Catheter Ablation Versus Medical Rate Control for Atrial Fibrillation in Patients With Heart Failure (ARC-HF)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00878384
First received: April 7, 2009
Last updated: July 11, 2012
Last verified: July 2012

April 7, 2009
July 11, 2012
April 2009
June 2012   (final data collection date for primary outcome measure)
Peak oxygen consumption at cardiopulmonary exercise test [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00878384 on ClinicalTrials.gov Archive Site
  • Left ventricular ejection fraction [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Quality of Life score [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
  • 6 minute walk distance [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
  • Level of plasma neurohormones (including BNP) [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
  • Freedom from AF [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Catheter Ablation Versus Medical Rate Control for Atrial Fibrillation in Patients With Heart Failure
A Randomised Trial to Assess Catheter Ablation Versus Rate-Control in the Management of Persistent Atrial Fibrillation in Chronic Heart Failure

It is still uncertain what the best treatment is for patients who have both atrial fibrillation (AF) and heart failure. The aim of the study is to help identify the optimal treatment for patients with these two significant medical conditions. This will be performed by comparing two alternative strategies for AF management: catheter ablation (to restore normal rhythm) and medical therapy (to control heart rate, but not aiming ro restore normal rhythm). After random assignment, the effect of each strategy will be assessed by looking for changes in exercise capacity, symptoms, heart pump function, and quality of life during 12 months of follow-up.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Atrial Fibrillation
  • Heart Failure
  • 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.
  • Procedure: Catheter Ablation for Persistent Atrial Fibrillation
    Radiofrequency catheter ablation, which may include pulmonary vein isolation, atrial substrate modification, and/or linear ablation.
    Other Names:
    • Radiofrequency catheter ablation
    • AF ablation
    • LA maze
  • Active Comparator: Rate control
    Strategy of 'rate-control': acceptance of atrial fibrillation, and dose-adjusted drug therapy as needed to control ventricular rate.
    Intervention: Drug: Medication to control ventricular rate in AF
  • Active Comparator: Catheter Ablation
    Strategy of 'rhythm control' by catheter ablation: patients will undergo catheter ablation with the intention of restoring sinus rhythm.
    Intervention: Procedure: Catheter Ablation for Persistent Atrial Fibrillation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
July 2012
June 2012   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Age ≥ 18 years, < 80years
  • NYHA II-IV symptoms
  • Impairment of left ventricular systolic function (left ventricular ejection fraction estimated as ≤ 35% by radionuclide ventriculography)
  • Documented AF lasting for at least 7 days (persistent or permanent AF)

Exclusion criteria:

  • CRT or ICD device implanted in the previous 6 months
  • AV nodal ablation within previous 3 months
  • Prior AV nodal ablation or complete heart block with a single chamber pacemaker
  • Contraindication to anticoagulation
  • Persistent thrombus in the left atrium despite anticoagulation
  • Active malignancy
  • Cerebrovascular accident within the previous 6 months
  • Reversible causes of AF including thyroid disorders, alcohol, recent surgery
  • Reversible causes of heart failure including acute myocarditis or alcohol
  • Cardiac events including myocardial infarction (MI), percutaneous coronary intervention (PCI), valve or coronary bypass surgery within the previous 3 months
  • Prior AF ablation procedure
  • Previous heart transplant, or on urgent heart transplant waiting list
  • Severe neuro-muscular disease
  • Creatinine clearance <30 ml/min
  • Serum bilirubin >50 micromol/L
  • Active participation in another research study
  • Unable to understand and comply with protocol or give written informed consent
  • Body mass index >35 (kg/m2)
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00878384
2008CI008B
Yes
Royal Brompton & Harefield NHS Foundation Trust
Royal Brompton & Harefield NHS Foundation Trust
Not Provided
Principal Investigator: Tom Wong, MD FESC Royal Brompton & Harefield NHS Foundation Trust
Royal Brompton & Harefield NHS Foundation Trust
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP