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

Atrial Fibrillation Clinical Trial

Official title:

Left Atrial Radiofrequency Ablation During Mitral Valve Surgery for Continuous Atrial Fibrillation: A Prospective Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00238706
• Other study ID #: BHF PG/2001096
• Status: Completed
• Phase: N/A
• First received: October 12, 2005
• Last updated: May 4, 2006
• Start date: December 2001
• Est. completion date: November 2004

Study information

• Verified date: October 2005
• Source: University Hospitals, Leicester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Radiofrequency Catheter Ablation

Intervention

Device:
• Radiofrequency ablation

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Hospitals, Leicester	British Heart Foundation

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome endpoint was the presence of SR at 12 months
Secondary	Secondary endpoints included:
Secondary	patient functional status and exercise capacity
Secondary	Left atrial contractility
Secondary	Left atrial and left ventricular dimension and function Plasma levels of B-Type natriuretic peptide (BNP).