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

Atrial Fibrillation Clinical Trial

— COMPANION AI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06056271
• Other study ID #: CLIPL-01-005
• Status: Recruiting
• Start date: March 19, 2024
• Est. completion date: December 2027

Study information

• Verified date: April 2024
• Source: Volta Medical
• Contact: Daniel Guerrero
• Phone: 612-227-1483
• Email: daniel.guerrero[@]volta-medical.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• AF Ablation
Percutaneous, catheter-based ablation of atrial fibrillation

Locations

Country	Name	City	State
United States	Ohio State University	Columbus	Ohio
United States	Northwell Health	New York	New York
United States	Kansas City Cardiac Arrhythmia Research LLC	Overland Park	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Volta Medical	Heart Rhythm Clinical and Research Solutions, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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