Radiofrequency Catheter Ablation for Chronic Atrial Fibrillation

Randomized Comparison of Radiofrequency Catheter Ablation vs. Antiarrhythmic Therapy With Amiodarone for Maintaining Sinus Rhythm in Patients With Chronic Atrial Fibrillation

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00272636

Enrollment

140

Registered

2006-01-06

Start date

2002-11-30

Completion date

2005-02-28

Last updated

2015-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation, catheter ablation, amiodarone, cardioversion

Brief summary

The purpose of this study is to determine the long-term efficacy of radiofrequency catheter ablation in patients with chronic atrial fibrillation.

Interventions

PROCEDURERadiofrequency catheter ablation

DRUGAmiodarone and cardioversion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Chronic atrial fibrillation

Exclusion criteria

* Left atrial diameter \>55 mm * Left ventricular ejection fraction \<0.30 * Contraindication to amiodarone therapy or anticoagulation with warfarin * Presence of a mechanical prosthetic valve * History of a cerebrovascular accident * Presence of left atrial thrombus on TEE * Prior attempt at catheter or surgical ablation for atrial fibrillation

Design outcomes

Primary

Measure	Time frame
Freedom from atrial fibrillation and atrial flutter in the absence of antiarrhythmic drug therapy at 1 year.	—

Secondary

Measure	Time frame
incidence of complications	—
changes in left atrial diameter	—
changes in left ventricular ejection fraction	—
changes in symptom severity	—

Countries

Italy, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026