RECRUITINGOBSERVATIONAL
Clinical and Healthcare Outcomes From Real-World Use in the United States of a Companion AI During AF Ablation
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
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 willing to sign a consent form to participate in the clinical trial
Who Should NOT Join This Trial:
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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DEVICE
AF Ablation
Percutaneous, catheter-based ablation of atrial fibrillation
Locations (4)
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