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

Primary Purpose

Atrial Fibrillation, Heart Failure

Status

Unknown status

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Catheter ablation of persistent atrial fibrillation

Medical treatment alone

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Heart failure, Catheter ablation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Persistent atrial fibrillation
Symptomatic heart failure

Exclusion Criteria:

Reversible causes of heart failure
Contraindications to catheter ablation

Sites / Locations

Barts & The London NHS TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Catheter Ablation

Medical treatment alone

Arm Description

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

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).

Outcomes

Primary Outcome Measures

Difference in ejection fraction between groups

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

Secondary Outcome Measures

Difference in peak VO2 between groups

Difference in NYHA class between groups

Difference in BNP between groups

Difference in Quality of Life between groups

Using SF36 and Minnessota questionaire

Reduction in end systolic volume

Comparisson between groups of the percentage reduction in left ventricular end systolic volume at 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.

Full Information

NCT ID

NCT01411371

First Posted

July 26, 2010

Last Updated

August 5, 2011

Sponsor

Barts & The London NHS Trust

Collaborators

British Heart Foundation

1. Study Identification

Unique Protocol Identification Number

NCT01411371

Brief Title

Catheter Ablation Versus Medical Treatment of AF in Heart Failure

Acronym

CAMTAF

Official Title

Catheter Ablation Versus Medical Treatment of AF in Heart Failure

Study Type

Interventional

2. Study Status

Record Verification Date

May 2010

Overall Recruitment Status

Unknown status

Study Start Date

March 2005 (undefined)

Primary Completion Date

October 2011 (Anticipated)

Study Completion Date

October 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Barts & The London NHS Trust

Collaborators

British Heart Foundation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation, Heart Failure

Keywords

Atrial fibrillation, Heart failure, Catheter ablation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Catheter Ablation

Arm Type

Experimental

Arm Description

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

Arm Title

Medical treatment alone

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Catheter ablation of persistent atrial fibrillation

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Medical treatment alone

Intervention Description

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).

Primary Outcome Measure Information:

Title

Difference in ejection fraction between groups

Description

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

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Difference in peak VO2 between groups

Time Frame

6 months

Title

Difference in NYHA class between groups

Time Frame

6 months

Title

Difference in BNP between groups

Time Frame

6 months

Title

Difference in Quality of Life between groups

Description

Using SF36 and Minnessota questionaire

Time Frame

6 months

Title

Reduction in end systolic volume

Description

Comparisson between groups of the percentage reduction in left ventricular end systolic volume at 6 months compared to baseline.

Time Frame

6 months compared to baseline

Title

Difference in heart failure symptoms

Description

Comparisson between groups in heart failure symptoms using the Minessota living with heart failure questionaire.

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Persistent atrial fibrillation Symptomatic heart failure Exclusion Criteria: Reversible causes of heart failure Contraindications to catheter ablation

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ross J Hunter, MRCP

Phone

442076018639

ross.hunter@bartsandthelondon.nhs.uk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard J Schilling, MD FRCP

Organizational Affiliation

Professor of Cardiology, Barts & The London NHS Trust

Official's Role

Principal Investigator

Facility Information:

Facility Name

Barts & The London NHS Trust

City

London

State/Province

ZIP/Postal Code

EC1A 7BE

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ross J Hunter, MRCP

Phone

442076018639

ross.hunter@bartsandthelondon.nhs.uk

First Name & Middle Initial & Last Name & Degree

Richard J Schilling, MD FRCP

First Name & Middle Initial & Last Name & Degree

Ross J Hunter, MRCP

12. IPD Sharing Statement

Citations:

PubMed Identifier

24382410

Citation

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.

Results Reference

derived

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Catheter Ablation Versus Medical Treatment of AF in Heart Failure

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