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
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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RECRUITING
400 participants
OBSERVATIONAL
2024-03-19
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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AF Ablation
Percutaneous, catheter-based ablation of atrial fibrillation
Eligibility Criteria
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Inclusion Criteria
* 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
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
21 Years
ALL
No
Sponsors
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Heart Rhythm Clinical and Research Solutions, LLC
OTHER
Volta Medical
INDUSTRY
Responsible Party
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Locations
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Endeavor Health
Evanston, Illinois, United States
Kansas City Cardiac Arrhythmia Research LLC
Overland Park, Kansas, United States
Northwell Health
New York, New York, United States
Ohio State University
Columbus, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CLIPL-01-005
Identifier Type: -
Identifier Source: org_study_id
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