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Completed

NCT Number: NCT00272636

Radiofrequency Catheter Ablation for Chronic Atrial Fibrillation

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

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Raffaele Hospital, Milan, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

radiofrequency catheter ablation

Procedure

Amiodarone and cardioversion

Drug

Primary outcomes

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

Secondary outcomes

  1. incidence of complications

  2. changes in left atrial diameter

  3. changes in left ventricular ejection fraction

  4. changes in symptom severity

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • San Raffaele University Hospital, Italy

Registry information

Official study title

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

Important dates

Study start
2002
Study completion
2005
First posted
Jan 6, 2006
Registry last updated
Jun 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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