At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Not specified by the sponsor
- How long the study runs
- Study runs about 174 months (dates as stated)
- About the drug or intervention
- Not specified by the sponsor
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, run by Corcym S.r.l., looks at people with cardiac valve disease (problems with heart valves) who are treated with Corcym heart valve products in everyday real-world care. It is a post-market study, meaning it collects information after the products are already in normal use.
Who can take part
- You (or a parent/guardian) have signed an informed consent form agreeing to take part
- You are willing and able to follow the study's follow-up schedule
- You can be treated with Corcym aortic, mitral and/or tricuspid valve products, as set out in the product instructions
Who may not be able to
- You are already taking part in another clinical study that could affect this study's results
- You have a life expectancy of 12 months or less
- You have any reason why Corcym aortic, mitral or tricuspid devices should not be used, as set out in the product instructions
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Observing health over time
- Ages
- Not specified
- Who
- All
- Number of participants
- 2,150
- Started
- 2021-06-29
- Last checked
- 2024-03
Plain English Summary
What is this study?
- • Testing a new treatment for cardiac valve disease
- • Clinical study - 2,150 participants
- • MANTRA is a prospective, multiple-arm, multi-center, global, post-market clinical follow-up study
Who can take part?
- • Adults
- • Diagnosed with cardiac valve disease
Where?
- • Birmingham - Queen Elisabeth Medical Centre
- • Bristol - Bristol Royal Infirmary
- • London - King's College Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: Not specified
- Who can join: All genders
What the study is looking for
- ✓Signed and dated approved agreement to take part
- ✓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...
Who cannot take part
- ✗Subject is already participating to another clinical investigation that could confound the results of this clinical...
- ✗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...
See the full criteria
Where Is This Study? (3 UK sites)
Queen Elisabeth Medical Centre
Birmingham B15 2TH, United Kingdom
Bristol Royal Infirmary
Bristol BS2 8HW, United Kingdom
King's College Hospital
London SE5 9RS, United Kingdom
How to Get in Touch
Silvia Dipinto
Sponsor contactCONTACT
Michela Paroli
Sponsor contactCONTACT
