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

NCT04798768 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 297

Last updated 2026-05-13

Study results available
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Summary

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

Conditions

  • Tachycardia, Ventricular
  • Arrhythmia, Ventricular

Interventions

DEVICE

mCRM Therapy System

Communication testing between S-ICD and LCP in 4 body postures as well as required electrical testing.

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Michael Lloyd, MD · Emory University

  • Reinoud Knops, MD, PhD · Amsterdam University Medical Centre

  • Lluis Mont, MD, PhD · Hospital Clinic, University of Barcelona

  • Vivek Reddy, MD · The Mount Sinai Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-20
Primary Completion
2024-05-06
Completion
2030-12-31
FDA Device
Yes

Countries

  • United States
  • Austria
  • Canada
  • Czechia
  • France
  • Italy
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04798768 on ClinicalTrials.gov