NCT05002543 (MANTRA) is a clinical trial in Cardiac Valve Disease, sponsored by Corcym S.r.l.

Who is sponsoring NCT05002543?

NCT05002543 is sponsored by Corcym S.r.l.

What condition does NCT05002543 study?

NCT05002543 studies Cardiac Valve Disease.

Is NCT05002543 still recruiting?

NCT05002543 is currently recruiting now. Last updated 6 March 2024.

Last reviewed 2024-03-06 · How we verify

NCT05002543: MANTRA

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

CORCYM Mitral, Aortic aNd Tricuspid Post-maRket Study in a reAl-world Setting

Recruiting now Last updated 6 March 2024

What this trial tests

trial in Cardiac Valve Disease in 2,150 participants. Currently enrolling.

Timeline

29 June 2021

Primary endpoint
30 August 2025

31 December 2035

Quick facts

Lead sponsor	Corcym S.r.l
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	2,150
Start date	29 June 2021
Primary completion	30 August 2025
Estimated completion	31 December 2035
Sites	52 locations across France, Italy, Netherlands, Belgium, Austria, Serbia, United Kingdom, Germany

Conditions studied

Cardiac Valve Disease — all drugs for Cardiac Valve Disease →

Sponsor

Corcym S.r.l

Who can join

Eligibility, any sex, with Cardiac Valve Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Early outcomes of aortic valve replacement with Perceval PLUS sutureless valve: results of the prospective multicentric MANTRA study.
Micovic S, Nobre A, Choi JW, Solinas M, et al · · 2024 · cited 7× · PMID 38902742 · DOI 10.1186/s13019-024-02861-1
The MANTRA study: a new umbrella concept prospectively applied to assess implantable medical devices for heart valve procedures.
Meuris B, Günaydın S, Lancellotti P, Badano L, et al · · 2023 · cited 4× · PMID 37029428 · DOI 10.1186/s13019-023-02270-w
A chronological history of heart valve prostheses to offer perspectives of their limitations.
Evangelista RAA, Pires ALR, Nogueira BV. · · 2025 · cited 1× · PMID 40028289 · DOI 10.3389/fbioe.2025.1533421
Mitral valve repair with the semi-rigid Memo 4D annuloplasty ring: early clinical and echocardiographic outcomes from the MANTRA study.
Dzemali O, Rodriguez Cetina Biefer H, Di Eusanio M, Fabre O, et al · · 2024 · PMID 39666948 · DOI 10.1093/icvts/ivae208

Verify or expand the search:

Other recruiting trials for Cardiac Valve Disease

Currently open trials in the same condition.

NCT06247358 — Frailty, Physical Capacity and Lung Function in Postoperative Cardiac Surgery Patients · recruiting
NCT06336213 — Antibacterial Tactics Based on Presepsin Level in Thoracic Aorta Surgery Patients · NA · recruiting
NCT05506293 — European Multicentre Registry of Percutaneous Paravalvular Leak Closure · recruiting

Other Corcym S.r.l trials

Trials by the same sponsor.

NCT03481387 — PERCEVAL S Valve Clinical Study for Chinese Registration · NA · unknown
NCT03200574 — Behavior of Valve Leaflets Following Aortic Valve Implant · NA · completed
NCT02673697 — Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement · NA · terminated
NCT01368666 — Safety and Effectiveness Study of Perceval S Valve for Extended CE Mark · NA · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05002543 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Corcym S.r.l
Last refreshed: 6 March 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05002543.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing