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Device
CRT/ICD + Optimal Medical Therapy for Heart Failure with Atrial Fibrillation (RAFT-PermAF Trial)
N/A
Waitlist Available
Led By Anthony SL Tang, MD
Research Sponsored by Ottawa Heart Institute Research Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether adding pacing to both ventricles is of benefit in heart failure patients with a permanent irregular heart rhythm (atrial fibrillation).
Who is the study for?
This trial is for heart failure patients with permanent atrial fibrillation, NYHA Class II or III symptoms, and a left ventricular ejection fraction (LVEF) ≤ 35%. They must have been on optimal medical therapy for at least 3 months and be candidates for an implantable defibrillator. Exclusions include acute illness requiring intensive care, certain heart conditions like severe valve disease, recent coronary procedures, or those expected to undergo cardiac transplantation within a year.
What is being tested?
The study tests if adding biventricular pacing (pacing both ventricles) to standard treatment with an implantable cardioverter-defibrillator (ICD) can reduce heart size and improve function in patients who have both heart failure and permanent atrial fibrillation. It compares this approach against the usual ICD treatment without additional pacing.
What are the potential side effects?
Potential side effects may include complications from device implantation such as infection or bleeding, inappropriate shocks from the ICD if it mistakenly detects an abnormal rhythm, discomfort from the device itself, and possible worsening of heart failure symptoms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The is a hierarchy (winratio) of 1) all-cause mortality
The 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
The is a hierarchy (winratio) of 3) Left ventricular ejection fraction
+1 moreSecondary study objectives
6 Minute walk distance
Perinatal death
Cardiovascular hospitalizations
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Optimal Medical therapy plus CRT/ICDActive Control1 Intervention
Patients randomized to the (ICD) Implantable-Defibrillator-Cardioverter plus cardiac resynchronisation therapy (CRT) group will receive an ICD + CRT and optimal medical therapy
Group II: Optimal Medical therapy plus ICDActive Control1 Intervention
Patients randomized to the (ICD) Implantable-Defibrillator-Cardioverter only group will receive an ICD + optimal medical therapy
Find a Location
Who is running the clinical trial?
Ottawa Heart Institute Research CorporationLead Sponsor
196 Previous Clinical Trials
93,497 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,394 Previous Clinical Trials
26,527,658 Total Patients Enrolled
Anthony SL Tang, MDPrincipal InvestigatorOttawa Heart Institute Research Corporation