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

Cardiac Valve Disease Clinical Trial

— MANTRA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05002543
• Other study ID #: LNH800
• Status: Recruiting
• Start date: June 29, 2021
• Est. completion date: December 31, 2035

Study information

• Verified date: March 2024
• Source: Corcym S.r.l
• Contact: Silvia Dipinto
• Phone: +39 346 1284042
• Email: silvia.dipinto[@]corcym.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2150
• Est. completion date: December 31, 2035
• Est. primary completion date: August 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Cardiac Valve Disease
• Heart Valve Diseases

Locations

Country	Name	City	State
Austria	Innsbruck Medical University	Innsbruck
Belgium	Ziekenhuis Oost Limburg	Genk
Belgium	UZ Gent	Gent
Belgium	UZ Leuven	Leuven
Canada	University of Calgary (Foothills Hospital)	Calgary
Canada	Hospital Laval IUCPQ	Québec
Canada	St. Michael's Hospital	Toronto
France	CHU Clermont-Ferrand_Hopital Gabriel Montpied	Clermont-Ferrand
France	Centre Hospitalier de Lens	Lens
France	CHU Poitiers	Poitiers
France	CHU Toulouse_Rangueil University Hospital	Toulouse
Germany	Universitätsklinikum Augsburg	Augsburg
Germany	Kerckhoff Klinik	Bad Nauheim
Germany	Deutsches Herzzentrum Berlin	Berlin
Germany	Herzzentrum Dresden Universitätsklinik	Dresden
Germany	Universitätsklinikum Essen	Essen
Germany	Universitätsklinikum Magdeburg	Magdeburg
Germany	Klinikum Nürnberg	Nürnberg
Germany	Klinikum Oldenburg GGMBH AöR	Oldenburg
Italy	Ospedale Riuniti Ancona	Ancona
Italy	Policlinico S.Orsola-Malpighi	Bologna
Italy	Fondazione Poliambulanza Istituto Ospedaliero	Brescia
Italy	Ospedale Città di Lecce	Lecce
Italy	Ospedale del Cuore "G. Pasquinucci"	Massa
Italy	IRCCS Policlinico San Donato	Milan
Italy	Azienda ospedaliera dei Colli - Ospedale Monaldi	Napoli
Italy	Policlinico Paolo Giaccone	Palermo
Italy	A.O.U. Citta della Salute e della Scienza di Torino - Ospedale Molinette	Torino
Italy	Ospedale Cà Foncello di Treviso	Treviso
Italy	Az. Ospedaliero-Universitaria "Ospedali Riuniti" di Trieste	Trieste
Italy	Ospedale San Bortolo	Vicenza
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Yonsei University Severance Cardiovascular Hospital	Seoul
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan
Netherlands	Catharina Ziekenhuis	Eindhoven
Netherlands	UMC Groningen	Groningen
Portugal	Hospital de Santa Maria Lisbon	Lisboa
Serbia	Dedinje Cardiovascular Institute	Belgrade
Switzerland	Inselspital, Universitätsspital Bern	Bern
Switzerland	Stadtspital Triemli	Zürich
United Kingdom	Queen Elisabeth Medical Centre	Birmingham
United Kingdom	Bristol Royal Infirmary	Bristol
United Kingdom	King's College Hospital	London
United States	Cleveland Clinic	Cleveland	Ohio
United States	University Hospitals Cleveland	Cleveland	Ohio
United States	Duke University	Durham	North Carolina
United States	East Carolina University	Greenville	North Carolina
United States	St. Vincent Heart Center of Indiana	Indianapolis	Indiana
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Maine Medical Center	Portland	Maine
United States	Lankenau Institute for Medical Research	Wynnewood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Corcym S.r.l

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint in the AORTIC Sub-study is number and percentage of subjects with Device Success	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.	30 days
Primary	The primary endpoint in the MITRAL/TRICUSPID Sub-study is number and percentage of subjects with Device Success	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.	30 days
Primary	The primary endpoint in the MEMO 4D Sub-study is number and percentage of subjects with Device Success	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.	30 days
Secondary	Mortality (all-cause mortality, cardiovascular mortality, device related mortality)	Number of patients with this event	up to 10 years from implant
Secondary	Major Adverse Cardiovascular and Cerebrovascular Event (MACCE - composite endpoint of all cause death, myocardial infarction, stroke, and valve re-intervention)	Number of patients with this event	up to 10 years from implant
Secondary	Re-hospitalization (all-cause re-hospitalization, cardiovascular re-hospitalization, device related re-hospitalization)	Number of patients with this event	up to 10 years from implant
Secondary	Technical success	Technical success, defined as successful delivery, correct positioning and deployment of the first intended device intraoperatively	intraoperatively
Secondary	Clinical Efficacy (AORTIC sub-study)	Clinical Efficacy according to VARC-3 guidelines	12 months
Secondary	Valve-related long-term clinical efficacy	Valve-related long-term clinical according to VARC-3 guidelines	at 5 years and up to 10 years
Secondary	Bioprosthetic Valve Dysfunction (BVD), including Structural Valve Deterioration (SVD), Non structural valve dysfunction (NSVD), Thrombosis and Endocarditis	Number of patients with this event	up to 10 years from implant
Secondary	Patient outcome (Kansas City Cardiomyopathy Questionnaire (KCCQ-12); and EQ-5D-5L (in patients treated with Perceval Plus)	Quality of life improvement from baseline up to 12 months	12 months
Secondary	Patient outcome (New York Heart Association (NYHA) Classification)	Change of New York Heart Association (NYHA) functional class from baseline up to 12 months after implant, and at each subsequent follow-up	up to 10 years from implant
Secondary	Hemodynamic and structural performance	Main hemodynamic parameters will be collected according to the different indications (Aortic, Mitral and Tricuspid)	up to 10 years from implant