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

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-Explorer systems during AF ablation procedures.

Conditions

Atrial Fibrillation

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Study Overview

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Study Details

Study 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-Explorer systems during AF ablation procedures.

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

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

Condition
Atrial Fibrillation
Intervention / Treatment

-

Contacts and Locations

Overland Park

Kansas City Cardiac Arrhythmia Research LLC, Overland Park, Kansas, United States, 66211

New York

Northwell Health, New York, New York, United States, 10075

Columbus

Ohio State University, Columbus, Ohio, United States, 43210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

21 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Volta Medical,

Study Record Dates

2027-12