Objective
The purpose of the study is to describe long-term clinical performance and safety data in drug refractory, recurrent, symptomatic, paroxysmal AF and persistent AF (episode duration less than one year) patients treated with the PulseSelect™ Pulsed Field Ablation (PFA) System.
Background
Medtronic, Inc. is sponsoring the PULSED AF Post-Approval Study (PAS), which will be an addendum to the PulseSelect™ PFA Global Registry. The PULSED AF PAS is a prospective, multi-center, non-randomized observational trial.
Study Outcomes
Primary
- Estimate the 36-month freedom from AF/AFL/AT recurrence following ablation using the PulseSelect™ PFA System.
- Estimate the rate of major procedural complications for catheter ablation using the PulseSelect™ PFA System.
Secondary
- Characterize the PulseSelect™ PFA System ablation procedure
- Estimate change in quality of life (QoL) through 36 months.
- Estimate the freedom from symptomatic AF/AFL/AT recurrence through 36 months.
- Characterize all reported AEs through 36 months.
- Estimate the rate of procedure-related mortality of the AF ablation procedure using the PulseSelect™ PFA system.
- Estimate the rate of early mortality after ablation using the PulseSelect™ PFA system through 3 months post-procedure.
- Estimate the rate of cardiac arrest that occurs during or after the AF ablation procedure (index or repeat) using the PulseSelect™ PFA system through 12 months post-procedure.
- Estimate the rate of new left ventricular wall motion abnormality seen on echocardiogram at 12 months post-ablation.
- Estimate the rate of all serious device or serious procedure related adverse events for catheter ablation using the PulseSelect™ PFA System through 12 months post-procedure.
- Estimate the freedom from AF/AFL/AT recurrence post-90-day blanking period through 12 months post-ablation using the PulseSelect™ PFA System.
- Estimate the freedom from AF/AFL/AT recurrence post-90-day blanking period through 12, 24, and 36 months post-ablation using the PulseSelect™ PFA System for subjects off all Class I/III AADs.
Eligibility Criteria
The criteria below are a summary. Your study doctor will confirm whether this study is right for you.
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
About taking part
If you would like to learn more about taking part in this study, please contact our research team using the details on this page. We can walk you through what participation involves and answer any questions.