Status:
RECRUITING
CORCYM Mitral, Aortic aNd Tricuspid Post-maRket Study in a reAl-world Setting
Lead Sponsor:
Corcym S.r.l
Conditions:
Cardiac Valve Disease
Eligibility:
All Genders
Brief Summary
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...
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 excellen...
Eligibility Criteria
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)
Key Trial Info
Start Date :
June 29 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2035
Estimated Enrollment :
2150 Patients enrolled
Trial Details
Trial ID
NCT05002543
Start Date
June 29 2021
End Date
December 31 2035
Last Update
March 6 2024
Active Locations (52)
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1
St. Vincent Heart Center of Indiana
Indianapolis, Indiana, United States, 46290
2
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
3
Maine Medical Center
Portland, Maine, United States, 04102
4
Duke University
Durham, North Carolina, United States, 27710