Resynchronization/Defibrillation for Ambulatory Heart Failure Trial in Patients With Permanent Atrial Fibrillation

NCT01994252 | Completed DMC

• 1 other identifier: RN00208414
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 15

Brief Summary

Atrial fibrillation (AF) and heart failure (HF) are two common heart conditions that are encountered with an increase in death and suffering. When both these two conditions occur in a patient, the patient's prognosis is poor with a reduced quality of life and impaired heart function. These patients have enlarged hearts, specifically the left ventricle (major pumping chamber), which impairs the heart's pumping capacity, leading to symptoms such as fatigue, shortness of breath from any type of exertion, and swelling, usually of the feet and ankles. In these HF patients who are in AF all of the time, who would otherwise be a suitable candidate for an implantable defibrillator to prevent sudden cardiac death, we would like to determine whether adding pacing of both ventricles will reduce heart size (left ventricular end systolic volume index LVESVi) as measured by ultrasound, which can improve its function and help the heart pump more efficiently. Other studies have shown that adding pacing to both ventricles is of benefit in HF patients with mild to moderate symptoms and have a regular heart rhythm. The Investigators now want to explore if this therapy will benefit those patients with a permanent irregular heart rhythm (AF).

Conditions

Heart Disease; Congestive Heart Failure; Atrial Fibrillation

Keywords

defibrillator; cardiac resynchronization

Outcome Measures

Primary Outcomes (4)

• The primary outcome is a hierarchy (winratio) of 1) all-cause mortality

  Mortality data will be collected for the duration of the study

  12 months

• The primary outcome is a hierarchy (winratio) of 2) Heart Failure Events (>24 Hours admission for Heart Failure or clinically worsening Heart Failure leading to IV diuretics administered

  HF events (\> 24 hour admit or \< 24 hr with IV diuretics) will be collected for the duration of the study

  12 months

• The primary outcome is a hierarchy (winratio) of 3) Left ventricular ejection fraction

  Change in echocardiogram parameters LVEF measure

  baseline to 12 months

• The primary outcome is a hierarchy (winratio) of 4) QoL - Minnesota Living with Heart Failure Questionnaire

  Change in QoL MLHFQ. The MLHFQ score is used to measure quality of life. The MLHFQ consists of 21 questions answered on a 0-5 likert scale, with higher scores indicating a stronger impact of heart failure on QoL.

  baseline to 12 months

Secondary Outcomes (10)

• All-cause mortality

  Baseline to a minimum of 12 months

• Heart Failure Events

  Baseline to a minimum of 12 months

• Changes in LVEF

  Baseline to 12 months

• Quality of Life Questionnaire

  Baseline to a minimum of 12 months

• Composite of all-cause mortality and heart failure

  Baseline to a minimum of 12 months

Study Arms (2)

Optimal Medical therapy plus ICD

ACTIVE COMPARATOR

Patients randomized to the (ICD) Implantable-Defibrillator-Cardioverter only group will receive an ICD + optimal medical therapy

Device: Optimal Medical therapy plus ICD

Optimal Medical therapy plus CRT/ICD

ACTIVE COMPARATOR

Patients randomized to the (ICD) Implantable-Defibrillator-Cardioverter plus cardiac resynchronisation therapy (CRT) group will receive an ICD + CRT and optimal medical therapy

Device: Optimal Medical therapy plus CRT/ICD

Interventions

Optimal Medical therapy plus ICD DEVICE

Optimal Medical therapy plus ICD

Optimal Medical therapy plus CRT/ICD DEVICE

Optimal Medical therapy plus CRT/ICD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with NYHA Class II or III HF symptoms (assessment in the last 3 months)
• Permanent AF
• Optimal Medical Therapy for HF of at least 3 months (according to 2009 ACCF/AHA and ESC 2012 recommendations,)
• LVEF ≤ 35% (assessment in the last 6 months)
• Candidacy for an ICD for primary or secondary prevention of sudden cardiac death
• QRS durations ≥ 130 ms when the QRS morphology is LBBB, or QRS durations ≥ 150 ms when the QRS morphology is non-LBBB or Paced QRS

You may not qualify if:

• In-hospital patients who have acute cardiac or non-cardiac illness that requires intensive care
• Intra-venous inotropic agent in the last 4 days
• Patients with a life expectancy of less than one year from non-cardiac cause.
• Expected to undergo cardiac transplantation within one year (status I)
• Acute coronary syndrome (including MI) \< 4 weeks
• Unable or unwilling to provide informed consent
• Uncorrected or uncorrectable primary valvular disease
• Restrictive, hypertrophic or reversible form of cardiomyopathy
• Severe primary pulmonary disease such as cor pulmonale
• Tricuspid prosthetic valve
• Patients included in other clinical trial that will affect the objectives of this study
• Coronary revascularization (CABG or PCI) \< 3 months
• Patients with an existing ICD or CRT pacemaker

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (15)

Libin Cardiovascular Institute of Alberta

Calgary, Alberta, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, Canada

Location

Victoria Cardiac Arrhythmia Trials

Victoria, British Columbia, V8R 4R2, Canada

Location

St. Boniface General Hospital

Winnipeg, Manitoba, Canada

Location

Queen Elizabeth II Health Science

Halifax, Nova Scotia, Canada

Location

Hamilton Health Sciences

Hamilton, Ontario, Canada

Location

Kingston General Hospital

Kingston, Ontario, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

University of Ottawa Heart Institute

Ottawa, Ontario, K1W 4W7, Canada

Location

St. Michael's General Hospital

Toronto, Ontario, Canada

Location

CHUM Centre hospitalier universitaire de Montréal

Montreal, Quebec, Canada

Location

McGill Health Science Centre

Montreal, Quebec, Canada

Location

Montreal Heart Institute

Montreal, Quebec, Canada

Location

Institut universitaire de cardiologie et de pneumologie de Quebec

Québec, Quebec, Canada

Location

Le Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Location

Related Publications (1)

• Tang AS, Wells GA, Talajic M, Arnold MO, Sheldon R, Connolly S, Hohnloser SH, Nichol G, Birnie DH, Sapp JL, Yee R, Healey JS, Rouleau JL; Resynchronization-Defibrillation for Ambulatory Heart Failure Trial Investigators. Cardiac-resynchronization therapy for mild-to-moderate heart failure. N Engl J Med. 2010 Dec 16;363(25):2385-95. doi: 10.1056/NEJMoa1009540. Epub 2010 Nov 14.

  PMID: 21073365 BACKGROUND

MeSH Terms

Conditions

Heart Diseases; Heart Failure; Atrial Fibrillation

Interventions

Defibrillators, Implantable

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Defibrillators; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Electrodes, Implanted; Prostheses and Implants

Study Officials

• Anthony SL Tang, MD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2013
• First Posted: November 25, 2013
• Study Start: June 4, 2014
• Primary Completion: January 31, 2024
• Study Completion: May 29, 2025
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

CA (15)