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

Part of paid clinical trials in Evanston, Illinois.

Sponsor
Volta Medical
Study ID
NCT06056271
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AF Ablation — DEVICE
    Percutaneous, catheter-based ablation of atrial fibrillation

Study Details

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.

Key Dates

Start date
Mar 19, 2024
Status verified
Dec 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
400 participants (estimated)

Primary Outcome Measure

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

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Endeavor HealthEvanstonIllinois60201
Research Coordinator
Kansas City Cardiac Arrhythmia Research LLCOverland ParkKansas66211
Donita Atkins
Dhanunjaya Lakkireddy, MD (PRINCIPAL_INVESTIGATOR)
Northwell HealthNew YorkNew York10075-
Ohio State UniversityColumbusOhio43210-

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