Overview
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
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 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.
Currently, three substudies are planned:
- MANTRA - Aortic Sub-Study
- MANTRA - Mitral/Tricuspid Sub-Study (excluding Memo 4D)
- MANTRA - Memo 4D Sub-Study
The aim of the studies assembled under the master protocol is the continued collection of safety and performance data during heart valve procedures and the relevant follow-up visits in subjects where any of the CORCYM devices and accessories are used in a real-world setting, in accordance with the IFUs, and at the discretion of the investigator.
MANTRA study is expected to enroll approximately 2150 subjects in up to 130 sites worldwide:
- Approximately 1650 subjects considered suitable for treatment with a CORCYM aortic device
- Approximately 300 subjects considered suitable for treatment with a CORCYM mitral and/or tricuspid device (excluding Memo 4D)
- Approximately 200 subjects considered suitable for treatment with Memo 4D
Expected enrollment duration may vary across the different projects. Subject follow-up is planned at discharge, 30 days after implantation and then annually up to 10 years. Sites can choose to participate in one or more sub-studies.
All available data shall be gathered during standard medical care.
At a minimum, the following data will be collected:
- Informed Consent
- Screening/Baseline data, including demographics and medical history
- Procedural data
- Hospitalization and Discharge data
- Follow-up data: 30 days and annually up to 10 years post procedure
- Serious Adverse Event and Device Deficiencies information
As part of the study, the subject will be asked to complete quality of life questionnaire(s) at baseline, 30 days and at 1-year follow-up.
In addition, for the MEMO 4D sub-study only, an Echocardiography Core Laboratory has been appointed by the Sponsor to assess the hemodynamic and structural performance, annular motion and dynamics, and 3D echocardiogram images (transesophageal during the procedure and transthoracic during follow up) will be collected for Corelab readings.
Eligibility
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)
