Clinical and Healthcare Outcomes From Real-World Use in the United States of a Companion AI During AF Ablation
Recruiting · NCT06056271 · Observational (researchers observe without assigning treatment) · Lead sponsor: Volta Medical
View the official record on ClinicalTrials.gov →Interventions studied
AF Ablation
What this trial is about
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 can take part
Age range
21 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
4 locations listed across 4 US states.
- 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