NCT06056271 Clinical and Healthcare Outcomes From Real-World Use in the United States of a Companion AI During AF Ablation
| NCT ID | NCT06056271 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Volta Medical |
| Condition | Atrial Fibrillation |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2024-03-19 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2024-03-19 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06056271 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06056271 currently recruiting?
Yes, NCT06056271 is actively recruiting participants. Contact the research team at daniel.guerrero@volta-medical.com for enrollment information.
Where is the NCT06056271 trial being conducted?
This trial is being conducted at Evanston, United States, Overland Park, United States, New York, United States, Columbus, United States.
Who is sponsoring the NCT06056271 clinical trial?
NCT06056271 is sponsored by Volta Medical. The trial plans to enroll 400 participants.
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