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

Conditions

• Cardiac Valve Disease

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Study Details

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

Key Dates

Start date

Jun 29, 2021

Status verified

Mar 2024

Primary completion

Aug 30, 2025

Completion

Dec 31, 2035

Study Design

Enrollment

2,150 participants (estimated)

Arms

• Arm: MANTRA Aortic Sub-study
  Subjects diagnosed with aortic valve disease who are considered suitable to undergo aortic valve replacement with a CORCYM device can be included in this study. The following devices can be entered in the study: Tissue Valve: * Perceval® PLUS SUTURELESS AORTIC HEART VALVE * Perceval® S SUTURELESS AORTIC HEART VALVE Mechanical Valves: * Bicarbon™ Bileaflet Heart Valve Prostheses Models: * Bicarbon Fitline Aortic (LFA) * Bicarbon Slimline Aortic (LSA) * Bicarbon Overline Aortic (LOV) * Carbomedics Prosthetic Heart Valve Models: * Standard Aortic Valve * Reduced Aortic Valve * Supra-Annular Aortic Valve (Top Hat) * Orbis™ Aortic Valve Ascending Aorta Prostheses * CARBOMEDICS-CARBO-SEAL™ * CARBOMEDICS CARBO-SEAL™ VALSALVA
• Arm: MANTRA Mitral/Tricuspid Sub-study
  Subjects diagnosed with mitral and/or tricuspid valve disease who are considered suitable to undergo mitral valve repair/replacement and/or tricuspid valve repair with a CORCYM device can be included in this study. The following devices can be entered in the study: Annuloplasty Rings: * SOVERING™ ANNULOPLASTY DEVICE models * annuloplasty ring, mitral model * annuloplasty band, mitral and tricuspid models * Carbomedics Annuloplasty Ring models: * CARBOMEDICS ANNULOFLO® * CARBOMEDICS ANNULOFLEX® * Memo Annuloplasty Ring o MEMO 3D™ SEMIRIGID ANNULOPLASTY RING Mitral Valves: * Bicarbon™ Bileaflet Heart Valve Prostheses Models: o Bicarbon Fitline Mitral (LFM) * Carbomedics Prosthetic Heart Valve Models: * Standard Mitral Valve * Orbis™ Mitral Valve * OptiForm® Mitral Valve
• Arm: MANTRA Memo 4D Sub-study
  Subjects diagnosed with mitral valve disease who are considered suitable to undergo mitral valve repair with a CORCYM Memo 4D annuloplasty ring can be included in this study.

Primary Outcome Measure

The primary endpoint in the AORTIC Sub-study is number and percentage of subjects with Device Success [ Time Frame: 30 days ]

Central Contacts

• Silvia Dipinto
  +39 346 1284042
  [email protected]
• Michela Paroli
  +39 348
  [email protected]

Locations (9)

Find similar trials in Indianapolis, IN