NCT01411371

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable atrial-fibrillation

Timeline
Completed

Started Mar 2005

Longer than P75 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2005

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2010

Completed
1 year until next milestone

First Posted

Study publicly available on registry

August 8, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

August 8, 2011

Status Verified

May 1, 2010

Enrollment Period

6.6 years

First QC Date

July 26, 2010

Last Update Submit

August 5, 2011

Conditions

Atrial FibrillationHeart Failure

Keywords

Atrial fibrillationHeart failureCatheter 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

  • +1 more secondary outcomes

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 fibrillationPROCEDURE

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

Catheter Ablation
Medical treatment aloneDRUG

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barts & The London NHS Trust

London, UK, EC1A 7BE, United Kingdom

RECRUITING

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: 24382410DERIVED

MeSH Terms

Conditions

Atrial FibrillationHeart Failure

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Richard J Schilling, MD FRCP

    Professor of Cardiology, Barts & The London NHS Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ross J Hunter, MRCP

CONTACT

442076018639ross.hunter@bartsandthelondon.nhs.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 26, 2010

First Posted

August 8, 2011

Study Start

March 1, 2005

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

August 8, 2011

Record last verified: 2010-05

Locations

GB(1)