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Recruiting NCT06056271

Clinical and Healthcare Outcomes From Real-World Use in the United States of a Companion AI During AF Ablation

— Observational Atrial Fibrillation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AF Ablation.
Who it may be relevant to
Registry conditions: Atrial Fibrillation. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 4 centers
  • Endeavor Health — Evanston
  • Kansas City Cardiac Arrhythmia Research LLC — Overland Park
  • Northwell Health — New York
  • Ohio State University — Columbus

Identifiers

NCT: NCT06056271 · CLIPL-01-005

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗