Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-24 @ 11:25 PM
NCT ID:
NCT03355456
Brief Summary:
A two-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. an approach of pulmonary vein isolation (PVI) alone.
Detailed Description:
Patients that meet both inclusion and exclusion criteria will be randomized by the study clinical center upon determination of low-voltage being present using 3-D mapping during index. Enrolled subjects who do not have low voltage will be followed in a registry and their data will be evaluated separately. Low-voltage patients will be randomized 1:1 into one of the following arms:
* PVI with additional total left atrial low voltage-directed ablation.
* PVI alone.
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 recommend the use of implantable loop recorders (ILR) but continuous 30 day monitoring with auto-trigger function may be substituted at the 6, 9 and 12 month time points. The ILR device will be implanted 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. iWatch, Kardia or other non-FDA approved cardiac monitoring can be used to preliminarily identify AF recurrence but AF recurrence must be separately verifiable by ECG or other FDA-certified monitoring system.
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.
Study:
NCT03355456
Study Brief:
Protocol Section:
NCT03355456