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

Area of Science:

• Cardiology
• Medical Devices
• Digital Health

Background:

• Limited real-time tailoring of antitachycardia pacing (ATP) and early identification of heart failure (HF) risk hinder implantable defibrillation device efficacy.
• The Personalized Therapy study addresses these barriers using novel algorithms.

Purpose of the Study:

• To evaluate the real-world performance of intrinsic ATP (iATP) and TriageHF algorithms.
• To assess the ability of iATP to tailor antitachycardia pacing and TriageHF to identify patients at risk for heart failure events.

Main Methods:

• Prospective, multicenter, post-market registry study.
• Enrollment of approximately 2200 patients with study-eligible devices, enrolled in the Medtronic CareLink Network.
• Evaluation of iATP and TriageHF algorithms, with TriageHF High-Risk Alerts enabled.

Main Results:

• Primary objectives include demonstrating iATP effectiveness in the fast ventricular tachycardia zone.
• Estimation of the positive predictive value of TriageHF high-risk status for worsening HF.
• Characterization of iATP effectiveness across all ventricular detection zones and TriageHF-based clinical actions.

Conclusions:

• The study is expected to provide real-world evidence on iATP and TriageHF algorithm performance.
• These algorithms aim to enhance clinical practice by personalizing arrhythmia and HF therapies.