EMBLEM™ MRI S-ICD System

Subcutaneous Implantable Defibrillator

MODULAR ATP Clinical Study

The MODULAR ATP Clinical Study is designed to demonstrate the safety and efficacy of an individualized approach to ICD therapy that reduces many of the risks of transvenous leads while providing an option for the unknown minority of patients who may develop a need for pacing or anti-tachycardia pacing (ATP) in the future.

Key Resources

EMBLEM S-ICD Indications, Safety and Warnings

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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^* [MPS]).

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.

*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

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Want More Info About the Study?

If you have questions about the MODULAR ATP Clinical Study and patient eligibility, please contact one of the coordinating principal investigators below.

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

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

R.E. Knops, MD, PhD

Cardiologist, Department of Cardiology, Amsterdam Universitair Medische Centra, Amsterdam, the Netherlands | r.e.knops@amc.uva.nl

Dr. Vivek Y. Reddy, MODULAR ATP Clinical Study Coordinating Principal Investigator

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

The MODULAR ATP Clinical Study will enroll patients at sites in North America and Europe. If you have a patient who may be a candidate, view the active site list to find contact information for a study physician near you.

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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.

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