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 2 algorithms, intrinsic ATP (iATP) and TriageHF, 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 2200 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 states.