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CORCYM MANTRA Study for Cardiac Valve Disease

This study, called MANTRA, is looking at how well CORCYM devices work and how safe they are when used to treat heart valve diseases affecting the aortic, mitral, or tricuspid valves. It's an observational study, meaning researchers will watch how these devices are used in real-world settings. The main goal is to see if the device is successfully implanted and working as intended 30 days after the procedure. You could be eligible if you need treatment with a CORCYM heart valve product and are willing to follow the study schedule. The study aims to enroll about 2150 people worldwide.

Study design
This is an observational study with approximately 2150 participants. It is designed as an umbrella protocol with multiple sub-studies looking at different CORCYM heart valve devices.
What's involved
You would need to comply with the follow-up schedule of the protocol. The study will collect safety and performance data during heart valve procedures and relevant follow-up visits.
Compensation
Not stated in the trial record.
Follow-up
The primary success of the device is measured at 30 days after the procedure.

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NCT05002543

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

Recruiting
Not specifiedAll AgesObservational
Corcym S.r.l
~2,150 participants
Updated 2024-03-06 on ClinicalTrials.gov

At a glance

Recruiting sites
47 of 52 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The primary endpoint in the AORTIC Sub-study is number and percentage of subjects with Device Success
Measured over 30 days
+2 more outcomes measured

Conditions

Cardiac Valve Disease

Explore related trials

Aortic Valve DisorderAortic Valve ReplacementCardiac Tricuspid Valve RepairMitral Valve RepairMitral Valve Replacement

Where it's being run

52 sites across 18 states
Italy12
Germany8
France4
Belgium3
Canada3
South Korea3
United Kingdom3
North Carolina2

Study leadership

  • Sara Gaggianesi · STUDY_DIRECTOR · Corcym S.r.l

Who to contact

Silvia Dipinto
[email protected]
+39 346 1284042
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • The primary endpoint in the AORTIC Sub-study is number and percentage of subjects with Device Success30 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.

  • The primary endpoint in the MITRAL/TRICUSPID Sub-study is number and percentage of subjects with Device Success30 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.

  • The primary endpoint in the MEMO 4D Sub-study is number and percentage of subjects with Device Success30 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.