Use of Radiofrequency Ablation to Eliminate Continuous Atrial Fibrillation in Patients Undergoing Mitral Valve Surgery

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

Study Classification

INTERVENTIONAL

Study Start Date

2001-12-31

Study Completion Date

2004-11-30

Brief Summary

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The aim of this prospective randomized clinical trial was to evaluate the early and late outcome following left atrial radiofrequency ablation during MV surgery for the treatment of continuous atrial fibrillation and to assess the functional effects of restoration of sinus rhythm.

Detailed Description

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Atrial fibrillation (AF) is a frequent and important contributor to symptoms and morbidity in patients with mitral valve (MV) disease.Radiofrequency ablation (RFA) of the left atrium (LA) during open- heart surgery has emerged as a novel surgical modality for the treatment of AF. Although RFA therapy of the LA is being increasingly offered to patients with chronic AF undergoing MV surgery, its efficacy has not been tested in the context of an adequately powered randomized study. The aim of this prospective randomized clinical trial was to evaluate the early and late outcome following left atrial RFA during MV surgery for the treatment of continuous AF and to assess the functional effects of restoration of SR.

Patients were randomized to undergo MV surgery or MV surgery plus RFA of the LA. Additional cardiac procedures were performed as required.

The primary outcome endpoint was the presence of SR at 12 months. Secondary endpoints included patient functional status and exercise capacity, LA contractility, and LA and left ventricular (LV) dimension and function and plasma levels of B-Type natriuretic peptide (BNP).

Conditions

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Atrial Fibrillation Radiofrequency Catheter Ablation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Radiofrequency ablation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients requiring MV surgery with at least 6 month history of atrial fibrillation

Exclusion Criteria

* Patients with sick sinus syndrome
* Hyperthyroidism
* Permanent pacemaker
* Previous cardiac surgery

Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Nilesh Samani, FRCP

Role: STUDY_DIRECTOR

University of Leicester, Dept of Cardiology

References

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Doukas G, Samani NJ, Alexiou C, Oc M, Chin DT, Stafford PG, Ng LL, Spyt TJ. Left atrial radiofrequency ablation during mitral valve surgery for continuous atrial fibrillation: a randomized controlled trial. JAMA. 2005 Nov 9;294(18):2323-9. doi: 10.1001/jama.294.18.2323.

Reference Type RESULT

PMID: 16278360 (View on PubMed)

Other Identifiers

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BHF PG/2001096

Identifier Type: -

Identifier Source: org_study_id