Last updated on September 2018

Low Voltage-Directed Catheter Ablation for Atrial Fibrillation

Brief description of study

A three-pronged approach to evaluate long term success of non-paroxysmal ablation when using a:

  1. specified low voltage-directed with pulmonary vein isolation (LD+PVI) approach compared to ,
  2. empiric posterior wall isolation with pulmonary vein isolation (PW+PVI) approach compared to
  3. an approach of pulmonary vein isolation (PVI) alone.

Detailed Study Description

Patients that meet both inclusion and exclusion criteria will be randomized by the study clinical center. Patients will be randomized 1:1:1 into one of the following arms:

  • PVI with additional total left atrial low voltage-directed ablation.
  • PVI with posterior wall low voltage quantification and isolation
  • PVI alone without low voltage quantification.

All patients will receive the best conventional medical therapy and anticoagulation use based upon HRS consensus recommendations taking into account their baseline risk factors for stroke. The need for interruption of anticoagulation and antiarrhythmic drug therapy for the procedure will be determined by the operator and their center guidelines.

The trial requires continuous monitoring for atrial arrhythmias. Investigators will mandate the use of implantable loop recorders (ILR). The device will be under sterile conditions at the manufacture's recommended site on the precordium for arrhythmia monitoring. Implantation will occur between 1 month prior and 3 months post ablation since there will be a 3 month post ablation blanking period. If a dual chamber device is already present, implantation will not be required.

One year follow-up is planned. Post procedure care is per standard of care with follow-up at 1 month, 3 months, 6 months, 9 months and 12 months. ECG at every follow-up is performed. Download of arrhythmia data will occur at each of these visits as well. Investigators will use the typical post ablation blanking period for recurrence of atrial fibrillation of 3 months. Antiarrhythmic medications can be used during the typical "blanking period" of 3 months post procedure. But per protocol are stopped at 3 months post procedure (2 months post procedure in case of amiodarone).

Investigators will compare time freedom from first arrhythmia event, defined as a sustained episode of atrial fibrillation or atrial tachycardia. Secondary endpoints will be compared as well (see secondary end point defined). Re-initiation of an antiarrhythmic drug after 3 months will be considered a failure of primary endpoint of arrhythmia free survival. However, Anti-arrhythmic medication use after the blanking period for ventricular arrhythmias will not be included as an event. Anticoagulation is continued and monitored based on previous guidelines with use stratified by baseline stroke risk. A recording (CD) of the mapping during the procedure is to be obtained and retained for possible future analysis.

Clinical Study Identifier: NCT03355456

Contact Investigators or Research Sites near you

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Peter Leo BS, RN

MetroHealth Medical Center
Cleveland, OH United States
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