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

This study has been completed.
Sponsor:
Collaborator:
British Heart Foundation
Information provided by:
University Hospitals, Leicester
ClinicalTrials.gov Identifier:
NCT00238706
First received: October 12, 2005
Last updated: May 4, 2006
Last verified: October 2005
  Purpose

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 Intervention
Atrial Fibrillation
Radiofrequency Catheter Ablation
Device: Radiofrequency ablation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Left Atrial Radiofrequency Ablation During Mitral Valve Surgery for Continuous Atrial Fibrillation: A Prospective Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by University Hospitals, Leicester:

Primary Outcome Measures:
  • The primary outcome endpoint was the presence of SR at 12 months

Secondary Outcome Measures:
  • Secondary endpoints included:
  • patient functional status and exercise capacity
  • Left atrial contractility
  • Left atrial and left ventricular dimension and function Plasma levels of B-Type natriuretic peptide (BNP).

Study Start Date: December 2001
Estimated Study Completion Date: November 2004
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).

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00238706

Sponsors and Collaborators
University Hospitals, Leicester
British Heart Foundation
Investigators
Study Director: Nilesh Samani, FRCP University of Leicester, Dept of Cardiology
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00238706     History of Changes
Other Study ID Numbers: BHF PG/2001096
Study First Received: October 12, 2005
Last Updated: May 4, 2006
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University Hospitals, Leicester:
Radiofrequency catheter ablation
Atrial fibrillation
Randomized trial

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014