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NCT06056271 | RECRUITING | Atrial Fibrillation

Clinical and Healthcare Outcomes From Real-World Use in the United States of a Companion AI During AF Ablation
Sponsor:

Volta Medical

Brief Summary:

Observational, multi-center, clinical device registry for US patients with a primary goal to observe the clinical outcomes in patients who are mapped with Volta Medical's VX1 or AF-Xplorer systems during AF ablation procedures.

Condition or disease

Atrial Fibrillation

Intervention/treatment

AF Ablation

Study Type : OBSERVATIONAL
Estimated Enrollment : 400 participants
Official Title : Clinical and Healthcare Outcomes From Real-World Use in the United States of a Companion AI During AF Ablation
Actual Study Start Date : 2024-03-19
Estimated Primary Completion Date : 2027-12
Estimated Study Completion Date : 2027-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 21 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Patients 21 years of age or older who is
    • * indicated for AF ablation or
    • * Who has received an AF-ablation with the past 24 months where VX1 was used or
    • 2. Patients are receiving or received a catheter ablation procedure for AF according to current guidelines
    • 3. Patients must be able and willing to provide written informed consent to participate in the clinical trial
    Exclusion Criteria
    • 1. Patients not indicated or were not indicated for catheter ablation according to current guidelines
    • 2. Patients with AF secondary to an obvious reversible cause
    • 3. Patients who are or may potentially be pregnant
    • 4. Enrollment in an investigational study evaluating another non-VX1 investigational device, biologic, or drug
Clinical and Healthcare Outcomes From Real-World Use in the United States of a Companion AI During AF Ablation

Location Details

NCT06056271

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Illinois

Endeavor Health

Evanston, Illinois, United States, 60201

RECRUITING

United States, Kansas

Kansas City Cardiac Arrhythmia Research LLC

Overland Park, Kansas, United States, 66211

RECRUITING

United States, New York

Northwell Health

New York, New York, United States, 10075

RECRUITING

United States, Ohio

Ohio State University

Columbus, Ohio, United States, 43210