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

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NHS Trust

Status

Completed

Conditions

Atrial Fibrillation
Radiofrequency Catheter Ablation

Treatments

Device: Radiofrequency ablation

Study type

Interventional

Funder types

Other

Identifiers

NCT00238706
BHF PG/2001096

Details and patient eligibility

About

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.

Full 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).

Sex

All

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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