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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Atrial Fibrillation (AF); Left Bundle Branch Pacing; AV Node Ablation
• Intervention / Treatment: Procedure: Pace and Ablate; Procedure: Redo AF Ablation

Detailed Description

Recurrence rates after atrial fibrillation (AF) ablation procedures are high at approximately 50% at 18 months and are associated with procedural risk as well as with significant costs. There is limited guidance on how best to treat those who recur post AF ablation. The combination of pacemaker implantation and atrioventricular node ablation (AVNA), so-called "pace-and-ablate" strategy, is an alternative treatment in patients who are at high risk of AF recurrence, especially since the recent introduction of left bundle branch pacing (LBBP). LBBP is a type of pacing strategy that captures the intrinsic conduction system and preserves normal physiological ventricular activation. The REDO-AF Trial will compare a strategy of pace-and-ablate therapy with LBBP + AVNA as compared to a strategy of redo AF ablation in medically refractory patients presenting with recurrent symptomatic AF post AF ablation. We hypothesize that a pace-and-ablate strategy will result in reduction in cardiovascular hospitalizations, procedural complications and an improvement in quality of life (QOL). The definitive research question of the REDO-AF trial is: Can a strategy of LBBP combined with AVNA in patients with recurrent, symptomatic, drug-refractory AF after previous AF ablation(s), who remain at high risk of recurrence, lead to a reduction in cardiovascular hospitalizations, reduction in procedure or device-related complications, and a greater improvement in QOL as compared to a subsequent (redo) AF ablation.

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jacqueline Joza, MD MSc; Phone Number: 514-934-1934; Email: jacqueline.joza@gmail.com

Study Locations

• Canada
  • Montreal, Canada
    • McGill University Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; LBBP + AV Node ablation	Procedure: Pace and Ablate; Left bundle branch pacing with AV node ablation
Active Comparator: Control; Redo AF ablation	Procedure: Redo AF Ablation; Redo AF Ablation as per operator discretion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Jacqueline Joza

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 20, 2025
• First Posted (Actual): November 24, 2025

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Atrial fibrillation; AV node ablation; LBBP; Left bundle branch pacing; pace and ablate; Redo
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation; Hydrolases; Enzymes; Enzymes and Coenzymes; Endopeptidases; Peptide Hydrolases; Serine Endopeptidases; Serine Proteases; Proprotein Convertases; Furin
• Other Study ID Numbers: MP-37-2025-11136

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No