EMBLEM™ MRI S-ICD System
Subcutaneous Implantable Defibrillator
Study design and overview
The MODULAR ATP trial is a prospective, non-randomised, single arm, global study to demonstrate the safety, performance and effectiveness of the mCRM System and the EMPOWER LP and utilised performance goals to demonstrate these primary and secondary outcomes. In addition to evaluating the safety of the EMPOWER LP System, the MODULAR ATP trial evaluated the ability of the EMBLEM S-ICD to successfully communicate a wireless request to the EMPOWER LP to deliver intracardiac ATP.1,**
Specific testing was also conducted to determine the performance and effectiveness of the EMPOWER LP to function as a standalone VVIR pacemaker.2†
Not available for sale
** The mCRM wireless communication is inductive, one-way communication from the S-ID to the LP to request ATP delivery. Communication testing, which assesed pass/fail of communication at the programmed S-ICD Telemetry Setting, was required at 6-month visit in 4 body postures. The test had to pass in >88% of communication attempts, across all postures, to be defined as successful.
† Rate-response results will be reported in a future publication.
Enrollment
From July 2021 through January 2024, 293 patients were enrolled at 38 centers. The study design included a pre-specified early analysis of the safety endpoint once 134 patients were implanted with the EMBLEM S-ICD and EMPOWER LP System and followed for 6 months. Because of variability in the 6-month follow up appointments, 162 patients were in this group for this early analysis of the safety endpoint. The mean age of this group was 60 years with a mean EF of 33%. 61% had ischemic cardiomyopathy and 54% were primary prevention patients.1,8
The MODULAR ATP trial enrolled patients with significant structural heart disease and implantation of the EMPOWER LP was successful in 100% of patients.1,8
Results
Intracardiac ATP
Designed for the future of personalised patient care
Upon the EMPOWER LP and mCRM™ system receiving FDA approval, EMPOWER will be the first and only LP designed to be a standalone VVIR pacemaker that is compatible with all existing EMBLEM™ S-ICD devices as part of the mCRM system. The mCRM system is designed to deliver painless intracardiac ATP and/or brady pacing.2
Should patients currently implanted with an EMBLEM S-ICD device develop a need for ATP and/or bradycardia pacing, an upgrade pathway will be available once the EMPOWER LP and mCRM system receive FDA approval.2
The mCRM system is designed to provide upgrade pathways regardless if the EMBLEM S-ICD or EMPOWER LP is implanted first, providing physicians flexibility to tailor therapy to the individual patient's needs.2
Pacing parameters14
Pacing threshold 0.55 V at 0.4 ms
Pacing impedance 716 Ω
Sensed Amplitude 14.3 mV
Rate response14
Holter monitor sub study14, 15
APPRAISE ATP Trial
The APPRAISE ATP trial was a prospective, randomised, global, multicenter clinical trial to understand the role of ATP in primary prevention (PP) patients currently indicated for ICD therapy.
The objective of the trial was to determine if standard therapy (ATP prior to shock) is clinically equivalent to No ATP prior to shock when combined with contemporary programming in primary prevention TV-ICD indicated patients. The trial was designed to determine if programming ATP OFF in Zone 2 in PP patients is equivalent to programming ATP ON by measuring time to first all-cause shock.
Enrollment and randomisation 10,11
Results 11
The APPRAISE ATP trial demonstrated superiority with a 28% relative risk reduction in time to first all-cause shock for the ATP ON arm compared to the ATP OFF arm (Log-rank P-value=0.005). This represents an absolute all-cause shock reduction in 1% of PP ICD indicated patients per year.
There was a significant difference throughout follow up (p=0.005). The percentage of patients free from all-cause shocks at one year was 95.7% for ATP-plus-shock arm vs 94.7% for the shock-only arm.
At five years, the percent of patients free from all-cause shocks was 85.4% for the ATP-plus-shock arm vs 80.6% for the shock-only arm.11
Inappropriate shock rates low in both arms
The importance of shared decision making
Full follow-up results
Future upgrade pathway with the Modular CRM (mCRM) System*
The mCRM system is designed to provide upgrade pathways regardless if the EMBLEM S-ICD or EMPOWER LP is implanted first, providing physicians flexibility to tailor therapy to the individual patient's needs.2
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 | mlloyd2@emory.edu
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 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.