PULSED AF Post-Approval Study

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.

Conditions

Atrial Fibrillation

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Study Overview

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Study Details

Study overview

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.

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

PULSED AF Post-Approval Study

Condition
Atrial Fibrillation
Intervention / Treatment

-

Contacts and Locations

New York

Northwell Health Lenox Hill Hospital, New York, New York, United States, 10075

Doylestown

Doylestown Health Cardiology a division of Doylestown Health Physicians, Doylestown, Pennsylvania, United States, 18901-2554

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

  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Medtronic Cardiac Rhythm and Heart Failure,

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

Study Record Dates

2029-06-01