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
  Purpose

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.


Condition Intervention
Atrial Fibrillation
Heart Failure
Drug: Medication to control ventricular rate in AF
Procedure: Catheter Ablation for Persistent Atrial Fibrillation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised Trial to Assess Catheter Ablation Versus Rate-Control in the Management of Persistent Atrial Fibrillation in Chronic Heart Failure

Resource links provided by NLM:


Further study details as provided by Royal Brompton & Harefield NHS Foundation Trust:

Primary Outcome Measures:
  • Peak oxygen consumption at cardiopulmonary exercise test [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 52
Study Start Date: April 2009
Study Completion Date: July 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Names:
  • Radiofrequency catheter ablation
  • AF ablation
  • LA maze

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  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: NCT00878384

Locations
United Kingdom
Royal Brompton & Harefield NHS Trust
London, United Kingdom, SW3 6NP
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
Investigators
Principal Investigator: Tom Wong, MD FESC Royal Brompton & Harefield NHS Foundation Trust
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00878384     History of Changes
Other Study ID Numbers: 2008CI008B
Study First Received: April 7, 2009
Last Updated: July 11, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Royal Brompton & Harefield NHS Foundation Trust:
Atrial Fibrillation
Heart Failure
Heart Rate Control
Catheter Ablation

Additional relevant MeSH terms:
Atrial Fibrillation
Heart Failure
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014