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
Qualifiers
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 design
Treatments tested in this trial
- Not listed
Trial groups
2,150 Participants
are grouped into 3 trial groupsSponsors and collaborators
Source ClinicalTrials.gov