Assessment of primary prevention patients receiving an ICD - Systematic evaluation of ATP: APPRAISE ATP

Area of Science:

• Cardiology
• Electrophysiology
• Medical Devices

Background:

• The clinical utility of antitachycardia pacing (ATP) in primary prevention patients receiving implantable cardioverter-defibrillators (ICDs) is not well-established.
• Prior studies may have overestimated ATP efficacy due to including self-terminating arrhythmias or premature interventions.
• Identifying patients who benefit from ATP to prevent shocks remains a challenge.

Purpose of the Study:

• To evaluate the role of ATP in primary prevention patients indicated for ICD therapy.
• To conduct a large-scale prospective randomized controlled trial using contemporary programming parameters.
• To provide evidence-based guidance for ICD technology selection.

Main Methods:

• A global, prospective, randomized, multicenter clinical trial enrolling approximately 2600 subjects.
• Comparison of two arms: primary prevention subjects programmed with shocks only versus those programmed with standard therapy (ATP and shock).
• Primary endpoint: time to first all-cause shock, assessed by an independent physician review of device interrogation data.

Main Results:

• The APPRAISE ATP trial is designed to collect and analyze electrogram and device interrogation data.
• An Electrogram and Device Interrogation Core Laboratory will independently review data to determine primary endpoints.
• Results will be based on physician review of device interrogation data.

Conclusions:

• The study aims to provide definitive evidence on the effectiveness of ATP in primary prevention ICD patients.
• Findings will assist clinicians in choosing appropriate ICD therapies based on robust clinical endpoint data.
• The research will inform clinical decision-making for primary prevention ICD implantation across various patient profiles.