Trial Outcomes & Findings for Ablation vs Drug Therapy for Atrial Fibrillation - Pilot Trial (NCT NCT00578617)
NCT ID: NCT00578617
Last Updated: 2013-01-04
Results Overview
Documentation of atrial fibrillation using a cardiac event recorder
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
12 months after intervention
Results posted on
2013-01-04
Participant Flow
Participant milestones
| Measure |
Drug Therapy
Pharmacologic Therapy Rate and/or Rhythm Control: MD to choose from this list as medically indicated, doses are min recommended daily dose: metoprolol 50-100 mg, atenolol 50-100 mg, propanolol 40-80 mg, acebutolol 200 mg, carvedilol 6.25 mg, diltiazem 180-240 mg, verapamil 180-240 mg, digoxin 0.125 mg, propafenone 450 mg, flecainide 200 mg, sotalol 240 mg, dofetilide 500 mcg, amiodarone 200 mg, quinidine 600-900 mcg.
|
Ablation Therapy
Left Atrial Catheter Ablation: The specific choice of ablation catheters will be left to the investigator from the following list: Lifewire TC XLS, Therapy Dual/Thermocouple, NAVI-STAR/NAVI-STAR DS, Celsius Braided Tip, NAVI-STAR Thermo-Cool, Freezor/FreezorMax, Stinger, Blazer II RF/RPM/SteeroCath /XP, Chilli Cooled.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
29
|
|
Overall Study
COMPLETED
|
31
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ablation vs Drug Therapy for Atrial Fibrillation - Pilot Trial
Baseline characteristics by cohort
| Measure |
Drug Therapy
n=31 Participants
Pharmacologic Therapy Rate and/or Rhythm Control: MD to choose from this list as medically indicated, doses are min recommended daily dose: metoprolol 50-100 mg, atenolol 50-100 mg, propanolol 40-80 mg, acebutolol 200 mg, carvedilol 6.25 mg, diltiazem 180-240 mg, verapamil 180-240 mg, digoxin 0.125 mg, propafenone 450 mg, flecainide 200 mg, sotalol 240 mg, dofetilide 500 mcg, amiodarone 200 mg, quinidine 600-900 mcg.
|
Ablation Therapy
n=29 Participants
Left Atrial Catheter Ablation: The specific choice of ablation catheters will be left to the investigator from the following list: Lifewire TC XLS, Therapy Dual/Thermocouple, NAVI-STAR/NAVI-STAR DS, Celsius Braided Tip, NAVI-STAR Thermo-Cool, Freezor/FreezorMax, Stinger, Blazer II RF/RPM/SteeroCath /XP, Chilli Cooled.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Age Continuous
|
62.1 years
STANDARD_DEVIATION 9.57 • n=5 Participants
|
60.3 years
STANDARD_DEVIATION 11.46 • n=7 Participants
|
61.2 years
STANDARD_DEVIATION 10.47 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
29 participants
n=7 Participants
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 months after interventionDocumentation of atrial fibrillation using a cardiac event recorder
Outcome measures
| Measure |
Drug Therapy
n=31 Participants
Pharmacologic Therapy Rate and/or Rhythm Control: MD to choose from this list as medically indicated, doses are min recommended daily dose: metoprolol 50-100 mg, atenolol 50-100 mg, propanolol 40-80 mg, acebutolol 200 mg, carvedilol 6.25 mg, diltiazem 180-240 mg, verapamil 180-240 mg, digoxin 0.125 mg, propafenone 450 mg, flecainide 200 mg, sotalol 240 mg, dofetilide 500 mcg, amiodarone 200 mg, quinidine 600-900 mcg.
|
Ablation Therapy
n=29 Participants
Left Atrial Catheter Ablation: The specific choice of ablation catheters will be left to the investigator from the following list: Lifewire TC XLS, Therapy Dual/Thermocouple, NAVI-STAR/NAVI-STAR DS, Celsius Braided Tip, NAVI-STAR Thermo-Cool, Freezor/FreezorMax, Stinger, Blazer II RF/RPM/SteeroCath /XP, Chilli Cooled.
|
|---|---|---|
|
Number of Participants Experiencing Recurrence of Atrial Fibrillation by One Year Follow-up
|
20 participants
|
14 participants
|
Adverse Events
Drug Therapy
Serious events: 4 serious events
Other events: 8 other events
Deaths: 0 deaths
Ablation Therapy
Serious events: 12 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Drug Therapy
n=31 participants at risk
Pharmacologic Therapy Rate and/or Rhythm Control: MD to choose from this list as medically indicated, doses are min recommended daily dose: metoprolol 50-100 mg, atenolol 50-100 mg, propanolol 40-80 mg, acebutolol 200 mg, carvedilol 6.25 mg, diltiazem 180-240 mg, verapamil 180-240 mg, digoxin 0.125 mg, propafenone 450 mg, flecainide 200 mg, sotalol 240 mg, dofetilide 500 mcg, amiodarone 200 mg, quinidine 600-900 mcg.
|
Ablation Therapy
n=29 participants at risk
Left Atrial Catheter Ablation: The specific choice of ablation catheters will be left to the investigator from the following list: Lifewire TC XLS, Therapy Dual/Thermocouple, NAVI-STAR/NAVI-STAR DS, Celsius Braided Tip, NAVI-STAR Thermo-Cool, Freezor/FreezorMax, Stinger, Blazer II RF/RPM/SteeroCath /XP, Chilli Cooled.
|
|---|---|---|
|
Cardiac disorders
Ventricular Tachycardia
|
3.2%
1/31 • Number of events 1 • Subjects were followed for adverse events for the 1 year they were on this trial.
|
0.00%
0/29 • Subjects were followed for adverse events for the 1 year they were on this trial.
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/31 • Subjects were followed for adverse events for the 1 year they were on this trial.
|
3.4%
1/29 • Number of events 1 • Subjects were followed for adverse events for the 1 year they were on this trial.
|
|
Cardiac disorders
Atrial Fibrillation
|
3.2%
1/31 • Number of events 2 • Subjects were followed for adverse events for the 1 year they were on this trial.
|
3.4%
1/29 • Number of events 2 • Subjects were followed for adverse events for the 1 year they were on this trial.
|
|
General disorders
Adverse
|
3.2%
1/31 • Number of events 1 • Subjects were followed for adverse events for the 1 year they were on this trial.
|
0.00%
0/29 • Subjects were followed for adverse events for the 1 year they were on this trial.
|
|
Cardiac disorders
Cardiac Tamponade
|
0.00%
0/31 • Subjects were followed for adverse events for the 1 year they were on this trial.
|
3.4%
1/29 • Number of events 1 • Subjects were followed for adverse events for the 1 year they were on this trial.
|
|
Vascular disorders
Vascular Pseudoaneurysm
|
0.00%
0/31 • Subjects were followed for adverse events for the 1 year they were on this trial.
|
3.4%
1/29 • Number of events 1 • Subjects were followed for adverse events for the 1 year they were on this trial.
|
|
Infections and infestations
Device Related Infection
|
0.00%
0/31 • Subjects were followed for adverse events for the 1 year they were on this trial.
|
3.4%
1/29 • Number of events 1 • Subjects were followed for adverse events for the 1 year they were on this trial.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/31 • Subjects were followed for adverse events for the 1 year they were on this trial.
|
3.4%
1/29 • Number of events 1 • Subjects were followed for adverse events for the 1 year they were on this trial.
|
|
Infections and infestations
Infection
|
0.00%
0/31 • Subjects were followed for adverse events for the 1 year they were on this trial.
|
3.4%
1/29 • Number of events 1 • Subjects were followed for adverse events for the 1 year they were on this trial.
|
|
Cardiac disorders
Coronary Artery Occlusion
|
0.00%
0/31 • Subjects were followed for adverse events for the 1 year they were on this trial.
|
3.4%
1/29 • Number of events 1 • Subjects were followed for adverse events for the 1 year they were on this trial.
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/31 • Subjects were followed for adverse events for the 1 year they were on this trial.
|
3.4%
1/29 • Number of events 1 • Subjects were followed for adverse events for the 1 year they were on this trial.
|
|
Cardiac disorders
Pericardial Effusion
|
0.00%
0/31 • Subjects were followed for adverse events for the 1 year they were on this trial.
|
3.4%
1/29 • Number of events 1 • Subjects were followed for adverse events for the 1 year they were on this trial.
|
|
Vascular disorders
Arteriovenous Fistula
|
0.00%
0/31 • Subjects were followed for adverse events for the 1 year they were on this trial.
|
3.4%
1/29 • Number of events 1 • Subjects were followed for adverse events for the 1 year they were on this trial.
|
|
Cardiac disorders
Ischaemia
|
0.00%
0/31 • Subjects were followed for adverse events for the 1 year they were on this trial.
|
3.4%
1/29 • Number of events 1 • Subjects were followed for adverse events for the 1 year they were on this trial.
|
Other adverse events
| Measure |
Drug Therapy
n=31 participants at risk
Pharmacologic Therapy Rate and/or Rhythm Control: MD to choose from this list as medically indicated, doses are min recommended daily dose: metoprolol 50-100 mg, atenolol 50-100 mg, propanolol 40-80 mg, acebutolol 200 mg, carvedilol 6.25 mg, diltiazem 180-240 mg, verapamil 180-240 mg, digoxin 0.125 mg, propafenone 450 mg, flecainide 200 mg, sotalol 240 mg, dofetilide 500 mcg, amiodarone 200 mg, quinidine 600-900 mcg.
|
Ablation Therapy
n=29 participants at risk
Left Atrial Catheter Ablation: The specific choice of ablation catheters will be left to the investigator from the following list: Lifewire TC XLS, Therapy Dual/Thermocouple, NAVI-STAR/NAVI-STAR DS, Celsius Braided Tip, NAVI-STAR Thermo-Cool, Freezor/FreezorMax, Stinger, Blazer II RF/RPM/SteeroCath /XP, Chilli Cooled.
|
|---|---|---|
|
Vascular disorders
Vascular Injury
|
3.2%
1/31 • Number of events 1 • Subjects were followed for adverse events for the 1 year they were on this trial.
|
6.9%
2/29 • Number of events 2 • Subjects were followed for adverse events for the 1 year they were on this trial.
|
|
Vascular disorders
Haematoma
|
3.2%
1/31 • Number of events 1 • Subjects were followed for adverse events for the 1 year they were on this trial.
|
6.9%
2/29 • Number of events 2 • Subjects were followed for adverse events for the 1 year they were on this trial.
|
|
General disorders
Rash
|
9.7%
3/31 • Number of events 3 • Subjects were followed for adverse events for the 1 year they were on this trial.
|
0.00%
0/29 • Subjects were followed for adverse events for the 1 year they were on this trial.
|
|
Gastrointestinal disorders
Nausea
|
9.7%
3/31 • Number of events 3 • Subjects were followed for adverse events for the 1 year they were on this trial.
|
0.00%
0/29 • Subjects were followed for adverse events for the 1 year they were on this trial.
|
|
Vascular disorders
Transient Ischaemic Attack
|
0.00%
0/31 • Subjects were followed for adverse events for the 1 year they were on this trial.
|
3.4%
1/29 • Number of events 1 • Subjects were followed for adverse events for the 1 year they were on this trial.
|
|
Metabolism and nutrition disorders
Fluid Overload
|
0.00%
0/31 • Subjects were followed for adverse events for the 1 year they were on this trial.
|
6.9%
2/29 • Number of events 2 • Subjects were followed for adverse events for the 1 year they were on this trial.
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/31 • Subjects were followed for adverse events for the 1 year they were on this trial.
|
10.3%
3/29 • Number of events 3 • Subjects were followed for adverse events for the 1 year they were on this trial.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place