NCT01994252Completed
Resynchronization/Defibrillation for Ambulatory Heart Failure Trial in Patients With Permanent Atrial Fibrillation
Source: ClinicalTrials.gov · Last updated 30 Apr 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 8 Nov 2013
- Start date
- 4 Jun 2014
- Primary completion date
- 31 Jan 2024
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Diseases
- Heart failure, Atrial fibrillation
- NCT number
- NCT01994252
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 4 Jun 2014 to the primary completion date, 31 Jan 2024
- 15 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- In-hospital patients who have acute cardiac or non-cardiac illness that requires intensive care
- 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
- Uncorrected or uncorrectable primary valvular disease
- Severe primary pulmonary disease such as cor pulmonale
Other
- Intra-venous inotropic agent in the last 4 days
- Unable or unwilling to provide informed consent
- Restrictive, hypertrophic or reversible form of cardiomyopathy
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Libin Cardiovascular Institute of Alberta Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Queen Elizabeth II Health Science Coordinator of this site? Confirm its status | Halifax | Canada | Unknown status |
| Hamilton Health Sciences Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| Kingston General Hospital Coordinator of this site? Confirm its status | Kingston | Canada | Unknown status |
| London Health Sciences Centre Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| McGill Health Science Centre Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Montreal Heart Institute Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| CHUM - Centre hospitalier universitaire de Montreal Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| University of Ottawa Heart Institute Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| Institut universitaire de cardiologie et de pneumologie de Québec Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| Le Centre hospitalier universitaire de Sherbrooke Coordinator of this site? Confirm its status | Sherbrooke | Canada | Unknown status |
| St. Michael's General Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Vancouver General Hospital Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| Victoria Cardiac Arrhythmia Trials Coordinator of this site? Confirm its status | Victoria | Canada | Unknown status |
| St. Boniface General Hospital Coordinator of this site? Confirm its status | Winnipeg | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.