Prospective, Multi-center, Randomized, Evaluation Comparing the Protocol Specified Ablation Approach to the Current Standardized Ablation Approach in the Treatment of Non-paroxysmal Atrial Fibrillation.
Ohad Ziv
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.
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 ta…
Eligibility
- Age range
- 18–85 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Subjects must meet all of the following criteria: 1. Non-Paroxysmal Atrial Fibrillation. 2. Failed or intolerable to at least 1 one antiarrhythmic drug (AAD). 3. 18-85 year of age at time of consent. 4. Scheduled to undergo a clinically indicated AF ablation procedure. 5. Able and willing to comply with all protocol visit requirements. 6. Signed Patient Informed Consent (ICF). 7. Presence of low voltage in the left atrium on 3-D map during index catheter ablation procedure Exclusion Criteria: Subjects will be excluded if any of the follow criteria are present: 1. Histo…
Interventions
- ProcedureRadiofrequency ablation
Ablation procedure to eliminate atrial fibrillation
Location
- MetroHealth Medical CenterCleveland, Ohio