NCT05118893

Brief Summary

This is an extended follow up study of the original RAFT-AF Study. The RAFT-AF study was a multi-centre randomized controlled trial with a prospective randomized open blinded endpoint trial (PROBE) design. Patients were randomized to either catheter ablation-based rhythm control of AF as compared to rate control of AF

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
324

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2023

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 12, 2021

Completed
1.5 years until next milestone

Study Start

First participant enrolled

May 8, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

March 24, 2025

Status Verified

March 1, 2025

Enrollment Period

1.3 years

First QC Date

October 6, 2021

Last Update Submit

March 20, 2025

Conditions

Keywords

atrial fibrillationheart failurelong-term follow up

Outcome Measures

Primary Outcomes (1)

  • Composite of mortality and Heart Failure Events

    Death or HF Event ( admit \> 24 hrs or urgent out patient or ER visit for IV diuretics)

    24 months

Secondary Outcomes (2)

  • all-cause mortality

    24 months

  • Heart Failure Events

    24 months

Study Arms (2)

Ablation-based rhythm-control

Ablation-based rhythm-control consisted of pulmonary vein isolation in paroxysmal atrial fibrillation, and additional ablation for persistent atrial fibrillation

Rate-control

Rate-control included AV-nodal blocking agents and AV node ablation with permanent pacing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All eligible patients enrolled in the original RAFT-AF Study

You may qualify if:

  • All patients previously enrolled and randomized in the RAFT-AF Study that are eligible to enroll

You may not qualify if:

  • Did not participate in the original RAFT-AF Study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Libin Cardiovascular Institute

Calgary, Alberta, Canada

Location

Victoria Cardiac Arrhythmia Trials

Victoria, British Columbia, Canada

Location

Queen Elizabeth II Health Science

Halifax, Nova Scotia, Canada

Location

Hamilton Health Sciences Centre

Hamilton, Ontario, Canada

Location

Kingston General Hospital

Kingston, Ontario, Canada

Location

St. Mary's General Hospital

Kitchener, Ontario, Canada

Location

London Health Science Centre

London, Ontario, Canada

Location

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Location

McGill University Health Centre

Montreal, Quebec, Canada

Location

Montreal Heart Institute

Montreal, Quebec, Canada

Location

CHUS Le Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Location

MeSH Terms

Conditions

Atrial FibrillationHeart Failure

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Anthony Tang

    London Health Sciences Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Medicine, Western University

Study Record Dates

First Submitted

October 6, 2021

First Posted

November 12, 2021

Study Start

May 8, 2023

Primary Completion

August 30, 2024

Study Completion

August 30, 2024

Last Updated

March 24, 2025

Record last verified: 2025-03

Locations