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

Primary Purpose

Atrial Fibrillation, Radiofrequency Catheter Ablation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Radiofrequency ablation
Sponsored by
University Hospitals, Leicester
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Radiofrequency catheter ablation, Atrial fibrillation, Randomized trial

Eligibility Criteria

0 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    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).

    Full Information

    First Posted
    October 12, 2005
    Last Updated
    May 4, 2006
    Sponsor
    University Hospitals, Leicester
    Collaborators
    British Heart Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00238706
    Brief Title
    Use of Radiofrequency Ablation to Eliminate Continuous Atrial Fibrillation in Patients Undergoing Mitral Valve Surgery
    Official Title
    Left Atrial Radiofrequency Ablation During Mitral Valve Surgery for Continuous Atrial Fibrillation: A Prospective Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2005
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2001 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    November 2004 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University Hospitals, Leicester
    Collaborators
    British Heart Foundation

    4. Oversight

    5. 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.
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atrial Fibrillation, Radiofrequency Catheter Ablation
    Keywords
    Radiofrequency catheter ablation, Atrial fibrillation, Randomized trial

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Single
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    Radiofrequency ablation
    Primary Outcome Measure Information:
    Title
    The primary outcome endpoint was the presence of SR at 12 months
    Secondary Outcome Measure Information:
    Title
    Secondary endpoints included:
    Title
    patient functional status and exercise capacity
    Title
    Left atrial contractility
    Title
    Left atrial and left ventricular dimension and function Plasma levels of B-Type natriuretic peptide (BNP).

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    0 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nilesh Samani, FRCP
    Organizational Affiliation
    University of Leicester, Dept of Cardiology
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16278360
    Citation
    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.
    Results Reference
    result

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

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