NCT00238706

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Dec 2001

Typical duration for not_applicable atrial-fibrillation

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2001

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 13, 2005

Completed
Last Updated

May 5, 2006

Status Verified

October 1, 2005

First QC Date

October 12, 2005

Last Update Submit

May 4, 2006

Conditions

Atrial FibrillationRadiofrequency Catheter Ablation

Keywords

Radiofrequency catheter ablationAtrial fibrillationRandomized trial

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

  • 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).

Interventions

Radiofrequency ablationDEVICE

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients requiring MV surgery with at least 6 month history of atrial fibrillation

You may not qualify if:

  • Patients with sick sinus syndrome
  • Hyperthyroidism
  • Permanent pacemaker
  • Previous cardiac surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 16278360RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Nilesh Samani, FRCP

    University of Leicester, Dept of Cardiology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 12, 2005

First Posted

October 13, 2005

Study Start

December 1, 2001

Study Completion

November 1, 2004

Last Updated

May 5, 2006

Record last verified: 2005-10