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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00238706
Enrollment
Unknown
Registered
2005-10-13
Start date
2001-12-31
Completion date
2004-11-30
Last updated
2006-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Radiofrequency Catheter Ablation

Keywords

Radiofrequency catheter ablation, Atrial fibrillation, Randomized trial

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).

Interventions

DEVICERadiofrequency ablation

Sponsors

British Heart Foundation
CollaboratorOTHER
University Hospitals, Leicester
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
0 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The primary outcome endpoint was the presence of SR at 12 months

Secondary

MeasureTime frame
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).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 12, 2026