CORCYM Mitral, Aortic aNd Tricuspid Post-maRket Study in... | NCT05002543

Status Module

Description Module

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.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MANTRA Aortic Sub-study		Subjects diagnosed with aortic valve disease who are considered suitable to undergo aortic valve replacement with a CORCYM device can be included in this study. The following devices can be entered in the study: Tissue Valve: Perceval® PLUS SUTURELESS AORTIC HEART VALVE Perceval® S SUTURELESS AORTIC HEART VALVE Mechanical Valves: Bicarbon™ Bileaflet Heart Valve Prostheses Models: Bicarbon Fitline Aortic (LFA) Bicarbon Slimline Aortic (LSA) Bicarbon Overline Aortic (LOV) Carbomedics Prosthetic Heart Valve Models: Standard Aortic Valve Reduced Aortic Valve Supra-Annular Aortic Valve (Top Hat) Orbis™ Aortic Valve Ascending Aorta Prostheses CARBOMEDICS-CARBO-SEAL™ CARBOMEDICS CARBO-SEAL™ VALSALVA
MANTRA Mitral/Tricuspid Sub-study		Subjects diagnosed with mitral and/or tricuspid valve disease who are considered suitable to undergo mitral valve repair/replacement and/or tricuspid valve repair with a CORCYM device can be included in this study. The following devices can be entered in the study: Annuloplasty Rings: SOVERING™ ANNULOPLASTY DEVICE models annuloplasty ring, mitral model annuloplasty band, mitral and tricuspid models Carbomedics Annuloplasty Ring models: CARBOMEDICS ANNULOFLO® CARBOMEDICS ANNULOFLEX® Memo Annuloplasty Ring o MEMO 3D™ SEMIRIGID ANNULOPLASTY RING Mitral Valves: Bicarbon™ Bileaflet Heart Valve Prostheses Models: o Bicarbon Fitline Mitral (LFM) Carbomedics Prosthetic Heart Valve Models: Standard Mitral Valve Orbis™ Mitral Valve OptiForm® Mitral Valve
MANTRA Memo 4D Sub-study		Subjects diagnosed with mitral valve disease who are considered suitable to undergo mitral valve repair with a CORCYM Memo 4D annuloplasty ring can be included in this study.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
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
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.

Secondary Outcomes

Measure	Description	Time Frame
Mortality (all-cause mortality, cardiovascular mortality, device related mortality)	Number of patients with this event	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)

Eligibility Module

Name	Role	Phone	Extension	Email
Silvia Dipinto	Contact	+39 346 1284042		silvia.dipinto@corcym.com
Michela Paroli	Contact	+39 348		michela.paroli@corcym.com

Name	Affiliation	Role
Sara Gaggianesi	Corcym S.r.l	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
St. Vincent Heart Center of Indiana	Recruiting	Indianapolis	Indiana	46290	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
42236299	Derived	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, Nobre A. Sex-Related Outcome After Sutureless Aortic Valve Replacement With Perceval Plus: Results From a Global Registry and Meta-Regression. Interdiscip Cardiovasc Thorac Surg. 2026 Jun 9;41(6):ivag170. doi: 10.1093/icvts/ivag170.
39666948

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases