Catheter Ablation Versus Medical Treatment of AF in Heart Failure

NCT01411371 | Completed Results

• 1 other identifier: 05/Q0605/47
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Heart failure and atrial fibrillation (AF) often coexist, and each increases the morbidity and mortality associated with the other. The investigators hypothesized that restoration of normal sinus rhythm by catheter ablation is superior to medical treatment of AF in heart failure. This study randomizes patients with heart failure and persistent AF to medical treatment of AF or catheter ablation to restore sinus rhythm.

Conditions

Atrial Fibrillation; Heart Failure

Keywords

Atrial fibrillation; Heart failure; Catheter ablation

Outcome Measures

Primary Outcomes (1)

• Difference in Ejection Fraction Between Groups

  Difference in left ventricular ejection fraction between groups on echocardiography at 6 months

  6 months

Secondary Outcomes (6)

• Difference in Peak VO2 Between Groups

  6 months

• Difference in NYHA Class Between Groups

  6 months

• Difference in BNP Between Groups

  6 months

• Difference in Quality of Life Between Groups

  6 months

• Reduction in End Systolic Volume

  6 months compared to baseline

Study Arms (2)

Catheter Ablation

EXPERIMENTAL

Catheter ablation of persistent atrial fibrillation to restore normal sinus rhythm.

Procedure: Catheter ablation of persistent atrial fibrillation

Medical treatment alone

ACTIVE COMPARATOR

Patients are randomised to medical treatment alone for atrial fibrillation. Treatment will be as per current guidelines for persistent atrial fibrillation, with rate control as first line (using beta-blockers, calcium channel blockers and digoxin as indicated) and rhythm control as second line (using sotalol, dronedarone, or amiodarone as indicated). (Both groups will receive standard heart failure medication including angiotensin converting enzyme inhibitors, beta blockers, aldosterone antagonists, and diuretics as indicated).

Drug: Medical treatment alone

Interventions

Catheter ablation of persistent atrial fibrillation PROCEDURE

Catheter ablation of AF as described previously by our group (e.g. Hunter et al, Heart 2010).

Catheter Ablation

Medical treatment alone DRUG

Medical treatment of persistent AF as 'normal care'. Patients are randomised to medical treatment alone for atrial fibrillation. Treatment will be as per current guidelines for persistent atrial fibrillation, with rate control as first line (using beta-blockers, calcium channel blockers and digoxin as indicated) and rhythm control as second line (using sotalol, dronedarone, or amiodarone as indicated). (Both groups will receive standard heart failure medication including angiotensin converting enzyme inhibitors, beta blockers, aldosterone antagonists, and diuretics as indicated).

Medical treatment alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Persistent atrial fibrillation
• Symptomatic heart failure

You may not qualify if:

• Reversible causes of heart failure
• Contraindications to catheter ablation

Sponsors & Collaborators

• Barts & The London NHS Trust: lead
• British Heart Foundation: collaborator

Study Sites (1)

Barts & The London NHS Trust

London, UK, EC1A 7BE, United Kingdom

Location

Related Publications (1)

• Hunter RJ, Berriman TJ, Diab I, Kamdar R, Richmond L, Baker V, Goromonzi F, Sawhney V, Duncan E, Page SP, Ullah W, Unsworth B, Mayet J, Dhinoja M, Earley MJ, Sporton S, Schilling RJ. A randomized controlled trial of catheter ablation versus medical treatment of atrial fibrillation in heart failure (the CAMTAF trial). Circ Arrhythm Electrophysiol. 2014 Feb;7(1):31-8. doi: 10.1161/CIRCEP.113.000806. Epub 2014 Jan 1.

  PMID: 24382410 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Heart Failure

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Large scale randomized controlled trials are underway to determine whether catheter ablation of AF in heart failure might impact on hard end points such as heart failure admissions or mortality, and to examine cost-effectiveness.

Results Point of Contact

• Title: Dr Ross Hunter
• Organization: The Barts Heart Centre, St Bartholomew's Hospital, Barts Health NHS Trust

ross.hunter@bartshealth.nhs.uk

+442034655398

Study Officials

• Richard J Schilling, MD FRCP

  Professor of Cardiology, Barts & The London NHS Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2010
• First Posted: August 8, 2011
• Study Start: March 1, 2005
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: September 21, 2026
• Results First Posted: September 21, 2026

Record last verified: 2026-09

Locations

GB (1)