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

NCT ID: NCT06056271

Last Updated: 2025-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-19

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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AF Ablation

Percutaneous, catheter-based ablation of atrial fibrillation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heart Rhythm Clinical and Research Solutions, LLC

OTHER

Sponsor Role collaborator

Volta Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Endeavor Health

Evanston, Illinois, United States

Site Status RECRUITING

Kansas City Cardiac Arrhythmia Research LLC

Overland Park, Kansas, United States

Site Status RECRUITING

Northwell Health

New York, New York, United States

Site Status RECRUITING

Ohio State University

Columbus, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Daniel Guerrero

Role: CONTACT

612-227-1483

Facility Contacts

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Research Coordinator

Role: primary

Donita Atkins

Role: primary

Other Identifiers

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CLIPL-01-005

Identifier Type: -

Identifier Source: org_study_id

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