PULSED AF Post-Approval Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PulseSelect™ PFA system.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
PULSED AF Post-Approval Study, an Addendum to the PulseSelect™ PFA Global Registry
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.
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.
Interventions
- Device PulseSelect™ PFA system
Ablation using the PulseSelect™ PFA system
Primary outcome measures
- Efficacy-Freedom from Atrial Fibrillation [Time frame: 36-months after the index ablation procedure]
- Safety- Freedom from Device/Procedure Related Adverse Events [Time frame: 6 months post-ablation]]
Eligibility criteria
Inclusion criteria
- A diagnosis of recurrent symptomatic paroxysmal AF or persistent AF
- Refractory to at least one Class I or III antiarrhythmic drug (i.e., not effective, not tolerated, or not desired)
- 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 catheter or surgical ablation
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 18 centers
- University of South Florida Health (USF) — Tampa
- Piedmont Heart Institute — Atlanta
- Endeavor Health Swedish Hospital — Chicago
- Pikeville Medical Center — Whitesburg
- Southcoast Health System — Fall River
- Beaumont Health System — Royal Oak
- Nebraska Medical Center — Omaha
- The Valley Hospital — New York
- … and 10 more centers
Identifiers
NCT: NCT06578104 · PULSED AF PAS