RECRUITING

PULSED AF Post-Approval Study

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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

PULSED AF PAS is a prospective, global, multi-center, non-randomized, observational trial. Subjects will be treated with the PulseSelect™ PFA System and followed through 36 months.

Official Title

PULSED AF Post-Approval Study, an Addendum to the PulseSelect™ PFA Global Registry

Quick Facts

Study Start:2024-11-04

Study Completion:2029-06-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06578104

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
* A diagnosis of recurrent symptomatic paroxysmal AF or persistent AF * Failure or intolerance of at least one Class I or III antiarrhythmic drug * Patient is ≥ 18 years of age * Planned pulmonary vein isolation procedure with the commercially available PulseSelect™ PFA System * Willing and able 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	* Long-standing persistent AF (continuous AF sustained \>12 months) * Prior left atrial ablation or left atrial surgical procedure * Patient with life expectancy \< 36 months * Presence of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function) * Current or anticipated participation in any other clinical trial of a drug, device, or biologic not approved by the global study manager

Inclusion Criteria

Exclusion Criteria

* A diagnosis of recurrent symptomatic paroxysmal AF or persistent AF
* Failure or intolerance of at least one Class I or III antiarrhythmic drug
* Patient is ≥ 18 years of age
* Planned pulmonary vein isolation procedure with the commercially available PulseSelect™ PFA System
* Willing and able 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

* Long-standing persistent AF (continuous AF sustained \>12 months)
* Prior left atrial ablation or left atrial surgical procedure
* Patient with life expectancy \< 36 months
* Presence of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function)
* Current or anticipated participation in any other clinical trial of a drug, device, or biologic not approved by the global study manager

Contacts and Locations

Study Contact

Ryan Radtke

CONTACT

712.941.9372

ryan.s.radtke@medtronic.com

Principal Investigator

Khaldoun Tarakji, MD

STUDY_DIRECTOR

Medtronic CAS Chief Medical Officer

Study Locations (Sites)

Northwell Health Lenox Hill Hospital

New York, New York, 10075

United States

Doylestown Health Cardiology a division of Doylestown Health Physicians

Doylestown, Pennsylvania, 18901-2554

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 Date2024-11-04

Study Completion Date2029-06-01

Study Record Updates

Study Start Date2024-11-04

Study Completion Date2029-06-01

Terms related to this study

Additional Relevant MeSH Terms

Atrial Fibrillation