Trial Outcomes & Findings for A Study of the Effectiveness of Anti-Arrhythmic Medications After Atrial Fibrillation Ablation (NCT NCT00408200)

NCT ID: NCT00408200

Last Updated: 2013-03-07

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 110 participants
• Primary outcome timeframe: 6 weeks
• Results posted on: 2013-03-07

Participant Flow

Recruitment period: 12/06 to 3/08.

Following consent/enrollment, subject and investigator were blinded to treatment arm until after the ablation procedure. Subjects were later withdrawn if the procedure was not completed, or if a disqualifying medication history or other protocol exclusion was identified.

Participant milestones

Measure	AAD:NO Subjects do not receive membrane-active anti-arrhythmic medications after ablation. Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates.	AAD:YES Subjects receive membrane-active anti-arrhythmic medication after ablation. See intervention list below. Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates. propafenone; flecainide; sotalol; dofetilide : Above drugs prescribed per established guidelines for treatment of AF
Overall Study STARTED	57	53
Overall Study COMPLETED	57	53
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of the Effectiveness of Anti-Arrhythmic Medications After Atrial Fibrillation Ablation

Baseline characteristics by cohort

Measure	AAD:NO n=57 Participants Subjects do not receive membrane-active anti-arrhythmic medications after ablation. Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates.	AAD:YES n=53 Participants Subjects receive membrane-active anti-arrhythmic medication after ablation. See intervention list below. Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates. propafenone; flecainide; sotalol; dofetilide : Above drugs prescribed per established guidelines for treatment of AF	Total n=110 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	57 Participants n=5 Participants	53 Participants n=7 Participants	110 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Sex: Female, Male Male	41 Participants n=5 Participants	37 Participants n=7 Participants	78 Participants n=5 Participants
Region of Enrollment United States	57 participants n=5 Participants	53 participants n=7 Participants	110 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: Assuming an incidence of the composite primary end point of 40% in the control group and a 50% reduction in the composite primary end point in the drug treatment group, we calculated that 160 patients would have to be included in the study in order to obtain a power of 80% and with a 2-tailed error of 0.05.

Outcome measures

Measure	AAD:NO n=57 Participants Subjects do not receive membrane-active anti-arrhythmic medications after ablation. Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates.	AAD:YES n=53 Participants Subjects receive membrane-active anti-arrhythmic medication after ablation. See intervention list below. Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates. propafenone; flecainide; sotalol; dofetilide : Above drugs prescribed per established guidelines for treatment of AF
Composite Endpoint: Atrial Arrhythmias Lasting >24 Hrs or Requiring Antiarrhythmic Drug Therapy; Need for Cardioversion/Repeat Ablation During the Study Period; Adverse Outcome/Intolerance of Antiarrhythmic Agent Requiring Cessation or Change of Drug	24 participants	10 participants

SECONDARY outcome

Timeframe: 6 weeks

Population: Assuming an incidence of the composite primary end point of 40% in the control group and a 50% reduction in the composite primary end point in the drug treatment group, we calculated that 160 patients would have to be included in the study in order to obtain a power of 80% and with a 2-tailed error of 0.05.

Outcome measures

Measure	AAD:NO n=57 Participants Subjects do not receive membrane-active anti-arrhythmic medications after ablation. Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates.	AAD:YES n=53 Participants Subjects receive membrane-active anti-arrhythmic medication after ablation. See intervention list below. Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates. propafenone; flecainide; sotalol; dofetilide : Above drugs prescribed per established guidelines for treatment of AF
Freedom From Atrial Arrhythmia at 6 Months Post Procedure.	39 participants	35 participants

Adverse Events

AAD:NO

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

AAD:YES

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Anthony Killian

University of Pennsylvania

Phone: 215-615-5299

Email: tony.killian@uphs.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place