Catheter Ablation Versus Medical Rate Control for Atrial Fibrillation in Patients With Heart Failure (ARC-HF)
|ClinicalTrials.gov Identifier: NCT00878384|
Recruitment Status : Completed
First Posted : April 8, 2009
Last Update Posted : July 12, 2012
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation Heart Failure||Drug: Medication to control ventricular rate in AF Procedure: Catheter Ablation for Persistent Atrial Fibrillation||Not Applicable|
Currently available evidence suggests that occurrence of AF in patients with heart failure (HF) leads to a decline in exercise tolerance, worsened quality of life, increased hospitalisation, and in many studies an increase in mortality. These may be explained by the haemodynamic effects of AF i.e. reduction in functional cardiac output due to inappropriate heart rates, irregularity, and loss of atrial contraction, plus the risk of thromboembolism.
Evidence from large clinical studies has shown that patients with heart failure fare better if sinus rhythm can be restored, but on the contrary a 'rhythm control' strategy (as intention to treat) of cardioversion or antiarrhythmic drugs to achieve sinus rhythm has not been shown to be superior to the strategy of rate control. These apparently contradictory findings might be explained by the poor efficacy and side effects associated with current rhythm control strategies, or could reflect that AF is merely a passive marker of underlying disease severity. However, many studies would point to the former, and it might be hypothesised that the theoretical benefits of sinus rhythm could be seen for real in clinical practice if a superior rhythm-control strategy was used.
Catheter ablation, a relatively new treatment for atrial fibrillation, has been shown to be feasible in a non-randomised heart failure patient cohort, with markers suggesting improvement of cardiac function.
This prospective clinical trial will enrol HF patients on optimal therapy, with documented persistent AF, and compare the strategies of catheter-ablation and medical rate control in a 1:1 randomised fashion.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomised Trial to Assess Catheter Ablation Versus Rate-Control in the Management of Persistent Atrial Fibrillation in Chronic Heart Failure|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||July 2012|
Active Comparator: Rate control
Strategy of 'rate-control': acceptance of atrial fibrillation, and dose-adjusted drug therapy as needed to control ventricular rate.
Drug: Medication to control ventricular rate in AF
Standard pharmacologic rate control. Current therapy will be adjusted to achieve rate-control targets of <80bpm and <110bpm on exercise (6 minute walk). Where necessary, additional medication will be given as per standard practice (digoxin or beta-blocker). Typical does: Digoxin 62.5-250mcg o.d. ; Bisoprolol 1.25-20mg o.d.; Carvedilol 3.125-50mg b.d. ; Nebivolol 1.25-10mg o.d.
Active Comparator: Catheter Ablation
Strategy of 'rhythm control' by catheter ablation: patients will undergo catheter ablation with the intention of restoring sinus rhythm.
Procedure: Catheter Ablation for Persistent Atrial Fibrillation
Radiofrequency catheter ablation, which may include pulmonary vein isolation, atrial substrate modification, and/or linear ablation.
- Peak oxygen consumption at cardiopulmonary exercise test [ Time Frame: 12 months ]
- Left ventricular ejection fraction [ Time Frame: 12 months ]
- Quality of Life score [ Time Frame: 3, 6 and 12 months ]
- 6 minute walk distance [ Time Frame: 3, 6 and 12 months ]
- Level of plasma neurohormones (including BNP) [ Time Frame: 3, 6 and 12 months ]
- Freedom from AF [ Time Frame: 3, 6 and 12 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00878384
|Royal Brompton & Harefield NHS Trust|
|London, United Kingdom, SW3 6NP|
|Principal Investigator:||Tom Wong, MD FESC||Royal Brompton & Harefield NHS Foundation Trust|