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Effectiviteit van het EMPOWER™ modulaire stimulatiesysteem en de EMBLEM™ subcutane ICD om antitachycardiestimulatie te communiceren (MODULAR ATP)

13 oktober 2026 bijgewerkt door: Boston Scientific Corporation

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

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

297

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

      • Québec, Canada
        • Institut Universitaire de Cardilogie et Pnuemologie de Quebec (IUCPQ)
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
        • Institut de Cardiologie de Quebec (Montreal Heart)
      • Grenoble, Frankrijk
        • CHU Grenoble - Hospital Michallon
      • Lille, Frankrijk, 59000
        • CHRU de Lille
      • Nantes, Frankrijk
        • CHU de Nantes-Hopital Laennec
      • Paris, Frankrijk
        • Hospital European Georges-Pompidou
      • Brescia, Italië
        • Spedali Civil di Brescia
      • Cotignola, Italië
        • Maria Cecilia Hospital SPA
      • Naples, Italië, 80131
        • AZ Osp Monaldi
      • Pisa, Italië, 56126
        • Azienda Ospedaliero Universitaria Pisana
      • Amsterdam, Nederland
        • Amsterdam University Medical Center
      • Nieuwegein, Nederland
        • St. Antonius Ziekenhuis
      • Rotterdam, Nederland, 3015 CE
        • Erasmus MC University Medical Center
      • Linz, Oostenrijk
        • Kepler Universitaetsklinikum
      • Barcelona, Spanje, 08036
        • Hospital Clinic of Barcelona
      • Prague, Tsjechië
        • Na Homolce Hospital
      • Leeds, Verenigd Koninkrijk, LS1 EX
        • The General Infirmary
      • Liverpool, Verenigd Koninkrijk, L14 3PE
        • Liverpool Heart and Chest Hospital
      • Manchester, Verenigd Koninkrijk, M13 9WL
        • Manchester Heart Center
      • Southampton, Verenigd Koninkrijk
        • Southampton University Hospital
    • Arizona
      • Phoenix, Arizona, Verenigde Staten, 85006
        • Banner University Medical Center Phoenix
      • Scottsdale, Arizona, Verenigde Staten, 84258
        • Scottsdale Healthcare - Shea
    • Arkansas
      • Jonesboro, Arkansas, Verenigde Staten, 72401
        • Arrhythmia Research Group
    • Florida
      • Orlando, Florida, Verenigde Staten, 32803
        • AdventHealth Orlando
    • Georgia
      • Atlanta, Georgia, Verenigde Staten, 30308
        • Emory University Hospital
    • Kentucky
      • Lexington, Kentucky, Verenigde Staten, 40503
        • Baptist Health Lexington
    • Minnesota
      • Rochester, Minnesota, Verenigde Staten, 55905
        • Mayo Clinic
    • New Jersey
      • Camden, New Jersey, Verenigde Staten, 08103
        • Cooper Hospital - University Medical Center
    • New York
      • Manhasset, New York, Verenigde Staten, 11030
        • Northwell University Hospital
      • New York, New York, Verenigde Staten, 10029
        • Mount Sinai Medical Center
    • Ohio
      • Cleveland, Ohio, Verenigde Staten, 44195
        • Cleveland Clinic
      • Columbus, Ohio, Verenigde Staten, 43210
        • Ohio State University Medical Center
      • Columbus, Ohio, Verenigde Staten, 43214
        • Ohio Health Research Institute
    • Pennsylvania
      • Hershey, Pennsylvania, Verenigde Staten, 17033
        • Penn State Health Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, Verenigde Staten, 19104
        • Hospital of the University of Pennsylvania
    • Tennessee
      • Chattanooga, Tennessee, Verenigde Staten, 37403
        • Erlanger Medical Center
    • Virginia
      • Norfolk, Virginia, Verenigde Staten, 23507
        • Sentara Norfolk General
    • Washington
      • Seattle, Washington, Verenigde Staten, 98195
        • University of Washington Medical Center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.

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

Andere namen:
  • Communicatie van S-ICD naar draadloze hartpacemaker (LCP)

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Safety Endpoint 1: Percentage of Subjects Without Major EMPOWER MPS System- or Procedure-Related Complications Through 6 Months
Tijdsspanne: Implant through 6 Months Post-Implant

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
Tijdsspanne: Implant through 12 Months Post-Implant

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
Tijdsspanne: At the 6 Month Follow-up

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
Tijdsspanne: At the 6 Month Follow-up

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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Secondary Effectiveness Endpoint: Subject-specific Slope of EMPOWER PG Sensor-Indicated Rate to the Subject's Workload on Treadmill Test
Tijdsspanne: At the 3 Month Visit

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

At the 3 Month Visit
Secondary Safety Endpoint
Tijdsspanne: Implant through 2 years post-implant

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

Implant through 2 years post-implant

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Onderzoekers

  • Hoofdonderzoeker: Reinoud Knops, MD, PhD, Amsterdam University Medical Centre
  • Hoofdonderzoeker: Lluis Mont, MD, PhD, Hospital Clinic, University of Barcelona
  • Hoofdonderzoeker: Vivek Reddy, MD, The Mount Sinai Hospital
  • Hoofdonderzoeker: Michael Lloyd, MD, Emory University

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

20 juli 2021

Primaire voltooiing (Werkelijk)

6 mei 2024

Studie voltooiing (Geschat)

31 december 2030

Studieregistratiedata

Eerst ingediend

8 maart 2021

Eerst ingediend dat voldeed aan de QC-criteria

12 maart 2021

Eerst geplaatst (Werkelijk)

15 maart 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

15 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

13 oktober 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • C1907

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

There is no plan to share IPD with other researchers in this study.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .