Rationale and Design of the Personalized Therapy Study: Evaluating Real-World Performance of Two Automated Defibrillation Therapy Algorithms.

Abstract

Background: Barriers to maximizing patient benefit with implantable defibrillation devices include limited ability to tailor antitachycardia pacing (ATP) therapy in real-time and identify patients at risk of heart failure (HF) events early on. The Personalized Therapy study aims to evaluate the performance of two algorithms, intrinsic ATP^TM (iATP) and TriageHF^TM, to address these barriers in routine clinical practice.

Methods and results: The Personalized Therapy Study was designed as a prospective, multicenter, post-market registry study expected to enroll approximately 2,200 patients meeting the following criteria: (1) implanted with a study-eligible device regardless of procedure type; (2) Medtronic CareLink® Network enrolled; (3) TriageHF enabled within CareLink and High Risk Alert notifications turned ON; and (4) iATP enabled. The primary study objectives are to demonstrate iATP effectiveness in the fast ventricular tachycardia zone and estimate the positive predictive value of TriageHF high-risk status for worsening HF. Additionally, objectives include characterizing iATP effectiveness in all ventricular detection zones and characterizing TriageHF based clinical actions and related HF-hospitalizations.

Conclusion: This study is expected to generate real-world evidence on the performance of the iATP and TriageHF algorithms, which aim to improve clinical practice by tailoring arrhythmia and HF therapies to individual patient disease state.