Atrial Fibrillation (AF)REDO-AFNCT07245147
REDO-AF: Randomized Evaluation of Dual Options for AF Re-intervention
A study testing Redo AF Ablation and Pace and Ablate in people with Atrial Fibrillation (AF) and AV Node Ablation, run by Jacqueline Joza at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), AV Node Ablation, Left Bundle Branch Pacing
- What is being tested?
- Redo AF Ablation and Pace and Ablate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2025to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Being tested
- Redo AF Ablation, Pace and Ablate
- Keywords
- Atrial fibrillation, pace and ablate, AV node ablation, Left bundle branch pacing, LBBP, Redo
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Redo AF AblationProcedure or surgery
Redo AF Ablation as per operator discretion
Pace and AblateProcedure or surgery
Left bundle branch pacing with AV node ablation
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | LBBP + AV Node ablation Receives: Procedure: Pace and Ablate |
| Control | Active comparator | Redo AF ablation Receives: Procedure: Redo AF Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Quality of Life Improvements
MLHFQ
Measured: 1 year
Feasibility of Enrolment
Feasibility of Enrolment
Measured: 1 year
Procedural and Device-Related Complications not requiring a hospitalization
Component of the Definitive Trial; collected as a secondary endpoint for the vanguard
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study startNov 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The REDO AF Trial is a prospective, randomized, controlled, open-label multicenter study design (PROBE) with 1:1 randomization.
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jacqueline Joza
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jacqueline Joza, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07245147
- Sponsor's protocol ID
- MP-37-2025-11136
- Acronym
- REDO-AF
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REDO-AF: Randomized Evaluation of Dual Options for AF Re-intervention
- ClinicalTrials.gov ID
- NCT07245147
- Acronym / sponsor ID
- REDO-AF / MP-37-2025-11136
- Keywords
- Atrial fibrillation, pace and ablate, AV node ablation, Left bundle branch pacing, LBBP, Redo
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Jacqueline JozaUniversity, hospital or other
- Study start
- Nov 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The REDO AF Trial is a prospective, randomized, controlled, open-label multicenter study design (PROBE) with 1:1 randomization.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Procedure: Pace and AblateLBBP + AV Node ablation |
| Control | Active comparator | Procedure: Redo AF AblationRedo AF ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Redo AF AblationRedo AF Ablation as per operator discretion | Procedure or surgery | Control |
| Pace and AblateLeft bundle branch pacing with AV node ablation | Procedure or surgery | Experimental |
Primary outcome
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.
Quality of Life Improvements
Time frame: 1 year
MLHFQ
Feasibility of Enrolment
Time frame: 1 year
Feasibility of Enrolment
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Redo AF Ablation and Pace and Ablate in people with Atrial Fibrillation (AF) and AV Node Ablation, run by Jacqueline Joza at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacqueline Joza, MD MSc (514-934-1934, jacqueline.joza@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Hospitalization (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.