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

Recruiting

• Conditions: Atrial Fibrillation

• Registration Number: NCT06056271
• Lead Sponsor: Volta Medical

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-20
• Study First Submitted QC: 2023-09-20
• Study First Posted: 2023-09-28
• Study Start: 2024-03-19
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-24
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (3)

Ohio State University; 🇺🇸 Columbus, Ohio, United States

Kansas City Cardiac Arrhythmia Research LLC; 🇺🇸 Overland Park, Kansas, United States

Northwell Health; 🇺🇸 New York, New York, United States