Clinical trial NCT00238706: 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
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Radiofrequency Catheter Ablation
Keywords: Radiofrequency catheter ablation
Atrial fibrillation
Randomized trial
Lead sponsor: University Hospitals, Leicester
Sponsor class: OTHER
Collaborators: name: British Heart Foundation
First posted: 2005-10-13
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: The primary outcome endpoint was the presence of SR at 12 months
Secondary outcomes:
measure: Secondary endpoints included:
measure: patient functional status and exercise capacity
measure: Left atrial contractility
measure: Left atrial and left ventricular dimension and function Plasma levels of B-Type natriuretic peptide (BNP).
Other outcomes:
Locations:
Study officials:
affiliation: University of Leicester, Dept of Cardiology
name: Nilesh Samani, FRCP
role: STUDY_DIRECTOR
References:
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.