CORCYM Mitral, Aortic aNd Tricuspid Post-maRket Study in a reAl-world Setting
ConditionCardiac Valve Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorCorcym S.r.l
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial population
Subjects diagnosed with heart valve disease who are considered suitable to undergo heart valve replacement/repair with a CORCYM device can be included
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
2,150 Participants
are grouped into 3 trial groupsGroup A: MANTRA Aortic Sub-study
Group B: MANTRA Mitral/Tricuspid Sub-study
Group C: MANTRA Memo 4D Sub-study
Trial outcomes
Primary outcomes
1
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.
Time frame
30 days2
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.
Time frame
30 days3
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.
Time frame
30 daysSecondary outcomes
1
Mortality (all-cause mortality, cardiovascular mortality, device related mortality)
Number of patients with this event
Time frame
up to 10 years from implant2
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
Time frame
up to 10 years from implant3
Re-hospitalization (all-cause re-hospitalization, cardiovascular re-hospitalization, device related re-hospitalization)
Number of patients with this event
Time frame
up to 10 years from implant4
Technical success
Technical success, defined as successful delivery, correct positioning and deployment of the first intended device intraoperatively
Time frame
intraoperativelySponsors and contacts
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Source ClinicalTrials.gov