EMBLEM™ MRI S-ICD System

Subcutaneous Implantable Defibrillator

MODULAR ATP clinical trial

The MODULAR ATP clinical trial 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. Enrollment began July 2021 and concluded in January 2024.

Key Resources

EMBLEM S-ICD Indications, Safety and Warnings

View MODULAR ATP trial results

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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

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Want more information about the trial?

If you have questions about the MODULAR ATP clinical trial 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

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

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