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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Barts & The London NHS Trust.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
British Heart Foundation
Information provided by:
Barts & The London NHS Trust
ClinicalTrials.gov Identifier:
NCT01411371
First received: July 26, 2010
Last updated: August 5, 2011
Last verified: May 2010
  Purpose

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.


Condition Intervention
Atrial Fibrillation
Heart Failure
Procedure: Catheter ablation of persistent atrial fibrillation
Drug: Medical treatment alone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Catheter Ablation Versus Medical Treatment of AF in Heart Failure

Resource links provided by NLM:


Further study details as provided by Barts & The London NHS Trust:

Primary Outcome Measures:
  • Difference in ejection fraction between groups [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Difference in left ventricular ejection fraction between groups on echocardiography at 6 months


Secondary Outcome Measures:
  • Difference in peak VO2 between groups [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Difference in NYHA class between groups [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Difference in BNP between groups [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Difference in Quality of Life between groups [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Using SF36 and Minnessota questionaire

  • Reduction in end systolic volume [ Time Frame: 6 months compared to baseline ] [ Designated as safety issue: No ]
    Comparisson between groups of the percentage reduction in left ventricular end systolic volume at 6 months compared to baseline.

  • Difference in heart failure symptoms [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Comparisson between groups in heart failure symptoms using the Minessota living with heart failure questionaire.


Estimated Enrollment: 60
Study Start Date: March 2005
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Persistent atrial fibrillation
  • Symptomatic heart failure

Exclusion Criteria:

  • Reversible causes of heart failure
  • Contraindications to catheter ablation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01411371

Contacts
Contact: Ross J Hunter, MRCP 442076018639 ross.hunter@bartsandthelondon.nhs.uk

Locations
United Kingdom
Barts & The London NHS Trust Recruiting
London, UK, United Kingdom, EC1A 7BE
Contact: Ross J Hunter, MRCP    442076018639    ross.hunter@bartsandthelondon.nhs.uk   
Principal Investigator: Richard J Schilling, MD FRCP         
Sub-Investigator: Ross J Hunter, MRCP         
Sponsors and Collaborators
Barts & The London NHS Trust
British Heart Foundation
Investigators
Principal Investigator: Richard J Schilling, MD FRCP Professor of Cardiology, Barts & The London NHS Trust
  More Information

Additional Information:
No publications provided by Barts & The London NHS Trust

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Professor Richard Schilling, Barts & The London NHS Trust
ClinicalTrials.gov Identifier: NCT01411371     History of Changes
Other Study ID Numbers: 05/Q0605/47
Study First Received: July 26, 2010
Last Updated: August 5, 2011
Health Authority: United Kingdon: National Health Service

Keywords provided by Barts & The London NHS Trust:
Atrial fibrillation
Heart failure
Catheter ablation

Additional relevant MeSH terms:
Heart Failure
Atrial Fibrillation
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes
Calcium Channel Blockers
Angiotensin-Converting Enzyme Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on October 01, 2014