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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

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 more

Secondary study objectives

6 Minute walk distance

Perinatal death

Cardiovascular hospitalizations

+6 more

Awards & 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

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