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OpenTrials
Completed

NCT Number: NCT00238706

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

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.

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Key information

Age range

0 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiofrequency Ablation

Device

Primary outcomes

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

Secondary outcomes

  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).

Sponsors and collaborators

Lead sponsor

University Hospitals, Leicester

Other

Collaborators

  • British Heart Foundation

Registry information

Official study title

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

Important dates

Study start
2001
Study completion
2004
First posted
Oct 13, 2005
Registry last updated
May 5, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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