EMBLEM™ MRI S-ICD System
Subcutaneous Implantable Defibrillator
About the Study
Objective
The MODULAR ATP Clinical Study is designed to demonstrate the safety, performance and effectiveness of the mCRM™ Modular CRM System (EMBLEM™ S-ICD System and EMPOWER™ Modular Pacing System).
Study Design
A prospective, non-randomized, multi-site, single-arm, global study utilizing performance goals to demonstrate safety, performance, and effectiveness of the EMPOWER MPS and mCRM Modular Therapy System.
Safety Endpoints
Safety Endpoint 1
Major EMPOWER MPS and procedure-related complication-free rate from implant through 6 months post-implant
Safety Endpoint 2
Major EMPOWER MPS and procedure-related complication-free rate from implant through 12 months post-implant
Secondary Safety Endpoint
All-Cause Survival from Implant through 2 Years Post-Implant
Effectiveness Endpoints
Primary Effectiveness Endpoint 1
Communication success between the S-ICD and EMPOWER LP at the 6-month visit
Primary Effectiveness Endpoint 2
Proportion of subjects with adequate pacing capture threshold (PCT) (defined as ≤ 2 V@0.4 ms) at the 6-month visit
Secondary Effectiveness Endpoint 1
Mean metabolic-chronotropic relation (MCR) slope from the Kay-Wilkoff model at the 3-month visit
Want More Info About the Study?
Daniel Cantillon, MD, FACC, FHRS
Associate Section Head, Cardiac Electrophysiology and Pacing
Cleveland Clinic, Cleveland, OH, USA | cantild@ccf.org
Lluís Mont, MD, PhD, FEHRA
Professor of Medicine, University of Barcelona, Head of the Arrhythmia Section, Cardiovascular Institute, Hospital Clínic, Barcelona, Catalonia, Spain | lmont@clinic.cat
R.E. Knops, MD, PhD
Cardiologist, Department of Cardiology, Amsterdam University Medical Center, Amsterdam, the Netherlands | r.e.knops@amc.uva.nl
Vivek Y. Reddy, MD
Professor of Medicine in Cardiac Electrophysiology, Director of Cardiac Arrhythmia Services, The Mount Sinai Hospital, New York, NY, USA | vivek.reddy@mountsinai.org
Clinical Trial Managers
For more information about the MODULAR ATP Clinical Study, please contact the clinical trial manager for your region.
North America
Julie West, MA
julie.west@bsci.com
Europe
Ursula Appl
ursula.appl@bsci.com
Study Site Locator
Study Eligibility
Explore patient inclusion and exclusion criteria and find resources to help you refer study candidates.
Pre-Clinical Data
See the pre-clinical data evaluating the use of modular CRM technology in animal subjects.
mCRM Technology
Discover how a modular approach to ICD therapy may reduce the risks of TV leads while providing pacing if needed.