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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04216667 on ClinicalTrials.gov