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

Sponsor: Corcym S.r.l

NCT ID: NCT05002543

View on ClinicalTrials.gov ↗

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.

Cardiac Valve Disease

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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
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)

Where Is This Study? (3 UK sites)

Queen Elisabeth Medical Centre

Birmingham B15 2TH, United Kingdom

Recruiting
Site contact (verified)

Bristol Royal Infirmary

Bristol BS2 8HW, United Kingdom

Recruiting
Site contact (verified)

King's College Hospital

London SE5 9RS, United Kingdom

Recruiting
Site contact (verified)
Max Baghaimbaghai@nhs.net

How to Get in Touch

Silvia Dipinto

Sponsor contact

CONTACT

+39 346 1284042 silvia.dipinto@corcym.com

Michela Paroli

Sponsor contact

CONTACT

+39 348 michela.paroli@corcym.com
Data sourced from ClinicalTrials.gov · Last verified: 2024-03