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

NCT04798768 | Active Not Recruiting Results DMC FDA Device

• 1 other identifier: C1907
• Study Type: interventional
• Target: 297
• Locations: 9 countries
• Sites: 38

Brief Summary

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

Conditions

Arrhythmia, Ventricular; Tachycardia, Ventricular

Outcome Measures

Primary Outcomes (4)

• Safety Endpoint 1: Percentage of Subjects Without Major EMPOWER MPS System- or Procedure-Related Complications Through 6 Months

  Major EMPOWER MPS System- and Procedure-related Complication-Free Rate Subjects will be assessed for safety issues related to the procedure or system through 6 months post implant

  Implant through 6 Months Post-Implant

• Safety Endpoint 2: Percentage of Subjects Without Major EMPOWER MPS System- or Procedure-Related Complications Through 12 Months

  Major EMPOWER MPS System- and Procedure-related Complication-free Rate Subjects will be assessed for safety issues related to the procedure or system through 12 months post implant

  Implant through 12 Months Post-Implant

• Primary Effectiveness Endpoint 1: Percentage of Body Postures With Communication Success Between the S-ICD and EMPOWER PG

  Communication Success between the S-ICD and EMPOWER PG Data from subjects will be assessed for effectiveness of communication between S-ICD and the EMPOWER PG by evaluating if a paced beat is present during communication testing in four postures: upright, supine, and right and left side.

  At the 6 Month Follow-up

• Primary Effectiveness Endpoint 2: Percentage of Subjects Classified as a Pacing Capture Threshold (PCT) Responder

  Proportion of Subjects with Adequate Pacing Capture Threshold Effectiveness will be confirmed by evaluating the percentage of subjects considered to be a PCT Responder, defined as a subject with a PCT measurement of ≤ 2.0 V @ 0.4 ms pulse width

  At the 6 Month Follow-up

Secondary Outcomes (2)

• Secondary Effectiveness Endpoint: Subject-specific Slope of EMPOWER PG Sensor-Indicated Rate to the Subject's Workload on Treadmill Test

  At the 3 Month Visit

• Secondary Safety Endpoint

  Implant through 2 years post-implant

Study Arms (1)

MODULAR ATP Study Participants

EXPERIMENTAL

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.

Device: mCRM Therapy System

Interventions

mCRM Therapy System DEVICE

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

Also known as: Communication of S-ICD to Leadless Cardiac Pacemaker (LCP)

MODULAR ATP Study Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (38)

Banner University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

Location

Scottsdale Healthcare - Shea

Scottsdale, Arizona, 84258, United States

Location

Arrhythmia Research Group

Jonesboro, Arkansas, 72401, United States

Location

AdventHealth Orlando

Orlando, Florida, 32803, United States

Location

Emory University Hospital

Atlanta, Georgia, 30308, United States

Location

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Cooper Hospital - University Medical Center

Camden, New Jersey, 08103, United States

Location

Northwell University Hospital

Manhasset, New York, 11030, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Ohio Health Research Institute

Columbus, Ohio, 43214, United States

Location

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Erlanger Medical Center

Chattanooga, Tennessee, 37403, United States

Location

Sentara Norfolk General

Norfolk, Virginia, 23507, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Kepler Universitaetsklinikum

Linz, Austria

Location

Institut de Cardiologie de Quebec (Montreal Heart)

Montreal, Quebec, H1T 1C8, Canada

Location

Institut Universitaire de Cardilogie et Pnuemologie de Quebec (IUCPQ)

Québec, Canada

Location

Na Homolce Hospital

Prague, Czechia

Location

CHU Grenoble - Hospital Michallon

Grenoble, France

Location

CHRU de Lille

Lille, 59000, France

Location

CHU de Nantes-Hopital Laennec

Nantes, France

Location

Hospital European Georges-Pompidou

Paris, France

Location

Spedali Civil di Brescia

Brescia, Italy

Location

Maria Cecilia Hospital SPA

Cotignola, Italy

Location

AZ Osp Monaldi

Naples, 80131, Italy

Location

Azienda Ospedaliero Universitaria Pisana

Pisa, 56126, Italy

Location

Amsterdam University Medical Center

Amsterdam, Netherlands

Location

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

Location

Erasmus MC University Medical Center

Rotterdam, 3015 CE, Netherlands

Location

Hospital Clinic of Barcelona

Barcelona, 08036, Spain

Location

The General Infirmary

Leeds, LS1 EX, United Kingdom

Location

Liverpool Heart and Chest Hospital

Liverpool, L14 3PE, United Kingdom

Location

Manchester Heart Center

Manchester, M13 9WL, United Kingdom

Location

Southampton University Hospital

Southampton, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 37520021 BACKGROUND

• 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.

  PMID: 38767244 RESULT

• Lloyd MS, Reddy VY, Roberts P, Doshi RN, Wright DL, Boersma LVA, Friedman PA, Neuzil P, Blomstrom-Lundqvist C, Bongiorni MG, Burke MC, Gras D, Kutalek SP, Marijon E, Tolosana JM, Amin AK, Epstein LM, Aasbo JD, Callahan TD, Brisben AJ, West J, Matznick E, Speakman B, Bachman TN, Mont L, Knops RE. One-Year Outcomes of the MODULAR ATP Trial: A Novel Leadless Pacemaker in Wireless Communication With a Subcutaneous Implantable Cardioverter Defibrillator. Circ Arrhythm Electrophysiol. 2026 Jan;19(1):e014395. doi: 10.1161/CIRCEP.125.014395. Epub 2025 Nov 13.

  PMID: 41231774 DERIVED

MeSH Terms

Conditions

Tachycardia, Ventricular; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Tachycardia; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The study is limited by the nonrandomized design with no comparator group. Prespecified goals for safety and performance were used to define endpoints. Patients were selected with a high risk of ventricular tachycardia. The findings may not be generalizable to other patients who require S-ICDs or who have S-ICDs already implanted.

Results Point of Contact

• Title: Julie West
• Organization: Boston Scientific

Julie.West@bsci.com

651-582-4721

Study Officials

• Michael Lloyd, MD

  Emory University

  PRINCIPAL INVESTIGATOR

• Reinoud Knops, MD, PhD

  Amsterdam University Medical Centre

  PRINCIPAL INVESTIGATOR

• Lluis Mont, MD, PhD

  Hospital Clinic, University of Barcelona

  PRINCIPAL INVESTIGATOR

• Vivek Reddy, MD

  The Mount Sinai Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 15, 2021
• Study Start: July 20, 2021
• Primary Completion: May 6, 2024
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 29, 2026
• Results First Posted: June 26, 2025

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (4); ES (1); CZ (1); CA (2); NL (3); AU (1); IT (4); FR (4); US (18)