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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
Pulsed Field Ablation
DevicePulsed Field Ablation using the Volt PFA System
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: Volt PFA Catheter Sensor Enabled (SE)Other 1 intervention
Trial outcomes
Primary outcomes
1
Rate of subjects experiencing a device and/or procedure-related serious adverse event with onset within 7 days of any ablation procedure that uses Volt AF
Serious adverse events are defined as: * Atrio-esophageal fistula * Cardiac tamponade/perforation * Death * Heart block * Myocardial infarction * Pericarditis3 * Phrenic nerve injury resulting in permanent diaphragmatic paralysis * Pulmonary Edema * Pulmonary vein stenosis1 * Stroke * Thromboembolism * Transient ischemic attack * Vagal nerve injury/gastroparesis * Major vascular access complications4 / major bleeding events5 * Device related cardiovascular and/or pulmonary adverse event that prolongs hospitalization for more than 48 hours (excluding hospitalization solely for arrhythmia recurrence or non-urgent cardioversion)
Time frame
7 days2
Long-term Effectiveness will be the proportion of subjects with freedom from documented AF/AFL/AT recurrence through 12-months.
Other situations in which subjects will be considered effectiveness endpoint failures include: * Cardioversion (electrical or pharmaceutical) for the treatment of AF/AFL/AT following the blanking period. * A second repeat procedure for ablation of AF recurrence within the 90-day blanking period * Any repeat ablation procedure in the left atrium (LA) for AF/AFL/AT following the 90-day blanking period * Any use of a new class I or III AAD for AF/AFL/AT after the 90-day blanking period * Any use of a class I or III AAD for AF/AFL/AT at a dose higher than the historical maximum dose for the subject after the blanking period.
Time frame
During procedure3
Acute procedural effectiveness is defined as confirmation of entrance block in all targeted pulmonary veins
A secondary measure of confirmation to include any one of the following (the same method must be used for all pulmonary veins) : * A minimum 20-minute wait following initial confirmation of entrance block with a second confirmation of entrance block following the 20-minute wait; or * Exit block pacing maneuvers ; or * Isoproterenol or adenosine challenge
Time frame
During procedureSponsors and contacts
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Source ClinicalTrials.gov