Clinical trial NCT06578104: PULSED AF Post-Approval Study
Official title: PULSED AF Post-Approval Study, an Addendum to the PulseSelect™ PFA Global Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Lead sponsor: Medtronic Cardiac Ablation Solutions
Sponsor class: INDUSTRY
First posted: 2024-08-29
Enrollment: 580
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects 18 years or older with a planned procedure using commercially available PulseSelect™ PFA System

Brief summary: 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.

Detailed description: PulseSelect is a prospective, global, multi-center, non-randomized, observational trial. Subjects will be treated with the PulseSelect™ PFA System and followed through 36 months. Study visits will occur at 3, 6, 12, 24, and 36 months post-ablation, including required 24-hour Holter monitoring at 6, 12, 24, and 36 month visits. The PulseSelect™ PFA System used in this study is market approved and the ablation procedure will be performed according to hospital standard of care.

Eligibility criteria: Inclusion 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Efficacy-Freedom from Atrial Fibrillation
timeFrame: 36-months after the index ablation procedure
measure: Safety- Freedom from Device/Procedure Related Adverse Events
timeFrame: 6 months post-ablation]
Secondary outcomes:
Other outcomes:
Locations:
city: Fall River
country: United States
facility: Southcoast Health System
state: Massachusetts
city: Omaha
country: United States
facility: Nebraska Medical Center
state: Nebraska
city: New York
country: United States
facility: The Valley Hospital
state: New York
city: New York
country: United States
facility: Northwell Health Lenox Hill Hospital
state: New York
city: Grove City
country: United States
facility: Mount Carmel Grove City Medical Center
state: Ohio
city: Doylestown
country: United States
facility: Doylestown Health Cardiology a division of Doylestown Health Physicians
state: Pennsylvania
city: Anderson
country: United States
facility: AnMed Health Center
state: South Carolina
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
Study officials:
affiliation: Medtronic CAS Chief Medical Officer
name: Khaldoun Tarakji, MD
role: STUDY_DIRECTOR
References: