RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-03-19
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06056271

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.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patients 21 years of age or older who is:
  2. * indicated for AF ablation or
  3. * Who has received an AF-ablation with the past 24 months where VX1 was used or
  4. 2. Patients are receiving or received a catheter ablation procedure for AF according to current guidelines
  5. 3. Patients must be able and willing to provide written informed consent to participate in the clinical trial
  1. 1. Patients not indicated or were not indicated for catheter ablation according to current guidelines
  2. 2. Patients with AF secondary to an obvious reversible cause
  3. 3. Patients who are or may potentially be pregnant
  4. 4. Enrollment in an investigational study evaluating another non-VX1 investigational device, biologic, or drug

Contacts and Locations

Study Contact

Daniel Guerrero
CONTACT
612-227-1483
daniel.guerrero@volta-medical.com

Study Locations (Sites)

Endeavor Health
Evanston, Illinois, 60201
United States
Kansas City Cardiac Arrhythmia Research LLC
Overland Park, Kansas, 66211
United States
Northwell Health
New York, New York, 10075
United States
Ohio State University
Columbus, Ohio, 43210
United States

Collaborators and Investigators

Sponsor: Volta Medical

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-19
Study Completion Date2027-12

Study Record Updates

Study Start Date2024-03-19
Study Completion Date2027-12

Terms related to this study

Additional Relevant MeSH Terms

  • Atrial Fibrillation