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Active, not recruitingNCT04798768MODULAR ATPUpdated Oct 2, 2026Results posted

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

An interventional study of mCRM Therapy System in Tachycardia, Ventricular and Arrhythmia, Ventricular, sponsored by Boston Scientific Corporation. Active, not recruiting at 38 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.

Sponsored by Boston Scientific Corporation · Not applicable, Interventional, and Treatment

Updated Oct 2, 2026Posted results revisedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
297
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Tachycardia, Ventricular
  • Arrhythmia, Ventricular
03

In context

Tachycardia, Ventricular

431 studies on the registry are indexed under Tachycardia, Ventricular; 119 are open to participants now.

This study's enrollment of 297 is above the median of 64 across 260 interventional studies indexed under Tachycardia, Ventricular.

Browse Tachycardia, Ventricular studies →

Lead sponsor

Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.

Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
297 participants (actual)

Study arms

  • Experimental
    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.

    Device: mCRM Therapy System

Interventions

  • DevicemCRM Therapy System

    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)

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Implant through 6 Months Post-Implant

  2. 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

    Time frame: Implant through 12 Months Post-Implant

  3. 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.

    Time frame: At the 6 Month Follow-up

  4. 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

    Time frame: At the 6 Month Follow-up

Secondary outcomes

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

    Metabolic-Chronotropic Relation Slope (MCR Slope) from the Kay-Wilkoff Model Using the Kay-Wilkoff model, data will be assessed to evaluate the proportionality of the EMPOWER PG's sensor-indicated rate to the subject's workload during the treadmill test

    Time frame: At the 3 Month Visit

  2. Secondary Safety Endpoint

    All-Cause Survival; data not reported as it is still being collected

    Time frame: Implant through 2 years post-implant

07

Results

Posted Jun 26, 2025
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.

Participant flow

Participant flow — Overall Study
MilestonePatients Implanted With S-ICD and Leadless Cardiac Pacemaker
Started297
Implanted with mcrm therapy system or attempt or partial implant288
Implanted with mcrm therapy system or attempt287
Implanted with mcrm therapy system286
Interim analysis cohort162
Ce mark cohort117
Completed0
Not completed297

Outcome measures

PrimarySafety 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

Time frame:
Implant through 6 Months Post-Implant
Reported as:
Number · % of subjects free from complication
Safety Endpoint 1: Percentage of Subjects Without Major EMPOWER MPS System- or Procedure-Related Complications Through 6 Months
% of subjects free from complicationInterim Analysis Cohort
Safety Endpoint 1: Percentage of Subjects Without Major EMPOWER MPS System- or Procedure-Related Complications Through 6 Months97.5 (92.5 to NA)
PrimarySafety 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

Time frame:
Implant through 12 Months Post-Implant
Reported as:
Number · % of subjects free from complication
Safety Endpoint 2: Percentage of Subjects Without Major EMPOWER MPS System- or Procedure-Related Complications Through 12 Months
% of subjects free from complicationCE Mark Cohort
Safety Endpoint 2: Percentage of Subjects Without Major EMPOWER MPS System- or Procedure-Related Complications Through 12 Months98.3 (93.3 to NA)
PrimaryPrimary 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.

Time frame:
At the 6 Month Follow-up
Reported as:
Number · Adjusted % with successful communication
Primary Effectiveness Endpoint 1: Percentage of Body Postures With Communication Success Between the S-ICD and EMPOWER PG
Adjusted % with successful communicationInterim Analysis Cohort
Primary Effectiveness Endpoint 1: Percentage of Body Postures With Communication Success Between the S-ICD and EMPOWER PG98.8 (97.0 to NA)
PrimaryPrimary 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

Time frame:
At the 6 Month Follow-up
Reported as:
Number · % of subjects with PCT <= 2V @ 0.4 ms
Primary Effectiveness Endpoint 2: Percentage of Subjects Classified as a Pacing Capture Threshold (PCT) Responder
% of subjects with PCT <= 2V @ 0.4 msInterim Analysis Cohort
Primary Effectiveness Endpoint 2: Percentage of Subjects Classified as a Pacing Capture Threshold (PCT) Responder97.4 (93.4 to NA)
SecondarySecondary Effectiveness Endpoint: Subject-specific Slope of EMPOWER PG Sensor-Indicated Rate to the Subject's Workload on Treadmill Test

Metabolic-Chronotropic Relation Slope (MCR Slope) from the Kay-Wilkoff Model Using the Kay-Wilkoff model, data will be assessed to evaluate the proportionality of the EMPOWER PG's sensor-indicated rate to the subject's workload during the treadmill test

Time frame:
At the 3 Month Visit
Reported as:
Mean · Beta coefficient
Secondary Effectiveness Endpoint: Subject-specific Slope of EMPOWER PG Sensor-Indicated Rate to the Subject's Workload on Treadmill Test
Beta coefficientPatients Implanted With S-ICD and Leadless Cardiac Pacemaker
Secondary Effectiveness Endpoint: Subject-specific Slope of EMPOWER PG Sensor-Indicated Rate to the Subject's Workload on Treadmill Test0.96 (0.91 to 1.02)
SecondarySecondary Safety Endpoint

All-Cause Survival; data not reported as it is still being collected

Time frame:
Implant through 2 years post-implant

Results for this outcome have not been posted.

Adverse events

Collected over Entire available follow up: implant through 3.5 years to-date (median participant follow up = 1.3 years). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
MODULAR ATP Study Participants18/297 (6.1%)113/288 (39.2%)86/288 (29.9%)
Most frequent serious events
Showing 10 of 23
Most frequent serious events
EventMODULAR ATP Study Participants
TV Lead Extraction ProcedureInjury, poisoning and procedural complications2/9
CardiovascularCardiac disorders54/288
CardiovascularVascular disorders16/288
Leadless Cardiac Pacemaker - ProcedureInjury, poisoning and procedural complications13/287
Non-cardiovascularInfections and infestations13/288
Non-cardiovascularRespiratory, thoracic and mediastinal disorders12/288
Non-cardiovascularGeneral disorders10/288
S-ICD System TherapyProduct Issues9/288
Non-cardiovascularRenal and urinary disorders9/288
CardiovascularGeneral disorders7/288
Most frequent other events
Showing 10 of 18
Most frequent other events
EventMODULAR ATP Study Participants
CardiovascularCardiac disorders25/288
S-ICD System ProcedureInjury, poisoning and procedural complications16/288
Leadless Cardiac Pacemaker - ProcedureInjury, poisoning and procedural complications12/287
S-ICD System TherapyProduct Issues9/288
CardiovascularGeneral disorders8/288
Non-cardiovascularGeneral disorders4/288
CardiovascularVascular disorders4/288
S-ICD System Patient RelatedGeneral disorders2/288
S-ICD System Patient RelatedInjury, poisoning and procedural complications2/288
Modular System (LCP+S-ICD)Product Issues2/288

Baseline characteristics

Age, Continuous
Age, Continuous(Years)MODULAR ATP Study Participants
Mean59 ± 12
Sex: Female, Male
Sex: Female, Male(Participants)MODULAR ATP Study Participants
Female52
Male245
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)MODULAR ATP Study Participants
Caucasian177
Black or African American23
Asian6
American Indian or Alaska native2
Other2
Not disclosed76
Multiracial11
Region of Enrollment
Region of Enrollment(participants)MODULAR ATP Study Participants
Canada16
Netherlands12
Austria5
United States180
Czechia1
United Kingdom18
Italy15
France30
Spain20
BMI
BMI(kg/m^2)MODULAR ATP Study Participants
Mean29.7 ± 6.4
LVEF
LVEF(percent)MODULAR ATP Study Participants
Mean35.3 ± 13.1
NYHA Classification
NYHA Classification(Participants)MODULAR ATP Study Participants
Class I88
Class II146
Class III61
Class IV2
Prevention status
Prevention status(Participants)MODULAR ATP Study Participants
Primary Prevention170
Secondary Prevention127

5 further baseline measures are reported on the registry.

08

Study locations

38 sites
  • Banner University Medical Center Phoenix
    Phoenix, Arizona 85006, United States
  • Scottsdale Healthcare - Shea
    Scottsdale, Arizona 84258, United States
  • Arrhythmia Research Group
    Jonesboro, Arkansas 72401, United States
  • AdventHealth Orlando
    Orlando, Florida 32803, United States
  • Emory University Hospital
    Atlanta, Georgia 30308, United States
  • Baptist Health Lexington
    Lexington, Kentucky 40503, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • Cooper Hospital - University Medical Center
    Camden, New Jersey 08103, United States
  • Northwell University Hospital
    Manhasset, New York 11030, United States
  • Mount Sinai Medical Center
    New York, New York 10029, United States
  • Cleveland Clinic
    Cleveland, Ohio 44195, United States
  • Ohio State University Medical Center
    Columbus, Ohio 43210, United States
  • Ohio Health Research Institute
    Columbus, Ohio 43214, United States
  • Penn State Health Milton S. Hershey Medical Center
    Hershey, Pennsylvania 17033, United States
  • Hospital of the University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
  • Erlanger Medical Center
    Chattanooga, Tennessee 37403, United States
  • Sentara Norfolk General
    Norfolk, Virginia 23507, United States
  • University of Washington Medical Center
    Seattle, Washington 98195, United States
  • Kepler Universitaetsklinikum
    Linz, Austria
  • Institut de Cardiologie de Quebec (Montreal Heart)
    Montreal, Quebec H1T 1C8, 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, 59000, 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
    Naples, 80131, Italy
  • Azienda Ospedaliero Universitaria Pisana
    Pisa, 56126, Italy
  • Amsterdam University Medical Center
    Amsterdam, Netherlands
  • St. Antonius Ziekenhuis
    Nieuwegein, Netherlands
  • Erasmus MC University Medical Center
    Rotterdam, 3015 CE, Netherlands
  • Hospital Clinic of Barcelona
    Barcelona, 08036, Spain
  • The General Infirmary
    Leeds, LS1 EX, United Kingdom
  • Liverpool Heart and Chest Hospital
    Liverpool, L14 3PE, United Kingdom
  • Manchester Heart Center
    Manchester, M13 9WL, United Kingdom
  • Southampton University Hospital
    Southampton, United Kingdom
09

References and documents

Publications

  • 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. PubMed 37520021 ↗
  • 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. PubMed 38767244 ↗
  • 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. PubMed 41231774 ↗

Study documents

  • Study protocol · Apr 29, 2022
  • Statistical analysis plan · May 22, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — There is no plan to share IPD with other researchers in this study.

10

Updates

1 registry update since Sep 25, 2026
Results
Posted results revised
revised Oct 2, 2026
Show all 1 update
  1. Oct 2, 2026
    Posted results revised
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID
NCT04798768
Lead sponsor
Boston Scientific Corporation
Responsible party
Sponsor
First posted
Mar 15, 2021
Start date
Jul 20, 2021
Primary completion
May 6, 2024
Completion
Dec 31, 2030 (estimated)
Results posted
Jun 26, 2025
Last update
Oct 2, 2026

Study contacts

Michael Lloyd, MD
principal investigator · Emory University
Reinoud Knops, MD, PhD
principal investigator · Amsterdam University Medical Centre
Lluis Mont, MD, PhD
principal investigator · Hospital Clinic, University of Barcelona
Vivek Reddy, MD
principal investigator · The Mount Sinai Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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