Recruiting

Volta Medical's VX1, AF-Explorer

Sponsor:

Volta Medical

Code:

NCT06056271

Conditions

Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

AF Ablation

Study Details

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.

Conditions

Atrial Fibrillation

Study ID

NCT06056271

Start date

Mar 19, 2024

Status verified date

Dec, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Interventions

AF Ablation

Percutaneous, catheter-based ablation of atrial fibrillation

Primary outcome measure

  • Primary Clinical Efficacy Outcome [ Time Frame: 12 and 24 months ]

Central Contacts and Locations

Central contacts

Locations

Endeavor Health

Recruiting

Evanston, Illinois, United States, 60201

Contacts

Research Coordinator

mdurante@northshore.org

Kansas City Cardiac Arrhythmia Research LLC

Recruiting

Overland Park, Kansas, United States, 66211

Contacts

Principal Investigator:

Dhanunjaya Lakkireddy, MD

Northwell Health

Recruiting

New York, New York, United States, 10075

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

More Information

Sponsor

Volta Medical

Last update posted

Dec 10, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Volta Medical on 2025-12-10.