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

March 5, 2024 updated by: Corcym S.r.l

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

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

2150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary endpoint in the AORTIC Sub-study is number and percentage of subjects with Device Success
Time Frame: 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.
30 days
The primary endpoint in the MITRAL/TRICUSPID Sub-study is number and percentage of subjects with Device Success
Time Frame: 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.
30 days
The primary endpoint in the MEMO 4D Sub-study is number and percentage of subjects with Device Success
Time Frame: 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.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality (all-cause mortality, cardiovascular mortality, device related mortality)
Time Frame: up to 10 years from implant
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)
Time Frame: up to 10 years from implant
Number of patients with this event
up to 10 years from implant
Re-hospitalization (all-cause re-hospitalization, cardiovascular re-hospitalization, device related re-hospitalization)
Time Frame: up to 10 years from implant
Number of patients with this event
up to 10 years from implant
Technical success
Time Frame: intraoperatively
Technical success, defined as successful delivery, correct positioning and deployment of the first intended device intraoperatively
intraoperatively
Clinical Efficacy (AORTIC sub-study)
Time Frame: 12 months
Clinical Efficacy according to VARC-3 guidelines
12 months
Valve-related long-term clinical efficacy
Time Frame: at 5 years and up to 10 years
Valve-related long-term clinical according to VARC-3 guidelines
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
Time Frame: up to 10 years from implant
Number of patients with this event
up to 10 years from implant
Patient outcome (Kansas City Cardiomyopathy Questionnaire (KCCQ-12); and EQ-5D-5L (in patients treated with Perceval Plus)
Time Frame: 12 months
Quality of life improvement from baseline up to 12 months
12 months
Patient outcome (New York Heart Association (NYHA) Classification)
Time Frame: up to 10 years from implant
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
Hemodynamic and structural performance
Time Frame: up to 10 years from implant
Main hemodynamic parameters will be collected according to the different indications (Aortic, Mitral and Tricuspid)
up to 10 years from implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corcym S.r.l

Investigators

  • Study Director: Sara Gaggianesi, Corcym S.r.l

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 29, 2021

Primary Completion (Estimated)

August 30, 2025

Study Completion (Estimated)

December 31, 2035

Study Registration Dates

First Submitted

July 26, 2021

First Submitted That Met QC Criteria

August 4, 2021

First Posted (Actual)

August 12, 2021

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LNH800

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiac Valve Disease

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe