← Back to Search

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

RAFT-PermAF Trial 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.Check my eligibility

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.See study design

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.

RAFT-PermAF Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

6 Minute walk distance

Perinatal death

Cardiovascular hospitalizations

+6 more

RAFT-PermAF 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Ottawa Heart Institute Research CorporationLead Sponsor

188 Previous Clinical Trials

92,236 Total Patients Enrolled

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,341 Previous Clinical Trials

26,452,513 Total Patients Enrolled

Anthony SL Tang, MDPrincipal InvestigatorOttawa Heart Institute Research Corporation

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can you provide a breakdown of the sites hosting this research in North America?

"This clinical trial is conducted at Institut universitaire de cardiologie et de pneumologie de Quebec in Quebec City, Le Centre hospitalier universitaire de Sherbrooke in Sherbrooke, and Victoria Cardiac Arrhythmia Trials in Victoria. An additional 16 sites are mentioned as well."

Answered by AI

What is the participant capacity for this clinical investigation?

"Affirmative. According to the details provided on clinicaltrials.gov, this investigation is still recruiting participants and has been since August 1st 2013 - its last revision was dated March 23rd 2022. It's looking for 200 people across 16 various medical facilities."

Answered by AI

Does this research project require any more participants at present?

"Affirmative. According to the clinicaltrials.gov website, this study is actively enrolling volunteers; it was initially posted in August 2013 and most recently updated on March 23rd 2022. Two hundred participants are needed from 16 different locations for this trial."

Answered by AI

Recent research and studies

New England Journal of MedicineJournal

Cardiac-resynchronization Therapy for Mild-to-moderate Heart Failure

Tang, Anthony S.L., George A. Wells, Mario Talajic, Malcolm O. Arnold, Robert Sheldon, Stuart Connolly, Stefan H. Hohnloser, et al.. 2010. “Cardiac-resynchronization Therapy for Mild-to-moderate Heart Failure”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1009540.

clinicaltrials.govStudy

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

2013. "Resynchronization/Defibrillation for Ambulatory Heart Failure Trial in Patients With Permanent Atrial Fibrillation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01994252.

All > Heart Failure With Preserved Ejection Fraction