Efficacité du système de stimulation modulaire EMPOWER™ et du DAI sous-cutané EMBLEM™ pour communiquer la stimulation antitachycardique (MODULAR ATP)
The MODULAR ATP Clinical Study is designed to demonstrate safety, performance, and effectiveness of the Modular Cardiac Rhythm Management (mCRM) Therapy System.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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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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Barcelona, Espagne, 08036
- Hospital Clinic of Barcelona
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Grenoble, France
- CHU Grenoble - Hospital Michallon
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Lille, France, 59000
- CHRU de Lille
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Nantes, France
- CHU de Nantes-Hopital Laennec
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Paris, France
- Hospital European Georges-Pompidou
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Brescia, Italie
- Spedali Civil di Brescia
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Cotignola, Italie
- Maria Cecilia Hospital SPA
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Naples, Italie, 80131
- AZ Osp Monaldi
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Pisa, Italie, 56126
- Azienda Ospedaliero Universitaria Pisana
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Linz, L'Autriche
- Kepler Universitaetsklinikum
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Amsterdam, Pays-Bas
- Amsterdam University Medical Center
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Nieuwegein, Pays-Bas
- St. Antonius Ziekenhuis
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Rotterdam, Pays-Bas, 3015 CE
- Erasmus MC University Medical Center
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Leeds, Royaume-Uni, LS1 EX
- The General Infirmary
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Liverpool, Royaume-Uni, L14 3PE
- Liverpool Heart and Chest Hospital
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Manchester, Royaume-Uni, M13 9WL
- Manchester Heart Center
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Southampton, Royaume-Uni
- Southampton University Hospital
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Prague, Tchéquie
- Na Homolce Hospital
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Arizona
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Phoenix, Arizona, États-Unis, 85006
- Banner University Medical Center Phoenix
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Scottsdale, Arizona, États-Unis, 84258
- Scottsdale Healthcare - Shea
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Arkansas
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Jonesboro, Arkansas, États-Unis, 72401
- Arrhythmia Research Group
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Florida
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Orlando, Florida, États-Unis, 32803
- AdventHealth Orlando
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Georgia
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Atlanta, Georgia, États-Unis, 30308
- Emory University Hospital
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Kentucky
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Lexington, Kentucky, États-Unis, 40503
- Baptist Health Lexington
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Minnesota
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Rochester, Minnesota, États-Unis, 55905
- Mayo Clinic
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New Jersey
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Camden, New Jersey, États-Unis, 08103
- Cooper Hospital - University Medical Center
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New York
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Manhasset, New York, États-Unis, 11030
- Northwell University Hospital
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New York, New York, États-Unis, 10029
- Mount Sinai Medical Center
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Ohio
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Cleveland, Ohio, États-Unis, 44195
- Cleveland Clinic
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Columbus, Ohio, États-Unis, 43210
- Ohio State University Medical Center
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Columbus, Ohio, États-Unis, 43214
- Ohio Health Research Institute
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Pennsylvania
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Hershey, Pennsylvania, États-Unis, 17033
- Penn State Health Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, États-Unis, 19104
- Hospital of the University of Pennsylvania
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Tennessee
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Chattanooga, Tennessee, États-Unis, 37403
- Erlanger Medical Center
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Virginia
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Norfolk, Virginia, États-Unis, 23507
- Sentara Norfolk General
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Washington
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Seattle, Washington, États-Unis, 98195
- University of Washington Medical Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Safety Endpoint 1: Percentage of Subjects Without Major EMPOWER MPS System- or Procedure-Related Complications Through 6 Months
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Secondary Effectiveness Endpoint: Subject-specific Slope of EMPOWER PG Sensor-Indicated Rate to the Subject's Workload on Treadmill Test
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Reinoud Knops, MD, PhD, Amsterdam University Medical Centre
- Chercheur principal: Lluis Mont, MD, PhD, Hospital Clinic, University of Barcelona
- Chercheur principal: Vivek Reddy, MD, The Mount Sinai Hospital
- Chercheur principal: Michael Lloyd, MD, Emory University
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- C1907
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
There is no plan to share IPD with other researchers in this study.
Informations sur les médicaments et les dispositifs, documents d'étude
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