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

Sponsor

Volta Medical (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06056271

Collaborator

Heart Rhythm Clinical and Research Solutions, LLC (Other)

400

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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-Explorer systems during AF ablation procedures.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Device: AF Ablation

Study Design

Study Type:

Observational

Anticipated Enrollment :

400 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2027

Anticipated Study Completion Date :

Dec 1, 2027

Outcome Measures

Primary Outcome Measures

Primary Clinical Efficacy Outcome [12 and 24 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Volta Medical
Heart Rhythm Clinical and Research Solutions, LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Volta Medical

ClinicalTrials.gov Identifier:

NCT06056271

Other Study ID Numbers:

CLIPL-01-005

First Posted:

Sep 28, 2023

Last Update Posted:

Sep 28, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Atrial Fibrillation

Study Results

No Results Posted as of Sep 28, 2023