| NCT ID | NCT06578104 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medtronic Cardiac Ablation Solutions |
| Condition | Atrial Fibrillation |
| Study Type | OBSERVATIONAL |
| Enrollment | 580 participants |
| Start Date | 2024-11-04 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 580 participants in total. It began in 2024-11-04 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Khaldoun Tarakji, MD
STUDY DIRECTOR
Medtronic CAS Chief Medical Officer
Frequently Asked Questions
Who can join the NCT06578104 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06578104 currently recruiting?
Yes, NCT06578104 is actively recruiting participants. Contact the research team at josman.suri@medtronic.com for enrollment information.
Where is the NCT06578104 trial being conducted?
This trial is being conducted at Tampa, United States, Atlanta, United States, Chicago, United States, Whitesburg, United States and 11 additional locations.
Who is sponsoring the NCT06578104 clinical trial?
NCT06578104 is sponsored by Medtronic Cardiac Ablation Solutions. The principal investigator is Khaldoun Tarakji, MD at Medtronic CAS Chief Medical Officer. The trial plans to enroll 580 participants.
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