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NCT05002543 · ClinicalTrials.gov registry record
CORCYM Mitral, Aortic aNd Tricuspid Post-maRket Study in a reAl-world Setting
A clinical trial of Cardiac Valve Disease, sponsored by Corcym S.r.l.
- Recruiting
- Registry status
- 2,150
- Enrollment target
- 20
- Study locations
NCT05002543: Recruiting study of Cardiac Valve Disease, sponsored by Corcym S.r.l.
NCT05002543 is a study of Cardiac Valve Disease that is actively recruiting participants, run by Corcym S.r.l. The registered enrollment target is 2,150 participants. The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05002543, a study of Cardiac Valve Disease, is actively recruiting participants, sponsored by Corcym S.r.l.
- RECRUITING
- Registry status
- 2,150 participants
- Enrollment target
- 20
- Study locations
Study 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 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
Primary Outcome
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, wi
Conditions Studied
Study Locations (20)
Other
- Innsbruck Medical University - Innsbruck
- Ziekenhuis Oost Limburg - Genk
- UZ Gent - Ghent
- UZ Leuven - Leuven
- University of Calgary (Foothills Hospital) - Calgary
- Hospital Laval IUCPQ - Québec
- St. Michael's Hospital - Toronto
- CHU Clermont-Ferrand_Hopital Gabriel Montpied - Clermont-Ferrand
- Centre Hospitalier de Lens - Lens
- CHU Poitiers - Poitiers
- CHU Toulouse_Rangueil University Hospital - Toulouse
North Carolina
- Duke University - Durham
- East Carolina University - Greenville
Ohio
- University Hospitals Cleveland - Cleveland
- Cleveland Clinic - Cleveland
Pennsylvania
- University of Pennsylvania - Philadelphia
- Lankenau Institute for Medical Research - Wynnewood
Indiana
- St. Vincent Heart Center of Indiana - Indianapolis
Louisiana
- Ochsner Clinic Foundation - New Orleans
Maine
- Maine Medical Center - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,150 participants |
| Start Date | 2021-06-29 |
| Est. Completion | 2035-12-31 |
What NCT05002543 shows while recruiting
NCT05002543 is an observational study that tracks outcomes without assigning an intervention. Its 2,150 participants enrollment target places it among the larger protocols in the corpus.
The record links to 1 condition, with Cardiac Valve Disease appearing as the primary indexed condition, and to 0 interventions.
NCT05002543 names 20 study sites across 7 states, led by Other, North Carolina, Ohio.
Frequently Asked Questions
What is clinical trial NCT05002543 about?
NCT05002543 is a clinical study titled "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...
What is the current status of trial NCT05002543?
This trial is currently recruiting. The enrollment target is 2,150 participants. The study started on 2021-06-29. Estimated completion is 2035-12-31.
What conditions does trial NCT05002543 study?
This clinical trial studies the following conditions: Cardiac Valve Disease.
Who is sponsoring clinical trial NCT05002543?
This trial is sponsored by Corcym S.r.l, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05002543 being conducted?
This trial has 20 study locations across Indiana, Louisiana, Maine, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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