Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 18 of 1177 for:    adenosine

Adenosine to Assess Complete Conduction Block During Catheter Ablation of Paroxysmal Atrial Fibrillation

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: NCT03032965
Recruitment Status : Completed
First Posted : January 26, 2017
Results First Posted : December 13, 2017
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
Hamid Ghanbari, University of Michigan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Atrial Fibrillation
Interventions Drug: Adenosine
Drug: Isoproterenol
Enrollment 131
Recruitment Details  
Pre-assignment Details Two subjects were not randomized.
Arm/Group Title Adenosine and Isoproterenol Isoproterenol
Hide Arm/Group Description

Patients in this group will receive 12-24mg of adenosine for each PV in order to assess dormant PV conduction.

Adenosine: Subject will receive 6-24 mg of intravenous adenosine given rapidly for each PV in order to assess dormant PV conduction.

Subjects in this group will also receive isoproterenol to assess inducibility of AF with re-isolation of PVs and targeting non PV sources of AF if necessary.Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate.

Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol.

This group will not receive adenosine during the procedure.

Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol.

Period Title: Overall Study
Started 61 68
Completed 61 68
Not Completed 0 0
Arm/Group Title Adenosine and Isoproterenol Isoproterenol Total
Hide Arm/Group Description

Patients in this group will receive 12-24mg of adenosine for each PV in order to assess dormant PV conduction.

Adenosine: Subject will receive 6-24 mg of intravenous adenosine given rapidly for each PV in order to assess dormant PV conduction.

Subjects in this group will also receive isoproterenol to assess inducibility of AF with re-isolation of PVs and targeting non PV sources of AF if necessary.Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate.

Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol.

This group will not receive adenosine during the procedure.

Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol.

Total of all reporting groups
Overall Number of Baseline Participants 61 68 129
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 61 participants 68 participants 129 participants
59.7  (8.7) 58.9  (10.7) 59.3  (13.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 68 participants 129 participants
Female
24
  39.3%
15
  22.1%
39
  30.2%
Male
37
  60.7%
53
  77.9%
90
  69.8%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 61 participants 68 participants 129 participants
61
 100.0%
68
 100.0%
129
 100.0%
Left ventricular ejection fraction  
Mean (Standard Deviation)
Unit of measure:  Percentage
Number Analyzed 61 participants 68 participants 129 participants
59.7  (5.4) 59.3  (5.6) 59.5  (7.8)
left atrial diameter  
Mean (Standard Deviation)
Unit of measure:  Milli meters
Number Analyzed 61 participants 68 participants 129 participants
41.0  (5.3) 41.2  (6.4) 41.1  (8.3)
Hypertension   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 68 participants 129 participants
33
  54.1%
28
  41.2%
61
  47.3%
[1]
Measure Description: Participants with a documented history of hypertension or being treated for hypertension with medications
Diabetes Mellitus   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 68 participants 129 participants
6
   9.8%
8
  11.8%
14
  10.9%
[1]
Measure Description: participants with a history of diabetes mellitus or current treatment for diabetes
Obstructive sleep apnea   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 68 participants 129 participants
15
  24.6%
19
  27.9%
34
  26.4%
[1]
Measure Description: participants with a history of obstructive sleep apnea
Cerebrovascular accident   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 68 participants 129 participants
2
   3.3%
4
   5.9%
6
   4.7%
[1]
Measure Description: participants with a history of cerebrovascular accident
Repeat procedure   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 68 participants 129 participants
20
  32.8%
23
  33.8%
43
  33.3%
[1]
Measure Description: These are patients who had a previous ablation prior to entering the study
CHADS2 Score ( Congestive heart failure, Hypertension, Age > 75 years, Diabetes Mellitus, Stroke   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 61 participants 68 participants 129 participants
0.8  (0.7) 0.7  (0.7) 0.75  (0.9)
[1]
Measure Description: Each of these five variables is given 1 point for its presence, except stroke is given 2 points. Each individual point is added, so the score ranges possible are 0 to 6 where 0 represents no risk factors and 6 represents highest number of risk factors.
1.Primary Outcome
Title Freedom From Any Atrial Arrhythmias
Hide Description Primary endpoint of the study will be number of participants who are free from any atrial arrhythmias after a single ablation procedure in the absence of antiarrhythmic drug therapy
Time Frame 2- 14 months after Ablation procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adenosine and Isoproterenol Isoproterenol
Hide Arm/Group Description:

Patients in this group will receive 12-24mg of adenosine for each PV in order to assess dormant PV conduction.

Adenosine: Subject will receive 6-24 mg of intravenous adenosine given rapidly for each PV in order to assess dormant PV conduction.

Subjects in this group will also receive isoproterenol to assess inducibility of AF with re-isolation of PVs and targeting non PV sources of AF if necessary.Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate.

Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol.

This group will not receive adenosine during the procedure.

Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol.

Overall Number of Participants Analyzed 61 68
Measure Type: Count of Participants
Unit of Measure: Participants
24
  39.3%
23
  33.8%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adenosine and Isoproterenol, Isoproterenol
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .83
Comments [Not Specified]
Method Log Rank
Comments Kaplan Meier log rank
2.Secondary Outcome
Title Number of Subjects Who Need Repeat Ablations
Hide Description Number of participants who had one or more repeat ablation procedures due to documented recurrence of Symptomatic AF or atrial flutter/tachycardia.
Time Frame date of ablation to 6 months after procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adenosine and Isoproterenol Isoproterenol
Hide Arm/Group Description:

Patients in this group will receive 12-24mg of adenosine for each PV in order to assess dormant PV conduction.

Adenosine: Subject will receive 6-24 mg of intravenous adenosine given rapidly for each PV in order to assess dormant PV conduction.

Subjects in this group will also receive isoproterenol to assess inducibility of AF with re-isolation of PVs and targeting non PV sources of AF if necessary.Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate.

Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol.

This group will not receive adenosine during the procedure.

Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol.

Overall Number of Participants Analyzed 61 68
Measure Type: Count of Participants
Unit of Measure: Participants
12
  19.7%
9
  13.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adenosine and Isoproterenol, Isoproterenol
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .35
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Number of Subjects With AF or Atrial Flutter/Tachycardia Occurring During the First Three Months Post Ablation
Hide Description [Not Specified]
Time Frame first three months post ablation
Hide Outcome Measure Data
Hide Analysis Population Description
This data was not collected.
Arm/Group Title Adenosine and Isoproterenol Isoproterenol
Hide Arm/Group Description:

Patients in this group will receive 12-24mg of adenosine for each PV in order to assess dormant PV conduction.

Adenosine: Subject will receive 6-24 mg of intravenous adenosine given rapidly for each PV in order to assess dormant PV conduction.

Subjects in this group will also receive isoproterenol to assess inducibility of AF with re-isolation of PVs and targeting non PV sources of AF if necessary.Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate.

Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol.

This group will not receive adenosine during the procedure.

Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Number of Pulmonary Veins That Recovered Conduction During Repeat Ablation Procedures in Both Groups
Hide Description Prevalence of recovery of conduction into pulmonary veins during repeat ablation procedures in both groups. This is determined by surgeon assessment using a circular mapping catheter to identify recovery of conduction into the pulmonary veins.
Time Frame post-procedure (6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Only 21 participants had repeat ablations; each participant has four pulmonary veins therefore the number of connections measured is based 4 x the number of participants
Arm/Group Title Adenosine and Isoproterenol Isoproterenol
Hide Arm/Group Description:

Patients in this group will receive 12-24mg of adenosine for each PV in order to assess dormant PV conduction.

Adenosine: Subject will receive 6-24 mg of intravenous adenosine given rapidly for each PV in order to assess dormant PV conduction.

Subjects in this group will also receive isoproterenol to assess inducibility of AF with re-isolation of PVs and targeting non PV sources of AF if necessary.Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate.

Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol.

This group will not receive adenosine during the procedure.

Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol.

Overall Number of Participants Analyzed 12 9
Overall Number of Units Analyzed
Type of Units Analyzed: Pulmonary veins
48 36
Count of Units
Unit of Measure: pulmonary veins
29
  60.4%
28
  77.8%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adenosine and Isoproterenol, Isoproterenol
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Incidence of Stroke
Hide Description Number of subjects who develop stroke within 30 days after procedure.
Time Frame peri-procedural (0 to 30 days after procedure)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adenosine and Isoproterenol Isoproterenol
Hide Arm/Group Description:

Patients in this group will receive 12-24mg of adenosine for each PV in order to assess dormant PV conduction.

Adenosine: Subject will receive 6-24 mg of intravenous adenosine given rapidly for each PV in order to assess dormant PV conduction.

Subjects in this group will also receive isoproterenol to assess inducibility of AF with re-isolation of PVs and targeting non PV sources of AF if necessary.Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate.

Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol.

This group will not receive adenosine during the procedure.

Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol.

Overall Number of Participants Analyzed 61 68
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
6.Secondary Outcome
Title Incidence of Pulmonary Vein Stenosis
Hide Description Number of subjects who develop Symptomatic pulmonary vein stenosis
Time Frame 6 months post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adenosine and Isoproterenol Isoproterenol
Hide Arm/Group Description:

Patients in this group will receive 12-24mg of adenosine for each PV in order to assess dormant PV conduction.

Adenosine: Subject will receive 6-24 mg of intravenous adenosine given rapidly for each PV in order to assess dormant PV conduction.

Subjects in this group will also receive isoproterenol to assess inducibility of AF with re-isolation of PVs and targeting non PV sources of AF if necessary.Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate.

Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol.

This group will not receive adenosine during the procedure.

Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol.

Overall Number of Participants Analyzed 61 68
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
7.Secondary Outcome
Title Incidence of Cardiac Perforation
Hide Description Number of subjects who develop perforation of heart during ablation
Time Frame within 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adenosine and Isoproterenol Isoproterenol
Hide Arm/Group Description:

Patients in this group will receive 12-24mg of adenosine for each PV in order to assess dormant PV conduction.

Adenosine: Subject will receive 6-24 mg of intravenous adenosine given rapidly for each PV in order to assess dormant PV conduction.

Subjects in this group will also receive isoproterenol to assess inducibility of AF with re-isolation of PVs and targeting non PV sources of AF if necessary.Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate.

Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol.

This group will not receive adenosine during the procedure.

Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol.

Overall Number of Participants Analyzed 61 68
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
8.Secondary Outcome
Title Incidence of Atrio-esophageal Fistula
Hide Description Number of subjects who develop connection between heart and the esophagus
Time Frame within 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adenosine and Isoproterenol Isoproterenol
Hide Arm/Group Description:

Patients in this group will receive 12-24mg of adenosine for each PV in order to assess dormant PV conduction.

Adenosine: Subject will receive 6-24 mg of intravenous adenosine given rapidly for each PV in order to assess dormant PV conduction.

Subjects in this group will also receive isoproterenol to assess inducibility of AF with re-isolation of PVs and targeting non PV sources of AF if necessary.Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate.

Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol.

This group will not receive adenosine during the procedure.

Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol.

Overall Number of Participants Analyzed 61 68
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
9.Secondary Outcome
Title Incidence of Death
Hide Description Number of deaths within 90 days of the procedure.
Time Frame with 90 days of the procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adenosine and Isoproterenol Isoproterenol
Hide Arm/Group Description:

Patients in this group will receive 12-24mg of adenosine for each PV in order to assess dormant PV conduction.

Adenosine: Subject will receive 6-24 mg of intravenous adenosine given rapidly for each PV in order to assess dormant PV conduction.

Subjects in this group will also receive isoproterenol to assess inducibility of AF with re-isolation of PVs and targeting non PV sources of AF if necessary.Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate.

Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol.

This group will not receive adenosine during the procedure.

Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol.

Overall Number of Participants Analyzed 61 68
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
Time Frame within 24 hours of procedure
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adenosine and Isoproterenol Isoproterenol
Hide Arm/Group Description

Patients in this group will receive 12-24mg of adenosine for each PV in order to assess dormant PV conduction.

Adenosine: Subject will receive 6-24 mg of intravenous adenosine given rapidly for each PV in order to assess dormant PV conduction.

Subjects in this group will also receive isoproterenol to assess inducibility of AF with re-isolation of PVs and targeting non PV sources of AF if necessary.Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate.

Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol.

This group will not receive adenosine during the procedure.

Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol.

All-Cause Mortality
Adenosine and Isoproterenol Isoproterenol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/61 (0.00%)   0/68 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Adenosine and Isoproterenol Isoproterenol
Affected / at Risk (%) Affected / at Risk (%)
Total   4/61 (6.56%)   3/68 (4.41%) 
Respiratory, thoracic and mediastinal disorders     
Transient phrenic nerve paralysis  [1]  0/61 (0.00%)  1/68 (1.47%) 
Vascular disorders     
Site hematoma * [2]  2/61 (3.28%)  2/68 (2.94%) 
Pericardial Effusion  [3]  1/61 (1.64%)  0/68 (0.00%) 
A V Fistula  [4]  1/61 (1.64%)  0/68 (0.00%) 
Indicates events were collected by systematic assessment
[1]
Phrenic nerve paralysis.
*
Indicates events were collected by non-systematic assessment
[2]
Femoral vein/groin hematoma.
[3]
Pericardial effusion with hemodynamic compromise.
[4]
Arterio venous fistula between femoral artery and vein.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Adenosine and Isoproterenol Isoproterenol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/61 (0.00%)   0/68 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Hamid Ghanbari
Organization: University of Michigan
Phone: 734-963-7141
EMail: ghhamid@med.umich.edu
Layout table for additonal information
Responsible Party: Hamid Ghanbari, University of Michigan
ClinicalTrials.gov Identifier: NCT03032965     History of Changes
Other Study ID Numbers: HUM00048922
First Submitted: September 1, 2016
First Posted: January 26, 2017
Results First Submitted: September 28, 2017
Results First Posted: December 13, 2017
Last Update Posted: December 13, 2017