BaLloon-based PFA Ablation poST Approval Outcomes for PAF and PersAF
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbbott Medical Devices
About this trial
This study is designed to obtain real-world clinical evidence on the safety and effectiveness of the Volt PFA System in various use cases, with a sub study designed to address additional clinical evidence needs in electrophysiology.
Eligibility criteria
Qualifiers
Physician's note indicating recurrent self-terminating AF AND
One electrocardiographically documented PAF episode within 12 months prior to enrollment.
Physician's note, AND either
24-hour Holter within 360 days prior to enrollment, showing continuous AF, OR
Disqualifiers
Arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, electrolyte imbalance, severe untreated sleep apnea, and other major surgical procedures in the preceding 90 days
Known presence of cardiac thrombus
Known Left ventricular ejection fraction < 35% as assessed with echocardiography within 360 days of index procedure
New York Heart Association (NYHA) class III or IV heart failure
Trial design
Treatments tested in this trial
- Pulsed Field Ablation
Treatment groups
300 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov