NCT04798768

Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous ICD to Communicate Antitachycardia Pacing

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 297 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The MODULAR ATP Clinical Study is designed to demonstrate safety, performance, and effectiveness of the Modular Cardiac Rhythm Management (mCRM) Therapy System.

Detailed description

The MODULAR ATP Clinical Study will enroll subjects with a standard Implantable Cardioverter Defibrillator (ICD) indication applying international practice guidelines, as well as those who already have an implanted S-ICD System and satisfy the inclusion criteria for this study, while not meeting any exclusion criteria. Subjects will be followed for at least 6 months following mCRM Therapy System implantation.

Conditions

• Tachycardia, Ventricular
• Arrhythmia, Ventricular

Interventions

Type	Name	Description
DEVICE	mCRM Therapy System	Communication testing between S-ICD and LCP in 4 body postures as well as required electrical testing.

Timeline

• Start date: 2021-07-20
• Primary completion: 2024-05-06
• Completion: 2030-12-31
• First posted: 2021-03-15
• Last updated: 2026-03-31
• Results posted: 2025-06-26

Locations

38 sites across 9 countries: United States, Austria, Canada, Czechia, France, Italy, Netherlands, Spain, United Kingdom

Regulatory

• FDA-regulated device study