A Comparison of Antiarrhythmic Drug Therapy and Radio Frequency Catheter Ablation in Patients With Paroxysmal Atrial Fibrillation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-01

Study Completion Date

2006-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to compare radiofrequency catheter ablation and antiarrhythmic drug treatment for the maintenance of sinus rhythm in paroxysmal atrial fibrillation patients.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

STOP AF First: Cryoballoon Catheter Ablation in an Antiarrhythmic Drug Naive Paroxysmal Atrial Fibrillation

NCT03118518

Atrial Fibrillation Atrial Fibrillation New Onset

COMPLETED NA

Radiofrequency Catheter Ablation for Chronic Atrial Fibrillation

NCT00272636

Atrial Fibrillation

COMPLETED NA

Clinical Outcomes of Persistent Atrial Fibrillation Ablation Using Ablation Index-guided Radiofrequency Catheter Ablation in Patients With Continuous Monitoring

NCT05406310

Persistent Atrial Fibrillation

WITHDRAWN

Pulsed Field Ablation (PFA) vs Anti-Arrhythmic Drug (AAD) Therapy as a First Line Treatment for Persistent Atrial Fibrillation

NCT06096337

Persistent Atrial Fibrillation

ACTIVE_NOT_RECRUITING NA

A Clinical Study of the Arctic Front Cryoablation Balloon for the Treatment of Paroxysmal Atrial Fibrillation

NCT00523978

Paroxysmal Atrial Fibrillation

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Paroxysmal Atrial Fibrillation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Drug Treatment

Group Type ACTIVE_COMPARATOR

Radiofrequency ablation, antiarrhythmic drugs

Intervention Type DEVICE

Patients receive either treatment.

Amiodarone, flecainide, propafenone, quinidine, dofetilide, sotalol, cibenzoline, beta blocking and calcium channel blocking agents and antiarrhythmic drugs

Intervention Type DRUG

Amiodarone will be taken at 600 mg per day for 21 days (as a loading dose) followed by 1.4g per week or 200mg per day. The daily dose may be increased to 300mg or 2.1g per week.

ThermoCool Radiofrequency Catheter

Radiofrequency catheter used.

Group Type ACTIVE_COMPARATOR

Radiofrequency ablation, antiarrhythmic drugs

Intervention Type DEVICE

Patients receive either treatment.

ThermoCool Radiofrequency Catheter

Intervention Type DEVICE

Patient is ablated once, repeat ablation if paroxysmal atrial fibrillation reoccurs.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Radiofrequency ablation, antiarrhythmic drugs

Patients receive either treatment.

Intervention Type DEVICE

Amiodarone, flecainide, propafenone, quinidine, dofetilide, sotalol, cibenzoline, beta blocking and calcium channel blocking agents and antiarrhythmic drugs

Amiodarone will be taken at 600 mg per day for 21 days (as a loading dose) followed by 1.4g per week or 200mg per day. The daily dose may be increased to 300mg or 2.1g per week.

Intervention Type DRUG

ThermoCool Radiofrequency Catheter

Patient is ablated once, repeat ablation if paroxysmal atrial fibrillation reoccurs.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 18 years of age or older
* Paroxysmal atrial fibrillation for at least 6 months with at least 2 symptomatic episodes (patient history) during the previous month
* Atrial fibrillation (patient history or echocardiogram documented) resistant to at least one antiarrhythmic drug of Class I or III
* Documentation of at least one episode of atrial fibrillation on 12-lead echocardiogram or Holter Monitor

Exclusion Criteria

* Contraindications to more than 2 antiarrhythmic drugs of different classes, or to oral anticoagulants
* History of any previous ablation for atrial fibrillation
* Intracardiac thrombus
* Atrial fibrillation due to reversible cause
* Pregnancy
* Contraindication to stopping oral anticoagulation (for example as a result of a mechanical cardiac valve)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No