NCT06056271 · Volta Medical
Clinical and Healthcare Outcomes From Real-World Use in the United States of a Companion AI During AF Ablation
(COMPANION AI)
What this study 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.
View original scientific description
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
DEVICE
AF Ablation
Percutaneous, catheter-based ablation of atrial fibrillation
Primary outcome measures
Primary Clinical Efficacy Outcome
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Evanston, Illinois
- Overland Park, Kansas
- New York, New York
- Columbus, Ohio
Collaborators
Heart Rhythm Clinical and Research Solutions, LLC
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 10, 2025 · Source of record for eligibility and locations