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

ConditionsAtrial Fibrillation (AF)AV Node AblationLeft Bundle Branch Pacing
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Redo AF Ablation

    Procedure/Surgery

    Redo AF Ablation as per operator discretion

  • Pace and Ablate

    Procedure/Surgery

    Left bundle branch pacing with AV node ablation

Treatment groups

16 Participants
are divided into 2 treatment groups
Group A: ExperimentalExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1 year
2

Quality of Life Improvements

MLHFQ

Time frame
1 year
3

Feasibility of Enrolment

Feasibility of Enrolment

Time frame
1 year
4

Procedural and Device-Related Complications not requiring a hospitalization

Component of the Definitive Trial; collected as a secondary endpoint for the vanguard

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jacqueline Joza

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: