Actively Recruiting
First-In-Human Clinical Study for Treatment of Severe Mitral Valve Insufficiency With Epygon Transcatheter Mitral Valve System (MINERVA FIH)
Led by Epygon · Updated on 2023-08-07
40
Participants Needed
10
Research Sites
269 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and feasibility of the Epygon Transcatheter mitral valve system in adults aged 60 and older who have severe and symptomatic mitral valve regurgitation. This innovative bio prosthetic valve is made from bovine pericardium mounted on a NiTinol stent and is designed for minimally invasive replacement of the native mitral valve. The study aims to provide an alternative for patients who are not eligible for conventional valve surgery or transcatheter repair. The trial involves implanting the Epygon mitral valve prosthesis using a transapical delivery system. This minimally invasive procedure replaces the damaged mitral valve through a dedicated device. Participants will receive this implant and be monitored to assess the device's safety and success shortly after implantation and over time. Participants will undergo various assessments including echocardiography to evaluate heart function, six-minute walk tests, and quality of life questionnaires before and after implantation. Follow-up visits occur at 30 days, 3, 6, 12 months, and yearly up to 5 years to monitor device safety, clinical status, hemodynamic performance, and adverse events. The study tracks multiple outcomes such as procedural success, device safety, and patient functional improvement throughout this period.
CONDITIONS
Brief Title
First-In-Human Clinical Study for Treatment of Severe Mitral Valve INsufficiency With Epygon™ TRanscatheter Mitral VAlve System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 60 years or older
- Primary or secondary severe symptomatic mitral valve regurgitation
- Deemed ineligible for conventional valve surgery and not eligible for transcatheter repair by a Heart Team
- Left ventricular ejection fraction of 30% or higher
- NYHA functional class III or IV
- Provided informed consent to participate
- Willing to follow all study procedures
- Not planning to move abroad during the study
You will not qualify if you...
- Participating in other clinical studies affecting this trial's results
- Unsuitable for transapical surgical approach
- Previous transcatheter aortic valve prosthesis implantation
- Previous mitral valve prosthesis implantation
- Previous mitral annuloplasty ring implantation
- Need for emergency or life-saving interventions
- Heavily calcified mitral annulus or anterior mitral leaflet
- Active infection or endocarditis
- Intracardiac mass or thrombus seen on echocardiography
- Acute myocardial infarction within 30 days before treatment
- Active peptic ulcer or upper gastrointestinal bleeding within 30 days
- Allergy to contrast media or device components
- Neurological diseases severely affecting movement or daily function
- Stroke within the prior 30 days
- Senile dementia diagnosed by neurologist
- Contraindication for transesophageal echocardiography
- Unwillingness or inability to comply with study requirements
- Unable to understand or sign informed consent without legal representative
- Lack of capacity to consent
- Unable to read and write
- Left ventricular apex aneurysm
- Aorto-mitral angle less than 120 degrees
- Mitral valve area incompatible with device sizing policy
- Ventricular morphology unsuitable for valve design as per CT scan
- Any other conditions making patient unsuitable for study valve implantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of procedure
Participants undergo implantation of the Epygon™ Transcatheter Mitral Valve System through a minimally invasive procedure to replace the native mitral valve.
1 implantation visit (in-person)
Duration - Up to 30 days after implantation
Participants receive immediate care following the valve implantation procedure to monitor device safety and procedural success.
Multiple visits within 30 days (in-person)
Duration - Up to 5 years after implantation
Participants attend follow-up visits to assess device safety, clinical status, quality of life, and valve performance over time.
Visits at 3, 6, 12 months and yearly up to 5 years (in-person)
Trial Site Locations
Total: 10 locations
1
Medical University of Innsbruck
Innsbruck, Austria
Actively Recruiting
2
Medical University of Vienna - Department of Surgery, Division of Cardiac Surgery
Vienna, Austria
Actively Recruiting
3
Careggi Hospital Florence Italy Largo Brambilla
Florence, Italy
Actively Recruiting
4
A.O.U. Citta della Salute e della Scienza di Torino
Torino, Italy
Actively Recruiting
5
Dedinje Cardiovascular Institute
Belgrade, Serbia
Not Yet Recruiting
6
Hospital German Trias i Pujol
Badalona, Spain
Actively Recruiting
7
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Actively Recruiting
8
Hospital Clinico San Carlos
Madrid, Spain
Actively Recruiting
9
Hospital Virgen de la Arrixaca
Murcia, Spain
Actively Recruiting
10
Hospital Universitario Virgen Del Rocio
Seville, Spain
Not Yet Recruiting
Research Team
C
Christophe Giot
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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