REDO-AF: Randomized Evaluation of Dual Options for AF Re-intervention
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJacqueline Joza
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Redo AF Ablation
- Pace and Ablate
Treatment groups
16 Participants
are divided into 2 treatment groupsSponsors and collaborators
Jacqueline Joza
Lead sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor institution
Source ClinicalTrials.gov