- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01411371
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
UK
-
London, UK, United Kingdom, EC1A 7BE
- Barts & The London NHS Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Catheter Ablation
Catheter ablation of persistent atrial fibrillation to restore normal sinus rhythm. |
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). |
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
Time Frame: 6 months
|
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
Time Frame: 6 months
|
Looking at peak volume oxygen updake between groups |
6 months
|
|
Difference in NYHA Class Between Groups
Time Frame: 6 months
|
NYHA Functional Classification. classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity; the limitations/symptoms are in regards to normal breathing and varying degrees in shortness of breath and or angina pain (Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).Comfortable only at rest. Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients. No NYHA class listed or unable to determine.) |
6 months
|
|
Difference in BNP Between Groups
Time Frame: 6 months
|
Difference in BNP between groups from 1 month onwards |
6 months
|
|
Difference in Quality of Life Between Groups
Time Frame: 6 months
|
Assessed from 1 month onwards. Using SF36 (total score indicating a range of low to high Quality of life) and Minnessota questionaire (Minnesota Living With Heart Failure Questionnaire (MLHFQ) uses a scale from 0 to 105, where higher scores indicate poorer health-related quality of life) |
6 months
|
|
Reduction in End Systolic Volume
Time Frame: 6 months compared to baseline
|
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
Time Frame: 6 months
|
Comparison between groups in heart failure symptoms using The Minnesota Living with Heart Failure Questionnaire (health related quality of life- 0 to 105. Lower scores mean a better quality of life; higher scores mean worse limitations) |
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Richard J Schilling, MD FRCP, Professor of Cardiology, Barts & The London NHS Trust
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05/Q0605/47
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