REDO-AF: Randomized Evaluation of Dual Options for AF Re-intervention

NCT07245147 | Not Yet Recruiting DMC

• 1 other identifier: MP-37-2025-11136
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized open-label clinical trial is to evaluate two different strategies for the treatment of recurrent atrial fibrillation (AF) after AF ablation. Patients who have symptomatic, drug-refractory recurrence of AF will be randomized to either a redo AF ablation vs conduction system pacing with AV node ablation. Patients will need to have undergone at least 1 prior AF ablation to be considered eligible for the study. The current trial is a vanguard study of 16 patients and will determine the feasibility of enrolment, compare changes in quality of life, and inform the design of the definitive REDO AF trial.

Conditions

Atrial Fibrillation (AF); AV Node Ablation; Left Bundle Branch Pacing

Keywords

Atrial fibrillation; pace and ablate; AV node ablation; Left bundle branch pacing; LBBP; Redo

Outcome Measures

Primary Outcomes (4)

• Cardiac Hospitalization

  cardiovascular hospitalization defined as a greater or equal to 24 hour stay in hospital due to heart failure, myocardial infarction, stroke/transient ischemic attack or systemic embolism, arrhythmia recurrence, or complications related to the procedure or device implant that require hospitalization), or a hospital visit (of any duration) for re-intervention.

  1 year

• Quality of Life Improvements

  MLHFQ

  1 year

• Feasibility of Enrolment

  Feasibility of Enrolment

  1 year

• Procedural and Device-Related Complications not requiring a hospitalization

  Component of the Definitive Trial; collected as a secondary endpoint for the vanguard

  1 year

Study Arms (2)

Experimental

EXPERIMENTAL

LBBP + AV Node ablation

Procedure: Pace and Ablate

Control

ACTIVE COMPARATOR

Redo AF ablation

Procedure: Redo AF Ablation

Interventions

Redo AF Ablation PROCEDURE

Redo AF Ablation as per operator discretion

Control

Pace and Ablate PROCEDURE

Left bundle branch pacing with AV node ablation

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• One or more prior left atrial (LA) ablation procedure(s) for AF
• Symptomatic AF/atypical atrial flutter/atrial tachycardia with failure of or intolerance to medical rate or rhythm control therapy, that is detected at \>2 months post most recent LA ablation procedure
• Either a LA volume index on any prior echo of \>= 45ml/m2 or LA diameter \>= 50mm OR a HATCH score \>=2 (where 1 point is given for each for hypertension, Age\>75, COPD, and 2 points for each of stroke/TIA, or HF (defined as signs or symptoms of pulmonary edema and may include HFrEF or HFpEF)
• Be considered suitable for both treatment strategies of redo ablation and pacemaker and AV node ablation
• Willingness to participate, complete the QOL questionnaires and ability to sign informed consent

You may not qualify if:

• Severe valvular disease defined by echo criteria
• Myocardial infarction, stroke, or coronary revascularization within the previous 3 months
• LVEF \<40% or need for an ICD
• Life expectancy \<24 months
• Lack of capacity to consent

Sponsors & Collaborators

• Jacqueline Joza: lead

Study Sites (1)

McGill University Health Center

Montreal, Canada

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Furin

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Proprotein Convertases; Serine Proteases

Central Study Contacts

Jacqueline Joza, MD MSc

CONTACT

514-934-1934; jacqueline.joza@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Cardiac Electrophysiologist

Model Details: The REDO AF Trial is a prospective, randomized, controlled, open-label multicenter study design (PROBE) with 1:1 randomization.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)