REDO-AF: Randomized Evaluation of Dual Options for AF Re-intervention
Key facts
- Where
- Montreal, KanadaSee the site
Where in Kanada
- McGill University Health CenterMontreal, KanadaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Jacqueline Joza
- Trial code
- NCT07245147
- Record updated
- 2025. november 24.
- Original description
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 full original descriptionShow less
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.
Inclusion: 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: Myocardial infarction, stroke, or coronary revascularization within the previous 3 months; Severe valvular disease defined by echo criteria; LVEF <40% or need for an ICD; Life expectancy <24 months; Lack of capacity to consent.