Catheter Ablation Versus Medical Treatment of AF in Heart Failure (CAMTAF)

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.

Study Overview

• Status: Unknown
• Conditions: Heart Failure; Atrial Fibrillation
• Intervention / Treatment: Procedure: Catheter ablation of persistent atrial fibrillation; Drug: Medical treatment alone

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ross J Hunter, MRCP; Phone Number: 442076018639; Email: ross.hunter@bartsandthelondon.nhs.uk

Study Locations

• United Kingdom
  • UK
    • London, UK, United Kingdom, EC1A 7BE
      • Recruiting
      • Barts & The London NHS Trust
      • Contact: Ross J Hunter, MRCP; Phone Number: 442076018639; Email: ross.hunter@bartsandthelondon.nhs.uk
      • Principal Investigator: Richard J Schilling, MD FRCP
      • Sub-Investigator: Ross J Hunter, MRCP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Persistent atrial fibrillation
• Symptomatic heart failure

Exclusion Criteria:

• Reversible causes of heart failure
• Contraindications to catheter ablation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Catheter Ablation; Catheter ablation of persistent atrial fibrillation to restore normal sinus rhythm.	Procedure: Catheter ablation of persistent atrial fibrillation; Catheter ablation of AF as described previously by our group (e.g. Hunter et al, Heart 2010).
Active Comparator: Medical treatment alone; 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; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in ejection fraction between groups	Difference in left ventricular ejection fraction between groups on echocardiography at 6 months	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Using SF36 and Minnessota questionaire	6 months
Reduction in end systolic volume	Comparisson between groups of the percentage reduction in left ventricular end systolic volume at 6 months compared to baseline.	6 months compared to baseline
Difference in heart failure symptoms	Comparisson between groups in heart failure symptoms using the Minessota living with heart failure questionaire.	6 months

Collaborators and Investigators

• Sponsor: Barts & The London NHS Trust
• Collaborators: British Heart Foundation
• Investigators: Principal Investigator: Richard J Schilling, MD FRCP, Professor of Cardiology, Barts & The London NHS Trust

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2005
• Primary Completion (Anticipated): October 1, 2011
• Study Completion (Anticipated): October 1, 2011

Study Registration Dates

• First Submitted: July 26, 2010
• First Submitted That Met QC Criteria: August 5, 2011
• First Posted (Estimate): August 8, 2011

Study Record Updates

• Last Update Posted (Estimate): August 8, 2011
• Last Update Submitted That Met QC Criteria: August 5, 2011
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: Atrial fibrillation; Heart failure; Catheter ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Failure; Atrial Fibrillation
• Other Study ID Numbers: 05/Q0605/47

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No