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COMPLETED
NCT01420393
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Rhythm Control - Catheter Ablation With or Without Anti-arrhythmic Drug Control of Maintaining Sinus Rhythm Versus Rate Control With Medical Therapy and/or Atrio-ventricular Junction Ablation and Pacemaker Treatment for Atrial Fibrillation

Sponsor: Ottawa Heart Institute Research Corporation

View on ClinicalTrials.gov

Summary

Atrial fibrillation and heart failure are two common heart conditions that are associated with an increase in death and suffering. When both of these two conditions occur in a patient the patient's prognosis is poor. These patients have poor life quality and are frequently admitted to the hospital. The treatment of atrial fibrillation in heart failure patients is extremely challenging. Two options for managing the atrial fibrillation are permitting the atrial fibrillation to continue but controlling the heart rate, or to convert the atrial fibrillation rhythm back to normal and try to maintain the heart in sinus rhythm. Until now, the method to keep the patient in normal sinus rhythm is with antiarrhythmic drugs. Studies using antiarrhythmic drugs to control the rhythm failed to show any survival benefit when compared with permitting the patient to be in atrial fibrillation. In the last few years, new development in techniques and technologies now enable catheter ablation (cauterization of tissue in the heart with a catheter) to be a successful treatment in abolishing atrial fibrillation and that this approach is better than antiarrhythmic drug to control the rhythm. However, there has not been any long-term study to determine whether catheter ablation to abolish atrial fibrillation in heart failure patients would reduce mortality or admissions for heart failure. This study is to compare the effect of catheter ablation-based atrial fibrillation rhythm control to rate control in patients with heart failure and high burden atrial fibrillation on the composite endpoint of all-cause mortality and heart failure events defined as an admission to a healthcare facility for \> 24 hours or clinically significant worsening heart failure leading to an intervention (defined as treatment in an emergency department, a same-day access clinic, or an infusion centre) or unscheduled visits to a healthcare provider for administration of an intravenous diuretic and an increase in chronic heart failure therapy. This study may have a dramatic impact on the way the investigators manage these patients with atrial fibrillation and heart failure and may improve the outlook and well being of these patients.

Official title: A Randomized Ablation-based Atrial Fibrillation Rhythm Control Versus Rate Control Trial in Patients With Heart Failure and High Burden Atrial Fibrillation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

411

Start Date

2011-09

Completion Date

2021-06

Last Updated

2026-05-11

Healthy Volunteers

No

Interventions

PROCEDURE

Rhythm control

Patients randomized to catheter ablation-based AF rhythm control group will receive optimal HF therapy and one or more aggressive catheter ablation, which include PV antral ablation and LA substrate ablation with or without adjunctive antiarrhythmic drug

OTHER

Rate Control

Patients in the rate control group will receive optimal HF therapy and rate control measures to achieve a resting HR \< 80 bpm and 6-minute walk HR \< 110 bpm.

Locations (21)

Instituto de Cardiologia-FUC RS

Porto Alegre, Rio Grande do Sul, Brazil

Libin Cardiovascular Institute of Alberta, Calgary

Calgary, Alberta, Canada

Royal Alexandra Hospital

Edmonton, Alberta, Canada

Vancouver General

Vancouver, British Columbia, Canada

Royal Jubilee Hospital

Victoria, British Columbia, Canada

Queen Elizabeth II Health Science

Halifax, Nova Scotia, Canada

Hamilton Health Sciences Centre

Hamilton, Ontario, Canada

Kingston General Hospital

Kingston, Ontario, Canada

St. Mary's General Hospital

Kitchener, Ontario, Canada

London Health Sciences Centre

London, Ontario, Canada

Southlake Regional Health Care

Newmarket, Ontario, Canada

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Toronto General Hospital, University Health Network

Toronto, Ontario, Canada

Institute de Cardiologie de Montréal

Montreal, Quebec, Canada

CHUM Centre hospitalier universitaire de Montréal

Montreal, Quebec, Canada

McGill University Health Centre

Montreal, Quebec, Canada

Insitut universitaire de cardiologie and pneumologie de Quebec

Québec, Quebec, Canada

CHUS Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Karolinska University Hospital

Stockholm, Sweden

National Taiwan University Hospital

Taipei, Taiwan