Radiofrequency Catheter Ablation for Chronic Atrial Fibrillation

NCT ID: NCT00272636

Last Updated: 2015-06-03

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2005-02-28

Brief Summary

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

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Radiofrequency catheter ablation

Intervention Type PROCEDURE

Amiodarone and cardioversion

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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San Raffaele University Hospital, Italy

OTHER

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Principal Investigators

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Hakan Oral, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Fred Morady, MD

Role: STUDY_CHAIR

University of Michigan

Locations

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University of Michigan Health System

Ann Arbor, Michigan, United States

Site Status

San Raffaele Hospital

Milan, , Italy

Site Status

Countries

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United States Italy

Other Identifiers

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2002-0480

Identifier Type: -

Identifier Source: org_study_id

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