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

Обзор

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

Подробное описание

The MANTRA Master Plan (Master Protocol) is intended as an overarching Umbrella Protocol that allows multiple substudies 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.

Currently, three substudies are planned:

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

The aim of the studies assembled under the master protocol is the continued collection of safety and performance data during heart valve procedures and the relevant follow-up visits in subjects where any of the CORCYM devices and accessories are used in a real-world setting, in accordance with the IFUs, and at the discretion of the investigator.

MANTRA study is expected to enroll approximately 2150 subjects in up to 130 sites worldwide:

* Approximately 1650 subjects considered suitable for treatment with a CORCYM aortic device * Approximately 300 subjects considered suitable for treatment with a CORCYM mitral and/or tricuspid device (excluding Memo 4D) * Approximately 200 subjects considered suitable for treatment with Memo 4D

Expected enrollment duration may vary across the different projects. Subject follow-up is planned at discharge, 30 days after implantation and then annually up to 10 years. Sites can choose to participate in one or more sub-studies.

All available data shall be gathered during standard medical care.

At a minimum, the following data will be collected:

* Informed Consent * Screening/Baseline data, including demographics and medical history * Procedural data * Hospitalization and Discharge data * Follow-up data: 30 days and annually up to 10 years post procedure * Serious Adverse Event and Device Deficiencies information

As part of the study, the subject will be asked to complete quality of life questionnaire(s) at baseline, 30 days and at 1-year follow-up.

In addition, for the MEMO 4D sub-study only, an Echocardiography Core Laboratory has been appointed by the Sponsor to assess the hemodynamic and structural performance, annular motion and dynamics, and 3D echocardiogram images (transesophageal during the procedure and transthoracic during follow up) will be collected for Corelab readings.

Первичные конечные точки

• The primary endpoint in the AORTIC Sub-study is number and percentage of subjects with Device Success [Срок оценки: 30 days]
• The primary endpoint in the MITRAL/TRICUSPID Sub-study is number and percentage of subjects with Device Success [Срок оценки: 30 days]
• The primary endpoint in the MEMO 4D Sub-study is number and percentage of subjects with Device Success [Срок оценки: 30 days]

Вторичные конечные точки (10)

• Mortality (all-cause mortality, cardiovascular mortality, device related mortality) [Срок оценки: up to 10 years from implant]
• Major Adverse Cardiovascular and Cerebrovascular Event (MACCE - composite endpoint of all cause death, myocardial infarction, stroke, and valve re-intervention) [Срок оценки: up to 10 years from implant]
• Re-hospitalization (all-cause re-hospitalization, cardiovascular re-hospitalization, device related re-hospitalization) [Срок оценки: up to 10 years from implant]
• Technical success [Срок оценки: intraoperatively]
• Clinical Efficacy (AORTIC sub-study) [Срок оценки: 12 months]
• Valve-related long-term clinical efficacy [Срок оценки: at 5 years and up to 10 years]
• Bioprosthetic Valve Dysfunction (BVD), including Structural Valve Deterioration (SVD), Non structural valve dysfunction (NSVD), Thrombosis and Endocarditis [Срок оценки: up to 10 years from implant]
• Patient outcome (Kansas City Cardiomyopathy Questionnaire (KCCQ-12); and EQ-5D-5L (in patients treated with Perceval Plus) [Срок оценки: 12 months]
• Patient outcome (New York Heart Association (NYHA) Classification) [Срок оценки: up to 10 years from implant]
• Hemodynamic and structural performance [Срок оценки: up to 10 years from implant]

Критерии участия

Критерии включения

• Signed and dated approved Informed Consent
• Subject is willing and able to comply with the follow up schedule of the protocol
• Eligible for treatment with CORCYM aortic, mitral and/or tricuspid products as outlined in the applicable Instructions for Use (IFU)

Критерии исключения

• Subject is already participating to another clinical investigation that could confound the results of this clinical investigation.
• Subject has a life expectancy ≤ 12 months
• Subject has contraindications to the use of CORCYM aortic, mitral and/or tricuspid devices as outlined in the applicable Instructions For Use (IFU)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 12 центров

• Ospedale Riuniti Ancona — Ancona
• Policlinico S.Orsola-Malpighi — Bologna
• Fondazione Poliambulanza Istituto Ospedaliero — Brescia
• Ospedale Città di Lecce — Lecce
• Ospedale del Cuore "G. Pasquinucci" — Massa
• IRCCS Policlinico San Donato — Milan
• Azienda ospedaliera dei Colli - Ospedale Monaldi — Naples
• Policlinico Paolo Giaccone — Palermo
• … и ещё 4 центра

США · 9 центров

• St. Vincent Heart Center of Indiana — Indianapolis
• Ochsner Clinic Foundation — New Orleans
• Maine Medical Center — Portland
• Duke University — Durham
• East Carolina University — Greenville
• University Hospitals Cleveland — Cleveland
• Cleveland Clinic — Cleveland
• University of Pennsylvania — Philadelphia
• … и ещё 1 центр

Германия · 8 центров

• Universitätsklinikum Augsburg — Augsburg
• Kerckhoff Klinik — Bad Nauheim
• Deutsches Herzzentrum Berlin — Berlin
• Herzzentrum Dresden Universitätsklinik — Dresden
• Universitätsklinikum Essen — Essen
• Universitätsklinikum Magdeburg — Magdeburg
• Klinikum Nürnberg — Nuremberg
• Klinikum Oldenburg GGMBH AöR — Oldenburg

Франция · 4 центра

• CHU Clermont-Ferrand_Hopital Gabriel Montpied — Clermont-Ferrand
• Centre Hospitalier de Lens — Lens
• CHU Poitiers — Poitiers
• CHU Toulouse_Rangueil University Hospital — Toulouse

Бельгия · 3 центра

• Ziekenhuis Oost Limburg — Genk
• UZ Gent — Ghent
• UZ Leuven — Leuven

Канада · 3 центра

• University of Calgary (Foothills Hospital) — Calgary
• Hospital Laval IUCPQ — Québec
• St. Michael's Hospital — Toronto

South Korea · 3 центра

• Seoul National University Hospital — Seoul
• Yonsei University Severance Cardiovascular Hospital — Seoul
• Pusan National University Yangsan Hospital — Yangsan

Великобритания · 3 центра

• Queen Elisabeth Medical Centre — Birmingham
• Bristol Royal Infirmary — Bristol
• King's College Hospital — London

Нидерланды · 2 центра

• Catharina Ziekenhuis — Eindhoven
• UMC Groningen — Groningen

Швейцария · 2 центра

• Inselspital, Universitätsspital Bern — Bern
• Stadtspital Triemli — Zurich

Австрия · 1 центр

• Innsbruck Medical University — Innsbruck

Португалия · 1 центр

• Hospital de Santa Maria Lisbon — Lisbon

Сербия · 1 центр

• Dedinje Cardiovascular Institute — Belgrade

Публикации

• Santarpino G, Lorusso R, Di Mauro M, D'Anna V, Prencipe CM, Voisine P, Bisleri G, Parrino E, Bates M, Hughes GC, Roselli E, Baeza C, Heimansohn D, Bove T, Meuris B, Gutermann H, Corbi P, Pollari F, Awad G, Kappert U, Mellert F, Shehada SE, Girdauskas E, Troise G, Solinas M, Minniti G, Mazzaro E, Rinaldi M, Pacini D, Argano V, Torella M, Lam KY, Micovic S, Siepe M, Baghai M, Lee SH, Choi JW, Je HG, PMID 42236299
• Dzemali O, Rodriguez Cetina Biefer H, Di Eusanio M, Fabre O, Troise G, Bonaros N, Grimaldi F, Choi YH, Santarpino G, Baeza C, Pollari F, Marcheix B, Pacini D, Argano V, Baghai M, Bhabra M, Mazzaro E, Badano L, Kempfert J. Mitral valve repair with the semi-rigid Memo 4D annuloplasty ring: early clinical and echocardiographic outcomes from the MANTRA study. Interdiscip Cardiovasc Thorac Surg. 2024 D PMID 39666948
• Micovic S, Nobre A, Choi JW, Solinas M, Shehada SE, Torella M, Baeza C, Parrino E, Pollari F, Troise G, Kappert U, Mellert F, Je HG, Argano V, Lam KY, Rinaldi M, Gutermann H, Meuris B; MANTRA Investigators. Early outcomes of aortic valve replacement with Perceval PLUS sutureless valve: results of the prospective multicentric MANTRA study. J Cardiothorac Surg. 2024 Jun 21;19(1):340. doi: 10.1186/s1 PMID 38902742

Идентификаторы

NCT: NCT05002543 · LNH800

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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