Atrial FibrillationCAMTAFNCT01411371
Catheter Ablation Versus Medical Treatment of AF in Heart Failure
A study testing Catheter ablation of persistent atrial fibrillation and Medical treatment alone in people with Atrial Fibrillation and Heart Failure, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Heart Failure
- What is being tested?
- Catheter ablation of persistent atrial fibrillation and Medical treatment alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2005to Feb 2013
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persistent atrial fibrillation
- Symptomatic heart failure
Who cannot join
- Reversible causes of heart failure
- Contraindications to catheter ablation
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Atrial Fibrillation, Heart Failure
- Being tested
- Catheter ablation of persistent atrial fibrillation, Medical treatment alone
- Keywords
- Atrial fibrillation, Heart failure, Catheter ablation
- Medical subject headings
- Atrial Fibrillation, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter ablation of persistent atrial fibrillationProcedure or surgery
Catheter ablation of AF as described previously by our group (e.g. Hunter et al, Heart 2010).
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).
| Study group | Role | What they receive |
|---|---|---|
| Catheter Ablation | Experimental | Catheter ablation of persistent atrial fibrillation to restore normal sinus rhythm. Receives: 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). Receives: Drug: Medical treatment alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Ejection Fraction Between Groups
Difference in left ventricular ejection fraction between groups on echocardiography at 6 months
Measured: 6 months
Secondary outcomes (6)
Difference in Peak VO2 Between Groups
Looking at peak volume oxygen updake between groups
Measured: 6 months
Difference in NYHA Class Between Groups
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.)
Measured: 6 months
Difference in BNP Between Groups
Difference in BNP between groups from 1 month onwards
Measured: 6 months
Difference in Quality of Life Between Groups
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)
Measured: 6 months
Reduction in End Systolic Volume
Comparisson between groups of the percentage reduction in left ventricular end systolic volume at 6 months compared to baseline.
Measured: 6 months compared to baseline
Difference in Heart Failure Symptoms
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)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2011 (estimated)
- Study startMar 2005
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- British Heart Foundation
- Responsible party
- Sponsor
- Investigators
- Richard J Schilling, MD FRCP, Principal investigator, Professor of Cardiology, Barts & The London NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01411371
- Sponsor's protocol ID
- 05/Q0605/47
- Acronym
- CAMTAF
- Status last verified
- Sep 2026
- First submitted
- 26 Jul 2010
- Last updated
- 21 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 24382410