Redo AF Ablation: Redo AF Ablation as per operator discretion
Pace and Ablate: Left bundle branch pacing with AV node ablation
Study 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 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Cardiac Hospitalization — 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 — 1 year MLHFQ
Feasibility of Enrolment — 1 year Feasibility of Enrolment
Procedural and Device-Related Complications not requiring a hospitalization — 1 year Component of the Definitive Trial; collected as a secondary endpoint for the vanguard
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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