ADVENT Post Approval Study

Condition(s) studied

Investigational drug(s) / intervention(s)

FARAPULSE™ Pulsed Field Ablation System: De-novo pulmonary vein isolation (PVI) will be performed with the FARAPULSE Pulsed Field Ablation (PFA) System.

Study summary

The ADVENT Post Approval Study (PAS) is a prospective, global, multicenter, observational study.

Eligibility

Primary outcome measure(s)

• Composite incidence of patients with procedure-related and device-related serious adverse events at 7-Days and 12-months post-Index Procedure. — 12 Months
  * Early Onset: Acute primary safety endpoint events, events occurring up to 7 days post-Index Procedure or hospital discharge, whichever is later including serious procedure-related and device-related adverse events. * Death * Myocardial infarction (MI) * Persistent phrenic nerve palsy * Stroke/Cerebrovascular accident (CVA) * Transient ischemic attack (TIA) * Peripheral or organ thromboembolism * Cardiac tamponade / perforation * Pericarditis * Pulmonary edema * Serious vascular access complications * Heart block * Gastric motility / pyloric spasm disorders * Severe hemolysis with subsequent renal injury or significant anemia * Late Onset: Either of the following with an onset date any time through 12-month post-Index Procedure: * Atrial esophageal fistula * Pulmonary vein stenosis (≥ 70% reduction of diameter)
• Treatment success, defined as the incidence of subjects with successful isolation of clinically relevant pulmonary veins AND patients without recurrence or interventions for AF, AFL, AT after the blanking period through 12 months. — 12 Months
  \- Acute Procedural Success: Acute procedural success is defined as isolation of all clinically relevant pulmonary veins or anatomical equivalents using the FARAPULSE Pulsed Field Ablation System only AND \- Chronic Success, defined as freedom from the following: After the Blanking Period up to the 12-Month Follow-up visit: * Occurrence of any Detectable AF, AFL, AT * ≥ 30 seconds in duration from any approved clinical recording devices considered standard of care at the study center (excluding implantable loop recorders) or * ≥ 10-second of continuous AF, AFL or AT documented on any 12-lead ECG * Following interventions: * Any cardioversion for AF, AFL or AT * Prescribed a higher dose of any failed Class I or III Antiarrhythmic Drug (AAD) documented at baseline or any new Class I or III AAD * Re-ablation for AF, AFL or AT (other than for cavotricuspid isthmus (CTI)-dependent flutter only)

Trial sites (30)