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Studies

Observational Recruiting

NCT05002543 on ClinicalTrials.gov

CORCYM Mitral, Aortic aNd Tricuspid Post-maRket Study in a reAl-world Setting

  • Sponsor: Corcym S.r.l
  • Enrollment: 2150 (Estimated)
  • Study start: 2021-06-29 (Actual)
  • Primary completion: 2025-08-30 (Estimated)
  • Study completion: 2035-12-31 (Estimated)
  • Allocation: N/a
  • InterventionModel: N/a
  • Masking: None
  • PrimaryPurpose: Other

Brief Summary

MANTRA is a prospective, multiple-arm, multi-center, global, post-market clinical follow-up study. The main objective is to monitor ongoing safety and performance of the CORCYM devices and accessories used for aortic, mitral and tricuspid valvular diseases in a real-world setting.

Corcym S.r.l., is a medical device manufacturer with a broad product portfolio for cardiac surgeons, offering solutions for the treatment of aortic, mitral and tricuspid valve disease.

The MANTRA Master Plan (Master Protocol) is intended as an overarching Umbrella Protocol that allows multiple sub-studies to be added, as needed. The Umbrella Master Protocol concept offers an excellent solution to provide post-marketing clinical follow-up information on the entire cardiac surgery heart valve portfolio of the sponsor in a common database, including corelab assessment of hemodynamic and structural performance, annular motion and Dynamics for one of the products.

Currently, three sub-studies are planned:

* MANTRA - Aortic Sub-Study
* MANTRA - Mitral/Tricuspid Sub-Study (Excluding Memo 4D)
* MANTRA - Memo 4D Sub-Study

Conditions

  • Cardiac Valve Disease

Primary Outcome Measures

  • The primary endpoint in the AORTIC Sub-study is number and percentage of subjects with Device Success (30 days)
    Device success at 30 days (+14 days) based on VARC-3, defined as: * Technical success * Freedom from mortality * Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication * Intended performance of the valve (mean gradient\<20 mmHg and less than moderate aortic regurgitation) The number and percentage of subjects with device success at 30 days as per VARC-3 definition, along with individual component of the success, will be presented.
  • The primary endpoint in the MITRAL/TRICUSPID Sub-study is number and percentage of subjects with Device Success (30 days)
    Device success at 30 days (+14 days) based on MVARC, defined as: * Procedural mortality or stroke AND * Proper placement and positioning of the device AND * Freedom from unplanned surgical or interventional procedures related to the device or access procedure AND * Continued intended safety and performance of the device, including: * Evidence of structural or functional failure * Specific device-related technical failure issues and complications * MITRAL: Reduction of Mitral Regurgitation (MR) to either optimal or acceptable levels (site-reported) * TRICUSPID: Reduction of Tricuspid Regurgitation (TR) to either optimal or acceptable levels (site-reported) Number and percentage of subjects with device success, along with individual component, will be presented.
  • The primary endpoint in the MEMO 4D Sub-study is number and percentage of subjects with Device Success (30 days)
    Device success at 30 days (+14 days) based on the MVARC, defined as: * Procedural mortality or stroke; AND * Proper placement and positioning of the device; AND * Freedom from unplanned surgical or interventional procedures related to the device or access procedure; AND * Continued intended safety and performance of the device, including: * Evidence of structural or functional failure * Specific device-related technical failure issues and complications * Reduction of Mitral Regurgitation (MR) to either optimal or acceptable levels without significant mitral stenosis (i.e., post-procedure EOA is ≥ 1.5 cm2 with a transmitral gradient \<5 mmHg), and with no greater than mild MR core-lab assessed The number and percentage of subjects with device success at 30 days as per MVARC definition, along with individual component of the success, will be presented.

Countries

Austria, Belgium, Canada, France, Germany, Italy, Korea, Republic of, Netherlands, Portugal, Serbia, Switzerland, United Kingdom, United States

Locations and Investigators

  • St. Vincent Heart Center of Indiana, Indianapolis, United States (Recruiting)
    • David Heimansohn
  • Ochsner Clinic Foundation, New Orleans, United States (Recruiting)
    • Eugene Parrino
  • Maine Medical Center, Portland, United States (Withdrawn)
  • Duke University, Durham, United States (Recruiting)
    • G. Chad Hughes
  • East Carolina University, Greenville, United States (Recruiting)
    • Michael Bates
  • University Hospitals Cleveland, Cleveland, United States (Recruiting)
    • Christian Baeza
  • Cleveland Clinic, Cleveland, United States (Recruiting)
    • Eric Roselli
  • University of Pennsylvania, Philadelphia, United States (Recruiting)
    • Joseph Bavaria
  • Lankenau Institute for Medical Research, Wynnewood, United States (Active not recruiting)
  • Innsbruck Medical University, Innsbruck, Austria (Recruiting)
    • Nikolaos Bonaros
  • Ziekenhuis Oost Limburg, Genk, Belgium (Recruiting)
    • Herbert Gutermann
  • UZ Gent, Gent, Belgium (Recruiting)
    • Thierry Bové
  • UZ Leuven, Leuven, Belgium (Recruiting)
    • Bart Meuris
  • University of Calgary (Foothills Hospital), Calgary, Canada (Recruiting)
    • William Kent
  • Hospital Laval IUCPQ, Québec, Canada (Recruiting)
    • Pierre Voisine
  • St. Michael's Hospital, Toronto, Canada (Recruiting)
    • Gianluigi Bisleri
  • CHU Clermont-Ferrand_Hopital Gabriel Montpied, Clermont-Ferrand, France (Active not recruiting)
  • Centre Hospitalier de Lens, Lens, France (Recruiting)
    • Olivier Fabre
  • CHU Poitiers, Poitiers, France (Recruiting)
    • Pierre Corbi
  • CHU Toulouse_Rangueil University Hospital, Toulouse, France (Recruiting)
    • Bertrand Marcheix
  • Universitätsklinikum Augsburg, Augsburg, Germany (Active not recruiting)
  • Kerckhoff Klinik, Bad Nauheim, Germany (Recruiting)
    • Yeong-Hoon Choi
  • Deutsches Herzzentrum Berlin, Berlin, Germany (Recruiting)
    • Jörg Kempfert
  • Herzzentrum Dresden Universitätsklinik, Dresden, Germany (Recruiting)
    • Utz Kappert
  • Universitätsklinikum Essen, Essen, Germany (Recruiting)
    • Sharaf-Eldin Shehada
  • Universitätsklinikum Magdeburg, Magdeburg, Germany (Recruiting)
    • George Awad
  • Klinikum Nürnberg, Nürnberg, Germany (Recruiting)
    • Francesco Pollari
  • Klinikum Oldenburg GGMBH AöR, Oldenburg, Germany (Recruiting)
    • Friedrich Mellert
  • Ospedale Riuniti Ancona, Ancona, Italy (Recruiting)
    • Marco Di Eusanio
  • Policlinico S.Orsola-Malpighi, Bologna, Italy (Recruiting)
    • Davide Pacini
  • Fondazione Poliambulanza Istituto Ospedaliero, Brescia, Italy (Recruiting)
    • Giovanni Troise
  • Ospedale Città di Lecce, Lecce, Italy (Recruiting)
    • Giuseppe Santarpino, MD
  • Ospedale del Cuore "G. Pasquinucci", Massa, Italy (Recruiting)
    • Marco Solinas
  • IRCCS Policlinico San Donato, Milan, Italy (Recruiting)
    • Francesco Grimaldi
  • Azienda ospedaliera dei Colli - Ospedale Monaldi, Napoli, Italy (Recruiting)
    • Micheke Torella
  • Policlinico Paolo Giaccone, Palermo, Italy (Recruiting)
    • Vincenzo Argano
  • A.O.U. Citta della Salute e della Scienza di Torino - Ospedale Molinette, Torino, Italy (Recruiting)
    • Mauro Rinaldi
  • Ospedale Cà Foncello di Treviso, Treviso, Italy (Recruiting)
  • Az. Ospedaliero-Universitaria "Ospedali Riuniti" di Trieste, Trieste, Italy (Recruiting)
    • Enzo Mazzaro
  • Ospedale San Bortolo, Vicenza, Italy (Recruiting)
    • Loris Salvador
  • Seoul National University Hospital, Seoul, Korea, Republic of (Recruiting)
    • Jae Woong Choi
  • Yonsei University Severance Cardiovascular Hospital, Seoul, Korea, Republic of (Recruiting)
    • Seung Hyun Lee
  • Pusan National University Yangsan Hospital, Yangsan, Korea, Republic of (Recruiting)
    • Hyung Gon Je
  • Catharina Ziekenhuis, Eindhoven, Netherlands (Recruiting)
    • Kayan Lam
  • UMC Groningen, Groningen, Netherlands (Active not recruiting)
  • Hospital de Santa Maria Lisbon, Lisboa, Portugal (Recruiting)
    • Angelo Nobre
  • Dedinje Cardiovascular Institute, Belgrade, Serbia (Recruiting)
    • Slobodan Micovic
  • Inselspital, Universitätsspital Bern, Bern, Switzerland (Recruiting)
    • Matthias Siepe
  • Stadtspital Triemli, Zürich, Switzerland (Recruiting)
  • Queen Elisabeth Medical Centre, Birmingham, United Kingdom (Recruiting)
    • Moninder Bhabra

And 2 other sites.

Study Officials

  • Sara Gaggianesi (Study Director) — Corcym S.r.l