Monitor ongoing safety and performance of the CORCYM heart valve devices and accessories for aortic, mitral and tricuspid valvular diseases in a real-world setting.
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety and performance assessments during the study, up to 10 years after
implantation.
Endpoints are defined in detail in the sub-study specific protocols.
Secondary outcome
Statistical strategy, calculation sample handling, data analysis, and reporting
methods are described in each sub-study protocol by study-specific design,
objective, and planned endpoints of the study.
Background summary
The sponsor of this clinical trial has a full portfolio, including mechanical
and biological, heart valves for mitral and/or aortic valve replacement and
bands/rings for mitral or tricuspid valve repair, which provide the surgeon
with a variety of treatment options that can be chosen based on the anatomy and
pathophysiology of the individual patient. All products have received CE
marking or other local approval and are commercially available.
Study objective
Monitor ongoing safety and performance of the CORCYM heart valve devices and
accessories for aortic, mitral and tricuspid valvular diseases in a real-world
setting.
Study design
Patients may participate in this clinical trial if one (or more) of the heart
valves (aortic, mitral, or tricuspid) is not working properly.
The physician will review whether heart valve surgery is required. This surgery
is performed to repair the existing valve to restore valve function or to
replace a damaged valve with a biological or mechanical prosthesis. Heart valve
replacement is usually considered an appropriate option only when repair is not
possible. As the clinical trial collects information about the disease and
standard treatment, data are collected on health status before and after
treatment.
Umbrella Study Concept = adaptive study design:
One trial infrastructure (=Master)
Evaluation of multiple investigational therapies or therapeutics areas
Master protocol to contain endpoints applicable across the treatment groups
Several substudies can be added as needed
Study burden and risks
The participation in this study will last approximately 5 and up to 10 years
for the participants. During this period, the physician-investigator will
collect information related to the patient's vital signs, the evolution of the
clinical condition, any blood thinning medication, and the results of the
prescribed tests, in accordance with the standard of care:
-Blood test
-ECG results (An electrocardiogram or ECG is a recording of the electrical
activity of the heart. An ECG is a simple, non-invasive procedure. Electrodes
are placed on the skin of the chest and connected in a specific order to a
machine that, when turned on, measures electrical activity across the heart)
-Echocardiography (A diagnostic test that uses high-frequency sound waves to
create images of the heart chambers, valves and surrounding structures)
-Questionnaires quality of Life
Via Crescentino sn /
Saluggia 13040
IT
Via Crescentino sn /
Saluggia 13040
IT
Listed location countries
Age
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/tricuspid products as
outlined in the applicable IFUs
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)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05002543 |
| CCMO | NL78973.042.21 |