Clinical and Healthcare Outcomes From Real-World Use in the United States of a Companion AI During AF Ablation
COMPANION AI
1 other identifier
observational
400
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2024
Typical duration for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2023
CompletedFirst Posted
Study publicly available on registry
September 28, 2023
CompletedStudy Start
First participant enrolled
March 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
December 10, 2025
December 1, 2025
3.7 years
September 20, 2023
December 2, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Primary Clinical Efficacy Outcome
Percentage of subjects free from clinically significant AF or atrial arrhythmia recurrences, after one or multiple ablation procedures, stratified by type of clinical workflow and ablation history.
12 and 24 months
Interventions
Percutaneous, catheter-based ablation of atrial fibrillation
Eligibility Criteria
Adult patients indicated for ablation for atrial fibrillation
You may qualify if:
- 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
You may not qualify if:
- 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
- Enrollment in an investigational study evaluating another non-VX1 investigational device, biologic, or drug
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Volta Medicallead
- Heart Rhythm Clinical and Research Solutions, LLCcollaborator
Study Sites (4)
Endeavor Health
Evanston, Illinois, 60201, United States
Kansas City Cardiac Arrhythmia Research LLC
Overland Park, Kansas, 66211, United States
Northwell Health
New York, New York, 10075, United States
Ohio State University
Columbus, Ohio, 43210, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2023
First Posted
September 28, 2023
Study Start
March 19, 2024
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
December 10, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share