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

July 11, 2012 updated by: Royal Brompton & Harefield NHS Foundation Trust

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SW3 6NP
        • Royal Brompton & Harefield NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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:
  • AF ablation
  • Radiofrequency catheter ablation
  • LA maze

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Peak oxygen consumption at cardiopulmonary exercise test
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Left ventricular ejection fraction
Time Frame: 12 months
12 months
Quality of Life score
Time Frame: 3, 6 and 12 months
3, 6 and 12 months
6 minute walk distance
Time Frame: 3, 6 and 12 months
3, 6 and 12 months
Level of plasma neurohormones (including BNP)
Time Frame: 3, 6 and 12 months
3, 6 and 12 months
Freedom from AF
Time Frame: 3, 6 and 12 months
3, 6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Brompton & Harefield NHS Foundation Trust

Investigators

  • Principal Investigator: Tom Wong, MD FESC, Royal Brompton & Harefield NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

April 7, 2009

First Submitted That Met QC Criteria

April 7, 2009

First Posted (Estimate)

April 8, 2009

Study Record Updates

Last Update Posted (Estimate)

July 12, 2012

Last Update Submitted That Met QC Criteria

July 11, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008CI008B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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