Atrial Fibrillation
Conditions
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-Xplorer systems during AF ablation procedures.
Interventions
DEVICEAF Ablation
Percutaneous, catheter-based ablation of atrial fibrillation
Sponsors
Heart Rhythm Clinical and Research Solutions, LLC
Volta Medical
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactDaniel Guerrero
Outcome results
None listed