RECRUITING

STOP AF First Post-Approval Study

Conditions

Quick Navigation

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 AF First PAS is a prospective, global, multi-center, observational trial.

Official Title

STOP AF First Post-Approval Study, an Addendum to the Cryo Global Registry

Quick Facts

Study Start:2022-04-28

Study Completion:2028-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05227053

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 Criteria	Exclusion Criteria
* Subject has been diagnosed with symptomatic paroxysmal AF * Subject is ≥ 18 years of age or minimum age as required by local regulations * Planned pulmonary vein isolation (PVI) procedure using the commercially available Arctic Front™ cardiac cryoablation catheter System at least 7 calendar days post study enrollment to allow for pre-ablation baseline data collection from sensor device * 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	* History of AF treatment with class I or III antiarrhythmic drug (AAD), including sotalol, with the intention to prevent an AF recurrence. However, patients pretreated with above AAD for less than 7 days prior to planned PVI procedure or with the intention to convert an AF episode are allowed. * Subject has had a prior atrial ablation (except for cavo-tricuspid isthmus (CTI) ablation for AFL) * Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager * Subject with exclusion criteria required by local law

Inclusion Criteria

Exclusion Criteria

* Subject has been diagnosed with symptomatic paroxysmal AF
* Subject is ≥ 18 years of age or minimum age as required by local regulations
* Planned pulmonary vein isolation (PVI) procedure using the commercially available Arctic Front™ cardiac cryoablation catheter System at least 7 calendar days post study enrollment to allow for pre-ablation baseline data collection from sensor device
* 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

* History of AF treatment with class I or III antiarrhythmic drug (AAD), including sotalol, with the intention to prevent an AF recurrence. However, patients pretreated with above AAD for less than 7 days prior to planned PVI procedure or with the intention to convert an AF episode are allowed.
* Subject has had a prior atrial ablation (except for cavo-tricuspid isthmus (CTI) ablation for AFL)
* Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager
* Subject with exclusion criteria required by local law

Contacts and Locations

Study Contact

Ryan Radtke

CONTACT

712.941.9372

ryan.s.radtke@medtronic.com

Mary Sauline

CONTACT

mary.k.sauline@medtronic.com

Principal Investigator

Khaldoun Tarakji, MD

STUDY_DIRECTOR

Medtronic CAS Chief Medical Officer

Study Locations (Sites)

Alaska Heart Institute

Anchorage, Alaska, 99508

United States

Cardiology Associates of Fairfield County

Stamford, Connecticut, 06905-5522

United States

MedStar Washington Hospital Center

Washington, District of Columbia, 20010

United States

BayCare Medical Group Cardiology

Clearwater, Florida, 33756

United States

Heart Rhythm Solutions

Davie, Florida, 33328

United States

Iowa Heart

West Des Moines, Iowa, 50266

United States

Our Lady of the Lake

Baton Rouge, Louisiana, 70808

United States

Southcoast Health System

North Dartmouth, Massachusetts, 02747

United States

Henry Ford Heart & Vascular

Detroit, Michigan, 48202-2608

United States

The Lindner Research Center

Cincinnati, Ohio, 45219

United States

Stern Cardiovascular Foundation

Germantown, Tennessee, 38138

United States

University of Tennessee Methodist Physicians

Memphis, Tennessee, 38104-6638

United States

Texas Health Research and Education Institute

Dallas, Texas, 75231

United States

Collaborators and Investigators

Sponsor: Medtronic Cardiac Rhythm and Heart Failure

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 Date2022-04-28

Study Completion Date2028-01

Study Record Updates

Study Start Date2022-04-28

Study Completion Date2028-01

Terms related to this study

Additional Relevant MeSH Terms

Paroxysmal Atrial Fibrillation