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NCT06056271Recruiting

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

Source: ClinicalTrials.gov · Last updated 10 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
400 (estimated)
First submitted
20 Sept 2023
Start date
19 Mar 2024
Primary completion date
Dec 2027
Lead sponsor
Volta Medical
NCT number
NCT06056271

What you commit to

  • Study type: Observational
  • Planned participants: 400
  • From 19 Mar 2024 to the primary completion date, Dec 2027
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Enrollment in an investigational study evaluating another non-VX1 investigational device, biologic, or drug

Other

  • Patients not indicated or were not indicated for catheter ablation according to current guidelines
  • Patients with AF secondary to an obvious reversible cause
  • Patients who are or may potentially be pregnant

Who the study is looking for

  • 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
  • Patients are receiving or received a catheter ablation procedure for AF according to current guidelines
  • Patients must be able and willing to provide written informed consent to participate in the clinical trial

Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ohio State University
Coordinator of this site? Confirm its status
ColumbusUnited StatesRecruiting
Endeavor Health
Coordinator of this site? Confirm its status
EvanstonUnited StatesRecruiting
Northwell Health
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
Kansas City Cardiac Arrhythmia Research LLC
Coordinator of this site? Confirm its status
Overland ParkUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.