Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous ICD to Communicate Antitachycardia Pacing

Running, not enrolling · Not applicable

Conditions studied: Tachycardia, Ventricular, Arrhythmia, Ventricular

In brief

The MODULAR ATP Clinical Study is designed to demonstrate safety, performance, and effectiveness of the Modular Cardiac Rhythm Management (mCRM) Therapy System.

Key facts

Study ID: NCT04798768
Run by: Boston Scientific Corporation
People needed: 297
Starts: 2021-07-20
Expected to finish: 2030-12-31
Last updated by the study team: 2026-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patient who meets Class I, IIa, or IIb guideline ICD indications[i],[ii], or who has an existing TV-ICD[iii] or S-ICD[iv]
Patient who is deemed to be at risk for MVT based on at least ONE of the following:
History of Non-Sustained MVT with LVEF ≤ 50%
History of sustained VT/VF (secondary prevention) with LVEF ≤ 50% or significant cardiac scar*
History of syncope deemed to be arrhythmic in origin
History of ischemic cardiomyopathy with LVEF ≤35%
History of non-ischemic cardiomyopathy with LVEF ≤35% and significant scar*
Patient who is willing and capable of providing informed consent (which is not to include the use of a legally authorized representative (LAR) for documentation of informed consent) and participating in all testing associated with this investigation at an approved study site and at the intervals defined by this protocol
Patient who is age 18 years or above, or of legal age to give informed consent specific to state and national law

You may not qualify if…

Patient with an ongoing complication due to Cardiac Implantable Electronic Device (CIED) infection or CIED explant
Transvenous lead remnants within the heart from a previously implanted CIED (Note: transvenous lead remnants outside the heart (e.g., in the SVC) are allowed)
Patient with a known LA thrombus
Patient with a ventricular arrhythmia due to a reversible cause
Patient indicated for implantation of a dual chamber pacemaker or cardiac resynchronization therapy (CRT)
Patient with another implanted medical device that could interfere with implant of the leadless pacemaker, such as an implanted inferior vena cava filter or mechanical tricuspid heart valve
Patient requires rate-responsive pacing therapy
Patient is entirely pacemaker-dependent (defined as escape rhythm ≤ 30 bpm)
Patient with Acute Coronary Syndrome (i.e. Acute Myocardial Infarction, Unstable Angina) within 40 days
Inability to access femoral vein with a 21-French or larger inner diameter introducer sheath due to known anatomy condition, recent surgery, and/ or other relevant condition
Patient who has an active implanted electronic medical device intended for chronic use concomitantly with the study system, such as a left ventricular assist device (LVAD). Note that a temporary pacing wire is allowed.
Patient with known or suspected sensitivity to Dexamethasone Acetate (DXA)
Patient with a known cardiovascular anatomy that precludes implant in the right ventricle
Patient with a known allergy to any system components
Patient with a known or suspected intolerance to S-ICD conversion testing, based on physician discretion
Patient is not likely to have meaningful survival** for at least 12 months (documented or per investigator's discretion)
Patient is enrolled in any other concurrent study. Co-enrollment into other studies such as observational studies/ registries needs prior written approval by BSC. Local mandatory governmental registries are accepted for co-enrollment without approval by BSC.
Patient who is a woman of childbearing potential who is known to be pregnant at the time of study enrollment (method of assessment upon investigator's discretion)
[i]Al-Khatib, et al. 2017 AHA/ACC/HRS Guideline for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death. A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. Circulation. (2018); 138:e272-e391.
[ii] 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: The Task Force for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death of the European Society of Cardiology (ESC). European Heart Journal (2015) 36, 2793-2867.
[iii] TV-ICD system is expected to be fully explanted during or prior to full Coordinated System implant
[iv] Potential subjects with a Model 1010 S-ICD Pulse Generator are only eligible for MODULAR ATP if they are getting upgraded to Model A209, A219 or future BSC S-ICD Pulse Generator; Patients with an existing S-ICD PG subject to the electrical overstress field action are only eligible for MODULAR ATP if they are getting a new BSC Model A209 or A219, or future BSC S-ICD Pulse Generator
Significant cardiac scar is defined as a scar involving at least one ventricular myocardial segment (i.e., basal infero-septum) as identified in the official findings of a cMRI, or nuclear viability study, or echo report by the interpreting radiologist/ cardiologist who is not affiliated with the study
*meaningful survival means that a patient has a reasonable quality of life and functional status

Where it is running

Banner University Medical Center Phoenix — Phoenix, Arizona, United States
Scottsdale Healthcare - Shea — Scottsdale, Arizona, United States
Arrhythmia Research Group — Jonesboro, Arkansas, United States
AdventHealth Orlando — Orlando, Florida, United States
Emory University Hospital — Atlanta, Georgia, United States
Baptist Health Lexington — Lexington, Kentucky, United States
Mayo Clinic — Rochester, Minnesota, United States
Cooper Hospital - University Medical Center — Camden, New Jersey, United States
Northwell University Hospital — Manhasset, New York, United States
Mount Sinai Medical Center — New York, New York, United States
Cleveland Clinic — Cleveland, Ohio, United States
Ohio State University Medical Center — Columbus, Ohio, United States
Ohio Health Research Institute — Columbus, Ohio, United States
Penn State Health Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
Erlanger Medical Center — Chattanooga, Tennessee, United States
Sentara Norfolk General — Norfolk, Virginia, United States
University of Washington Medical Center — Seattle, Washington, United States
Kepler Universitaetsklinikum — Linz, Austria
Institut de Cardiologie de Quebec (Montreal Heart) — Montreal, Quebec, Canada
Institut Universitaire de Cardilogie et Pnuemologie de Quebec (IUCPQ) — Québec, Canada
Na Homolce Hospital — Prague, Czechia
CHU Grenoble - Hospital Michallon — Grenoble, France
CHRU de Lille — Lille, France
CHU de Nantes-Hopital Laennec — Nantes, France

Full record on ClinicalTrials.gov

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