Effectiviteit van het EMPOWER™ modulaire stimulatiesysteem en de EMBLEM™ subcutane ICD om antitachycardiestimulatie te communiceren (MODULAR ATP)
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
Toestand
Conditie
Conditie
Interventie / Behandeling
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
Studietype
Inschrijving (Werkelijk)
Inschrijving
Fase
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Québec, Canada
- Institut Universitaire de Cardilogie et Pnuemologie de Quebec (IUCPQ)
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Quebec
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Montreal, Quebec, Canada, H1T 1C8
- Institut de Cardiologie de Quebec (Montreal Heart)
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Grenoble, Frankrijk
- CHU Grenoble - Hospital Michallon
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Lille, Frankrijk, 59000
- CHRU de Lille
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Nantes, Frankrijk
- CHU de Nantes-Hopital Laennec
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Paris, Frankrijk
- Hospital European Georges-Pompidou
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Brescia, Italië
- Spedali Civil di Brescia
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Cotignola, Italië
- Maria Cecilia Hospital SPA
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Naples, Italië, 80131
- AZ Osp Monaldi
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Pisa, Italië, 56126
- Azienda Ospedaliero Universitaria Pisana
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Amsterdam, Nederland
- Amsterdam University Medical Center
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Nieuwegein, Nederland
- St. Antonius Ziekenhuis
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Rotterdam, Nederland, 3015 CE
- Erasmus MC University Medical Center
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Linz, Oostenrijk
- Kepler Universitaetsklinikum
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Barcelona, Spanje, 08036
- Hospital Clinic of Barcelona
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Prague, Tsjechië
- Na Homolce Hospital
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Leeds, Verenigd Koninkrijk, LS1 EX
- The General Infirmary
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Liverpool, Verenigd Koninkrijk, L14 3PE
- Liverpool Heart and Chest Hospital
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Manchester, Verenigd Koninkrijk, M13 9WL
- Manchester Heart Center
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Southampton, Verenigd Koninkrijk
- Southampton University Hospital
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Arizona
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Phoenix, Arizona, Verenigde Staten, 85006
- Banner University Medical Center Phoenix
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Scottsdale, Arizona, Verenigde Staten, 84258
- Scottsdale Healthcare - Shea
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Arkansas
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Jonesboro, Arkansas, Verenigde Staten, 72401
- Arrhythmia Research Group
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Florida
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Orlando, Florida, Verenigde Staten, 32803
- AdventHealth Orlando
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30308
- Emory University Hospital
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Kentucky
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Lexington, Kentucky, Verenigde Staten, 40503
- Baptist Health Lexington
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Minnesota
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Rochester, Minnesota, Verenigde Staten, 55905
- Mayo Clinic
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New Jersey
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Camden, New Jersey, Verenigde Staten, 08103
- Cooper Hospital - University Medical Center
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New York
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Manhasset, New York, Verenigde Staten, 11030
- Northwell University Hospital
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New York, New York, Verenigde Staten, 10029
- Mount Sinai Medical Center
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Ohio
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Cleveland, Ohio, Verenigde Staten, 44195
- Cleveland Clinic
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Columbus, Ohio, Verenigde Staten, 43210
- Ohio State University Medical Center
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Columbus, Ohio, Verenigde Staten, 43214
- Ohio Health Research Institute
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Pennsylvania
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Hershey, Pennsylvania, Verenigde Staten, 17033
- Penn State Health Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, Verenigde Staten, 19104
- Hospital of the University of Pennsylvania
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Tennessee
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Chattanooga, Tennessee, Verenigde Staten, 37403
- Erlanger Medical Center
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Virginia
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Norfolk, Virginia, Verenigde Staten, 23507
- Sentara Norfolk General
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Washington
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Seattle, Washington, Verenigde Staten, 98195
- University of Washington Medical Center
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Deelname Criteria
Geschiktheidscriteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
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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]
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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*
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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
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Patient who is age 18 years or above, or of legal age to give informed consent specific to state and national law
Exclusion Criteria:
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Patient with an ongoing complication due to Cardiac Implantable Electronic Device (CIED) infection or CIED explant
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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)
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Patient with a known LA thrombus
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Patient with a ventricular arrhythmia due to a reversible cause
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Patient indicated for implantation of a dual chamber pacemaker or cardiac resynchronization therapy (CRT)
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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
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Patient requires rate-responsive pacing therapy
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Patient is entirely pacemaker-dependent (defined as escape rhythm ≤ 30 bpm)
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Patient with Acute Coronary Syndrome (i.e. Acute Myocardial Infarction, Unstable Angina) within 40 days
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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
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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.
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Patient with known or suspected sensitivity to Dexamethasone Acetate (DXA)
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Patient with a known cardiovascular anatomy that precludes implant in the right ventricle
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Patient with a known allergy to any system components
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Patient with a known or suspected intolerance to S-ICD conversion testing, based on physician discretion
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Patient is not likely to have meaningful survival** for at least 12 months (documented or per investigator's discretion)
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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.
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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
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Aantal wapens
Wapens en interventies
Deelnemersgroep / ArmDeelnemersgroep / Arm |
Interventie / BehandelingInterventie / Behandeling |
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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:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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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
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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
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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
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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
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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
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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
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Primary Effectiveness Endpoint 2: Percentage of Subjects Classified as a Pacing Capture Threshold (PCT) Responder
Tijdsspanne: At the 6 Month Follow-up
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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
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Secundaire uitkomstmaten
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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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
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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
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Secondary Safety Endpoint
Tijdsspanne: Implant through 2 years post-implant
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All-Cause Survival; data not reported as it is still being collected |
Implant through 2 years post-implant
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Medewerkers en onderzoekers
Sponsor
Sponsor
Onderzoekers
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
Algemene publicaties
- 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.
- 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.
- 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.
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Studie start
Primaire voltooiing (Werkelijk)
Primaire voltooiing
Studie voltooiing (Geschat)
Studie voltooiing
Studieregistratiedata
Eerst ingediend
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
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Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update geplaatst
Laatste update ingediend die voldeed aan QC-criteria
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
Andere studie-ID-nummers
- C1907
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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