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

RecruitingObservational study

Who can join

Ages 21 and older · All sexes

Full eligibility 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

About the study

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.

What is being tested

Sponsor: Volta Medical · Participants: 400 · Started: Mar 19, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06056271

Locations in the U.S.

IllinoisEndeavor Health, Evanston
KansasKansas City Cardiac Arrhythmia Research LLC, Overland Park
New YorkNorthwell Health, New York
OhioOhio State University, Columbus

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.