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

• Sponsor: University Hospitals, Leicester (Other)
• Overall Status: Completed
• CT.gov ID: NCT00238706
• Collaborator: British Heart Foundation (Other)
• Duration (Months): 35

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation; Radiofrequency Catheter Ablation	Device: Radiofrequency ablation	N/A

Detailed Description

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).

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single
• Primary Purpose: Treatment
• Official Title: Left Atrial Radiofrequency Ablation During Mitral Valve Surgery for Continuous Atrial Fibrillation: A Prospective Randomized Clinical Trial
• Study Start Date: Dec 1, 2001
• Study Completion Date: Nov 1, 2004

Outcome Measures

Primary Outcome Measures

1. The primary outcome endpoint was the presence of SR at 12 months []

Secondary Outcome Measures

1. Secondary endpoints included: []

2. patient functional status and exercise capacity []

3. Left atrial contractility []

4. Left atrial and left ventricular dimension and function Plasma levels of B-Type natriuretic peptide (BNP). []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 0 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University Hospitals, Leicester
• British Heart Foundation

Investigators

• Study Director: Nilesh Samani, FRCP, University of Leicester, Dept of Cardiology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00238706
• Other Study ID Numbers: BHF PG/2001096
• First Posted: Oct 13, 2005
• Last Update Posted: May 5, 2006
• Last Verified: Oct 1, 2005

• Keywords provided by , ,: Radiofrequency catheter ablation; Atrial fibrillation; Randomized trial
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

No Results Posted as of May 5, 2006