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NCT Number: NCT05002543

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

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

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Key information

Conditions

Cardiac Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Innsbruck Medical University, Innsbruck, Austria

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Mortality (all-cause mortality, cardiovascular mortality, device related mortality)

    Time frame: up to 10 years from implant

    Number of patients with this event

  2. 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

  3. 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

  4. Technical success

    Time frame: intraoperatively

    Technical success, defined as successful delivery, correct positioning and deployment of the first intended device intraoperatively

  5. Clinical Efficacy (AORTIC sub-study)

    Time frame: 12 months

    Clinical Efficacy according to VARC-3 guidelines

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Michela Paroli

CONTACT

[email protected]

+39 348

Silvia Dipinto

CONTACT

[email protected]

+39 346 1284042

Sponsors and collaborators

Lead sponsor

Corcym S.r.l

Industry

Registry information

Acronym: MANTRA

Important dates

Study start
2021
Primary completion
2025
Study completion
2035
First posted
Aug 12, 2021
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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