Clinical trial NCT05002543: CORCYM Mitral, Aortic aNd Tricuspid Post-maRket Study in a reAl-world Setting
Official title: CORCYM Mitral, Aortic aNd Tricuspid Post-maRket Study in a reAl-world Setting
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Valve Disease
Keywords: Aortic Valve Replacement
Mitral Valve Replacement
Mitral Valve Repair
Tricuspid Valve Repair
Lead sponsor: Corcym S.r.l
Sponsor class: INDUSTRY
First posted: 2021-08-12
Enrollment: 2150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects diagnosed with heart valve disease who are considered suitable to undergo heart valve replacement/repair with a CORCYM device can be included

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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)

Primary outcomes:
measure: The primary endpoint in the AORTIC Sub-study is number and percentage of subjects with Device Success
timeFrame: 30 days
measure: The primary endpoint in the MITRAL/TRICUSPID Sub-study is number and percentage of subjects with Device Success
timeFrame: 30 days
measure: The primary endpoint in the MEMO 4D Sub-study is number and percentage of subjects with Device Success
timeFrame: 30 days
Secondary outcomes:
measure: Mortality (all-cause mortality, cardiovascular mortality, device related mortality)
timeFrame: up to 10 years from implant
measure: Major Adverse Cardiovascular and Cerebrovascular Event (MACCE - composite endpoint of all cause death, myocardial infarction, stroke, and valve re-intervention)
timeFrame: up to 10 years from implant
measure: Re-hospitalization (all-cause re-hospitalization, cardiovascular re-hospitalization, device related re-hospitalization)
timeFrame: up to 10 years from implant
measure: Technical success
timeFrame: intraoperatively
measure: Clinical Efficacy (AORTIC sub-study)
timeFrame: 12 months
measure: Valve-related long-term clinical efficacy
timeFrame: at 5 years and up to 10 years
measure: Bioprosthetic Valve Dysfunction (BVD), including Structural Valve Deterioration (SVD), Non structural valve dysfunction (NSVD), Thrombosis and Endocarditis
timeFrame: up to 10 years from implant
measure: Patient outcome (Kansas City Cardiomyopathy Questionnaire (KCCQ-12); and EQ-5D-5L (in patients treated with Perceval Plus)
timeFrame: 12 months
measure: Patient outcome (New York Heart Association (NYHA) Classification)
timeFrame: up to 10 years from implant
measure: Hemodynamic and structural performance
timeFrame: up to 10 years from implant
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: St. Vincent Heart Center of Indiana
state: Indiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Institute for Medical Research
state: Pennsylvania
city: Innsbruck
country: Austria
facility: Innsbruck Medical University
city: Genk
country: Belgium
facility: Ziekenhuis Oost Limburg
city: Gent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
facility: UZ Leuven
city: Calgary
country: Canada
facility: University of Calgary (Foothills Hospital)
city: Québec
country: Canada
facility: Hospital Laval IUCPQ
city: Toronto
country: Canada
facility: St. Michael's Hospital
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand_Hopital Gabriel Montpied
city: Lens
country: France
facility: Centre Hospitalier de Lens
city: Poitiers
country: France
facility: CHU Poitiers
city: Toulouse
country: France
facility: CHU Toulouse_Rangueil University Hospital
city: Augsburg
country: Germany
facility: Universitätsklinikum Augsburg
city: Bad Nauheim
country: Germany
facility: Kerckhoff Klinik
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin
city: Dresden
country: Germany
facility: Herzzentrum Dresden Universitätsklinik
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Magdeburg
country: Germany
facility: Universitätsklinikum Magdeburg
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg GGMBH AöR
city: Ancona
country: Italy
facility: Ospedale Riuniti Ancona
city: Bologna
country: Italy
facility: Policlinico S.Orsola-Malpighi
city: Brescia
country: Italy
facility: Fondazione Poliambulanza Istituto Ospedaliero
city: Lecce
country: Italy
facility: Ospedale Città di Lecce
city: Massa
country: Italy
facility: Ospedale del Cuore "G. Pasquinucci"
city: Milan
country: Italy
facility: IRCCS Policlinico San Donato
city: Napoli
country: Italy
facility: Azienda ospedaliera dei Colli - Ospedale Monaldi
city: Palermo
country: Italy
facility: Policlinico Paolo Giaccone
city: Torino
country: Italy
facility: A.O.U. Citta della Salute e della Scienza di Torino - Ospedale Molinette
city: Treviso
country: Italy
facility: Ospedale Cà Foncello di Treviso
city: Trieste
country: Italy
facility: Az. Ospedaliero-Universitaria "Ospedali Riuniti" di Trieste
city: Vicenza
country: Italy
facility: Ospedale San Bortolo
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Severance Cardiovascular Hospital
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Groningen
country: Netherlands
facility: UMC Groningen
city: Lisboa
country: Portugal
facility: Hospital de Santa Maria Lisbon
city: Belgrade
country: Serbia
facility: Dedinje Cardiovascular Institute
city: Bern
country: Switzerland
facility: Inselspital, Universitätsspital Bern
city: Zürich
country: Switzerland
facility: Stadtspital Triemli
city: Birmingham
country: United Kingdom
facility: Queen Elisabeth Medical Centre
city: Bristol
country: United Kingdom
facility: Bristol Royal Infirmary
city: London
country: United Kingdom
facility: King's College Hospital
Study officials:
affiliation: Corcym S.r.l
name: Sara Gaggianesi
role: STUDY_DIRECTOR
References: