RecruitingNCT06578104
PULSED AF Post-Approval Study
PULSED AF Post-Approval Study, an Addendum to the PulseSelect™ PFA Global Registry
Sponsor
Medtronic Cardiac Ablation Solutions
Enrollment
580 participants
Start Date
Nov 4, 2024
Study Type
OBSERVATIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria5
- 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 Criteria5
- 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
Interventions
DEVICEPulseSelect™ PFA system
Ablation using the PulseSelect™ PFA system
Locations(16)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06578104
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