Atrial Fibrillation
Conditions
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.
Interventions
DEVICEPulseSelect™ PFA system
Ablation using the PulseSelect™ PFA system
Sponsors
Medtronic Cardiac Ablation Solutions
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy-Freedom from Atrial Fibrillation | 36-months after the index ablation procedure | Estimate the 36-month freedom from AF/AFL/AT recurrence following ablation using the PulseSelect™ PFA system. |
| Safety- Freedom from Device/Procedure Related Adverse Events | 6 months post-ablation] | Estimate the rate of major procedural complications for catheter ablation using PulseSelect™ PFA system. |
Countries
Canada, South Korea, United States
Contacts
CONTACTJosman Suri
STUDY_DIRECTORKhaldoun Tarakji, MD
Medtronic CAS Chief Medical Officer
Outcome results
None listed