Catheter Ablation Versus Medical Treatment of AF in Heart Failure

NCT ID: NCT01411371

Last Updated: 2011-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2011-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Catheter Ablation

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

Group Type EXPERIMENTAL

Catheter ablation of persistent atrial fibrillation

Intervention Type PROCEDURE

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

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).

Group Type ACTIVE_COMPARATOR

Medical treatment alone

Intervention Type 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).

Interventions

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Catheter ablation of persistent atrial fibrillation

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

Intervention Type PROCEDURE

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).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Persistent atrial fibrillation
* Symptomatic heart failure

Exclusion Criteria

* Reversible causes of heart failure
* Contraindications to catheter ablation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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British Heart Foundation

OTHER

Sponsor Role collaborator

Barts & The London NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Barts & The London NHS Trust

Principal Investigators

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Richard J Schilling, MD FRCP

Role: PRINCIPAL_INVESTIGATOR

Professor of Cardiology, Barts & The London NHS Trust

Locations

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Barts & The London NHS Trust

London, UK, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Ross J Hunter, MRCP

Role: CONTACT

442076018639

Facility Contacts

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Ross J Hunter, MRCP

Role: primary

442076018639

References

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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.

Reference Type DERIVED
PMID: 24382410 (View on PubMed)

Other Identifiers

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05/Q0605/47

Identifier Type: -

Identifier Source: org_study_id

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