EMBLEM™ MRI S-ICD System
Subcutaneous Implantable Defibrillator
MODULAR ATP Clinical Study
About the Study
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* [MPS]).
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.
*Caution: Investigational Device. Limited by US law to investigational use only. Not available for sale.
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 1
All-cause survival from Implant through 2 years post-implant
Primary Effectiveness Endpoint 1
Communication success between the S-ICD and EMPOWER leadless cardiac pacemaker 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?
Michael S. Lloyd, MD, FACC, FHRS
Professor of Medicine, Program Director Emory EP Fellowship,
EUH Lab Director, Emory University Hospital, Atlanta, GA, USA
Lluís Mont, MD, PhD, FEHRA
Professor of Medicine, University of Barcelona, Head of the Arrhythmia Section, Cardiovascular Institute, Hospital Clínic, Barcelona, Catalonia, Spain | email@example.com
R.E. Knops, MD, PhD
Cardiologist, Department of Cardiology, Amsterdam Universitair Medische Centra, Amsterdam, the Netherlands | firstname.lastname@example.org
Vivek Y. Reddy, MD
Professor of Medicine in Cardiac Electrophysiology, Director of Cardiac Arrhythmia Services, The Mount Sinai Hospital, New York, NY, USA | email@example.com
Clinical Trial Managers
For more information about the MODULAR ATP Clinical Study, please contact the clinical trial manager for your region.
Study Site Locator
Explore patient inclusion and exclusion criteria and find resources to help you refer study candidates.
See the pre-clinical data evaluating the use of modular CRM technology in animal subjects.