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

NCT ID: NCT04798768

Last Updated: 2025-11-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 297 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-20
• Study Completion Date: 2030-12-31

Brief Summary

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

Detailed Description

The MODULAR ATP Clinical Study will enroll subjects with a standard Implantable Cardioverter Defibrillator (ICD) indication applying international practice guidelines, as well as those who already have an implanted S-ICD System and satisfy the inclusion criteria for this study, while not meeting any exclusion criteria. Subjects will be followed for at least 6 months following mCRM Therapy System implantation.

Conditions

Tachycardia, Ventricular; Arrhythmia, Ventricular

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MODULAR ATP Study Participants

All subjects that signed the informed consent were included.

Patients consented to receive the mCRM Therapy System which consists of the EMPOWER Leadless Pacemaker and an EMBLEM S-ICD upgraded with investigational firmware.

Group Type: EXPERIMENTAL

mCRM Therapy System

Intervention Type: DEVICE

Communication testing between S-ICD and LCP in 4 body postures as well as required electrical testing.

Interventions

mCRM Therapy System

Communication testing between S-ICD and LCP in 4 body postures as well as required electrical testing.

Intervention Type: DEVICE

Other Intervention Names

Communication of S-ICD to Leadless Cardiac Pacemaker (LCP)

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Lloyd, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Reinoud Knops, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Amsterdam University Medical Centre

Lluis Mont, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic, University of Barcelona

Vivek Reddy, MD

Role: PRINCIPAL_INVESTIGATOR

The Mount Sinai Hospital

Locations

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

Hospital European Georges-Pompidou

Paris, , France

Spedali Civil di Brescia

Brescia, , Italy

Maria Cecilia Hospital SPA

Cotignola, , Italy

AZ Osp Monaldi

Napoli, , Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, , Italy

Amsterdam University Medical Center

Amsterdam, , Netherlands

St. Antonius Ziekenhuis

Nieuwegein, , Netherlands

Erasmus MC University Medical Center

Rotterdam, , Netherlands

Hospital Clinic of Barcelona

Barcelona, , Spain

The General Infirmary

Leeds, , United Kingdom

Liverpool Heart and Chest Hospital

Liverpool, , United Kingdom

Manchester Heart Center

Manchester, , United Kingdom

Southampton University Hospital

Southampton, , United Kingdom

Countries

United States; Austria; Canada; Czechia; France; Italy; Netherlands; Spain; United Kingdom

References

Lloyd MS, Brisben AJ, Reddy VY, Blomstrom-Lundqvist C, Boersma LVA, Bongiorni MG, Burke MC, Cantillon DJ, Doshi R, Friedman PA, Gras D, Kutalek SP, Neuzil P, Roberts PR, Wright DJ, Appl U, West J, Carter N, Stein KM, Mont L, Knops RE. Design and rationale of the MODULAR ATP global clinical trial: A novel intercommunicative leadless pacing system and the subcutaneous implantable cardioverter-defibrillator. Heart Rhythm O2. 2023 Jun 2;4(7):448-456. doi: 10.1016/j.hroo.2023.05.004. eCollection 2023 Jul.

Reference Type: BACKGROUND

PMID: 37520021 (View on PubMed)

Knops RE, Lloyd MS, Roberts PR, Wright DJ, Boersma LVA, Doshi R, Friedman PA, Neuzil P, Blomstrom-Lundqvist C, Bongiorni MG, Burke MC, Gras D, Kutalek SP, Amin AK, Fu EY, Epstein LM, Tolosana JM, Callahan TD, Aasbo JD, Augostini R, Manyam H, Nair DG, Mondesert B, Su WW, Pepper C, Miller MA, Grammes J, Saleh K, Marquie C, Merchant FM, Cha YM, Cunnington C, Frankel DS, West J, Matznick E, Swackhamer B, Brisben AJ, Weinstock J, Stein KM, Reddy VY, Mont L; MODULAR ATP Investigators. A Modular Communicative Leadless Pacing-Defibrillator System. N Engl J Med. 2024 Oct 17;391(15):1402-1412. doi: 10.1056/NEJMoa2401807. Epub 2024 May 18.

Reference Type: RESULT

PMID: 38767244 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

C1907

Identifier Type: -

Identifier Source: org_study_id