EMBLEM™ MRI S-ICD System
Subcutaneous Implantable Defibrillator
About the trial
Objective
The MODULAR ATP clinical trial evaluated the safety, performance and effectiveness of the Modular CRM (mCRM™) System* (EMBLEM™ S-ICD System and EMPOWER™ Leadless Pacemaker* (LP)).
Study Design
A prospective, non-randomized, multi-site, single-arm, global trial utilizing performance goals to demonstrate safety, performance, and effectiveness of the EMPOWER LP and mCRM Therapy System.
*Caution: Investigational Device. Limited by US law to investigational use only. Not available for sale.
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 1
All-cause survival from Implant through 2 years post-implant
Effectiveness Endpoints
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 information about the trial?
![Michael S. Lloyd, MD, FACC, FHRS](https://www.bostonscientific.com/en-US/products/defibrillators/emblem-s-icd-system/modular-crm-system/modular-atp-clinical-study/_jcr_content/maincontent-par/image_copy_828283583_1539336028.img.llyod_desktop-1.png)
Michael S. Lloyd, MD, FACC, FHRS
Professor of Medicine, Program Director Emory EP Fellowship,
EUH Lab Director, Emory University Hospital, Atlanta, GA, USA
| mlloyd2@emory.edu
![Dr. Lluís Mont, MODULAR ATP Clinical Study Coordinating Principal Investigator](https://www.bostonscientific.com/en-US/products/defibrillators/emblem-s-icd-system/modular-crm-system/modular-atp-clinical-study/_jcr_content/maincontent-par/image_copy_828283583_58525658.img.mont_desktop.png)
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
![Dr. R.E. Knops, MODULAR ATP Clinical Study Coordinating Principal Investigator](https://www.bostonscientific.com/en-US/products/defibrillators/emblem-s-icd-system/modular-crm-system/modular-atp-clinical-study/_jcr_content/maincontent-par/image_copy_828283583_1403588080.img.knops_desktop.png)
R.E. Knops, MD, PhD
Professor of Medicine, Department of Cardiology, Amsterdam University Medical Center, Amsterdam, the Netherlands | r.e.knops@amc.uva.nl
![Dr. Vivek Y. Reddy, MODULAR ATP Clinical Study Coordinating Principal Investigator](https://www.bostonscientific.com/en-US/products/defibrillators/emblem-s-icd-system/modular-crm-system/modular-atp-clinical-study/_jcr_content/maincontent-par/image_copy_828283583_409551444.img.reddy_desktop.png)
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