Posterior Wall And Left Atrial Appendage Empiric Electrical Isolation for Non-Paroxysmal Atrial Fibrillation
NCT04216667 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 124
Last updated 2023-08-31
Summary
The purpose of this study is to evaluate the safety and effectiveness of empirical posterior wall isolation (PWI), left atrial appendage electrical isolation (LAAEI) and coronary sinus isolation (CSI) when compared to pulmonary vein isolation (PVI) alone:
* PVI alone,
* PVI + PWI,
* PVI + PWI + LAAEI,
* PVI + PWI + LAAEI + CSI.
Conditions
Interventions
- PROCEDURE
-
Catheter ablation
Catheter ablation
Sponsors & Collaborators
-
Biosense Webster, Inc.
collaborator INDUSTRY -
Montefiore Medical Center
lead OTHER
Principal Investigators
-
Jorge E Romero, MD · Montefiore Medical Center/Albert Einstein College of Medicine
-
Luigi Di Biase, MD, PhD · Montefiore Medical Center/Albert Einstein College of Medicine
-
Andrea Natale, MD · Texas Cardiac Arrhythmia Institute and St. David's Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-01-16
- Primary Completion
- 2023-06-30
- Completion
- 2023-06-30
Countries
- United States
- Argentina
- Brazil
- Colombia
- Germany
- Portugal
- Turkey (Türkiye)
Study Locations
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