Encouraging First Clinical Data on PFA for Ventricular Arrhythmias: Affera's AVAAR Study Highlights Safety and Efficacy

Apr 07, 2025 22:15 CST Updated 22:15

Medtronic

Medical Device Manufacturer

Medtronic in European Heart RhythmAssociation (EHRA) announced regardingAffera Mapping and Ablation System TreatmentClinical Research on Ventricular Arrhythmia (AVAAR) Data, studies showAffera has demonstrated positive safety signals.

AVAAR is a prospective clinical study aimed at evaluating the safety of using the Affera device in complex ventricular arrhythmia ablation cases, involving a total of 126 procedures from 16 European centers. The primary endpoint is the incidence of complications during or within 24 hours after the procedure.

Specific Research Data

This study enrolled a patient population with "extremely critical" conditions, including approximately 80% with non-ischemic cardiomyopathy (NICM), and two-thirds of the patients underwent "reoperation."
Safety: The incidence of major acute complications during or within 24 hours after ablation was 6%, including 4 procedure-related complications and 3 "potential device-related" complications. The incidence of minor acute complications during the same period was 15%, including 5 procedure-related complications and 14 potential device-related complications.
Safety: A total of 4 deaths occurred at the 1-month follow-up time point.
Effectiveness: The proportion of patients who underwent repeat surgery and had no recurrence of ventricular arrhythmia was 68%.

PI Evaluation

"Currently, there is limited data on the optimal energy delivery strategy, and the pros and cons of pure PFA versus PFA combined with radiofrequency ablation 'remain to be determined'."The safety results of AVAAR are comparable to the published data of similar patient populations in the past, and it is further noted that no issues have been identified in the analysis to date.'With clinical consequences’ hemolysis phenomenon, but in the future, it is necessary to "closely monitor and report" stroke risks. After witnessing many significant studies on the application of PFA in the field of atrial fibrillation, it is now particularly important that we systematically advance into the field of ventricular tachycardia in patients with structural heart disease. Why is this so critical? Because for decades, we have been grappling with the extreme challenge of improving the efficacy of catheter ablation for ventricular tachycardia/fibrillation in patients with structural heart disease. We must admit that the recurrence rate remains high — especially in patients with ischemic and non-ischemic cardiomyopathy."

---Frédéric Sacher Bordeaux University Hospital

At the same time, the PI believes that despite the currentThe data is still in the preliminary stage, but these results are "encouraging." Moreover, PFA technology has officially entered the ventricular field, marking a new beginning.A New Era of Ventricular Arrhythmias.