CORCYM Mitral, Aortic aNd Tricuspid Post-maRket Study in a reAl-world Setting
Public ClinicalTrials.gov record NCT05002543. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT05002543
- Recruitment status
- Recruiting
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 2,150 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 28, 2021
- Primary completion
- Aug 29, 2025
- Completion
- Dec 30, 2035
- Last update posted
- Mar 5, 2024
2021 – 2035
United States locations
- U.S. sites
- 9
- U.S. states
- 6
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| St. Vincent Heart Center of Indiana | Indianapolis | Indiana | 46290 | Recruiting |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | Recruiting |
| Maine Medical Center | Portland | Maine | 04102 | Withdrawn |
| Duke University | Durham | North Carolina | 27710 | Recruiting |
| East Carolina University | Greenville | North Carolina | 27858 | Recruiting |
| University Hospitals Cleveland | Cleveland | Ohio | 44106 | Recruiting |
| Cleveland Clinic | Cleveland | Ohio | 44195 | Recruiting |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | Recruiting |
| Lankenau Institute for Medical Research | Wynnewood | Pennsylvania | 19096 | Active, not recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 43 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05002543, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 5, 2024 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05002543 live on ClinicalTrials.gov.