Actively Recruiting
First-In-Human Clinical Study for Treatment of Severe Mitral Valve INsufficiency With Epygon™ TRanscatheter Mitral VAlve System
Led by Epygon · Updated on 2023-08-07
40
Participants Needed
10
Research Sites
465 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The EPYGON VALVE is an innovative mitral valve, intended for valve replacement of a native mitral valve through a minimally invasive implant procedure by means of a dedicated implant device. The EPYGON VALVE is a bio prosthesis, composed by a functional assembly of bovine pericardium on a NiTinol stent. The purpose of this trial is to assess the safety and feasibility of the Epygon™ Transcatheter mitral valve and the transapical delivery system, in adult patients with severe, symptomatic mitral regurgitation.
CONDITIONS
Official 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...
- Patients aged 60 years or older
- Patients with primary or secondary severe symptomatic mitral valve regurgitation
- Patients evaluated by a multidisciplinary Heart Team and deemed ineligible for conventional valve surgery and transcatheter repair
- Patients with left ventricular ejection fraction of 30% or higher
- Patients in New York Heart Association functional classes III to IV
- Patients who have signed informed consent and accepted participation
- Patients willing to comply with all protocol requirements
- Patients not planning to transfer abroad
You will not qualify if you...
- Patients participating in other clinical studies that may affect study outcomes
- Patients with clinical or anatomical conditions unsuitable for transapical surgical approach
- Patients with previous transcatheter aortic valve prosthesis implantation
- Patients with previous mitral heart valve prosthesis implantation
- Patients with previous mitral annuloplasty ring implantation
- Patients requiring emergency or life-saving interventions
- Patients with heavily calcified mitral annulus or anterior mitral leaflet
- Patients with active or suspected infection or endocarditis
- Patients with intracardiac mass or thrombus seen on echocardiography
- Patients with acute myocardial infarction within 30 days before treatment
- Patients with active peptic ulcer or upper gastrointestinal bleeding within 30 days
- Patients allergic to contrast media or any device components
- Patients with neurological diseases severely affecting walking or daily function
- Patients with stroke within 30 days
- Patients with senile dementia diagnosed by a neurologist
- Patients unable to undergo or contraindicated for transesophageal echocardiography
- Patients unwilling or unable to comply with study protocol
- Patients unable to understand or sign informed consent without legal representative
- Patients lacking capacity to consent
- Patients unable to read and write
- Patients with left ventricular apex aneurysm
- Patients with aorto-mitral angle less than 120 degrees
- Patients with mitral valve area incompatible with device sizing matrix
- Patients with ventricular morphology unsuitable for the device design
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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