ACTIVE_NOT_RECRUITING

STOP Persistent AF PAS

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

The STOP Persistent AF Post Approval Study (PAS) is a prospective, global, multicenter, observational trial.

Official Title

STOP Persistent AF Post-Approval Study, a Sub-study to the Cryo Global Registry

Quick Facts

Study Start:2021-08-19
Study Completion:2028-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05005949

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:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subject has been diagnosed with persistent AF.
  2. * Subject is ≥ 18 years of age or minimum age as required by local regulations.
  3. * Planned pulmonary vein isolation (PVI) procedure using commercially available Arctic Front™ Cardiac Cryoablation Catheter System.
  4. * Willing to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements.
  1. * Subject has had a prior atrial ablation (except for cavo-tricuspid isthmus (CTI) ablation for AFL).
  2. * Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager.
  3. * Subject with exclusion criteria required by local law.

Contacts and Locations

Principal Investigator

Khaldoun Tarakji, MD
STUDY_DIRECTOR
Medtronic CAS Chief Medical Officer

Study Locations (Sites)

Hartford Hospital
Hartford, Connecticut, 06102
United States
Cardiology Associates of Fairfield County
Stamford, Connecticut, 06905-5522
United States
BayCare Medical Group Cardiology
Clearwater, Florida, 33756
United States
Heart Rhythms Solutions
Davie, Florida, 33328
United States
Carle Foundation Hospital
Urbana, Illinois, 61801-2500
United States
Henry Ford Heart & Vascular
Detroit, Michigan, 48202-2608
United States
Spectrum Health Hospitals
Grand Rapids, Michigan, 49525-6427
United States
The Lindner Research Center
Cincinnati, Ohio, 45219-2906
United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705-1852
United States
Texas Health Research & Education Institute
Dallas, Texas, 75231
United States

Collaborators and Investigators

Sponsor: Medtronic Cardiac Ablation Solutions

  • Khaldoun Tarakji, MD, STUDY_DIRECTOR, Medtronic CAS Chief Medical Officer

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 Date2021-08-19
Study Completion Date2028-07

Study Record Updates

Study Start Date2021-08-19
Study Completion Date2028-07

Terms related to this study

Additional Relevant MeSH Terms

  • Persistent Atrial Fibrillation