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

November 20, 2025 updated by: Jacqueline Joza
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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
      • Montreal, Canada
        • McGill University Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cardiac Hospitalization
Time Frame: 1 year
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
Time Frame: 1 year
MLHFQ
1 year
Feasibility of Enrolment
Time Frame: 1 year
Feasibility of Enrolment
1 year
Procedural and Device-Related Complications not requiring a hospitalization
Time Frame: 1 year
Component of the Definitive Trial; collected as a secondary endpoint for the vanguard
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jacqueline Joza

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 24, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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