Actively Recruiting
GISE Registry of Transcatheter Treatment of Mitral Valve Regurgitation With the MitraClip G4
Led by Fondazione GISE Onlus · Updated on 2024-03-04
264
Participants Needed
1
Research Sites
340 weeks
Total Duration
On this page
Sponsors
F
Fondazione GISE Onlus
Lead Sponsor
U
University of Padova
Collaborating Sponsor
AI-Summary
What this Trial Is About
The aim of the GISE study is to confirm the MitraClip safety and improve the device effectiveness in a selected all comers ("more-comers") population with symptomatic severe mitral regurgitation undergoing/undergone Transcatheter Edge-to-Edge Repair (TEER) with MitraClip G4.
CONDITIONS
Official Title
GISE Registry of Transcatheter Treatment of Mitral Valve Regurgitation With the MitraClip G4
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Patients with symptomatic severe secondary (functional) mitral regurgitation (MR) of grade 3-4+, ischemic or non-ischemic
- Left ventricular end-systolic dimension less than 70 mm
- Mitral valve area greater than 4 cm2
- Left ventricular ejection fraction of 20% or higher
- NYHA functional class II, III, or ambulatory IV
- Brain natriuretic peptide (BNP) level 300 pg/ml or higher or NT-proBNP 1500 pg/ml or higher and/or at least one hospitalization for heart failure in the past 12 months
- Patients adequately treated according to standards including for coronary artery disease, left ventricular dysfunction, mitral regurgitation, and heart failure
- Local Heart-team decision
- Patients with symptomatic severe primary (degenerative) mitral regurgitation (MR) of grade 3-4+
- Mobile mitral valve length of posterior leaflet 8 mm or more (NT device) or 10 mm or more (XT device)
- NYHA functional class greater than II
- Local Heart-team decision
You will not qualify if you...
- Significant right ventricular dysfunction (TAPSE less than 15 mm and/or S' less than 8 cm/s)
- Systolic pulmonary artery pressure greater than 70 mmHg with irreversible precapillary pulmonary hypertension
- Severe tricuspid valve regurgitation
- Hemodynamic instability or NYHA class IV heart failure
- Impaired mobility due to neurological or musculoskeletal disease or advanced dementia
- Leaflet anatomy unsuitable for MitraClip implantation or proper positioning
- Hypertrophic, restrictive, constrictive, or infiltrative cardiomyopathies
- Coronary artery bypass graft, percutaneous coronary intervention, transcatheter aortic valve replacement, or cardiovascular accident within the prior 60 days
- Life expectancy less than 12 months due to non-cardiac causes
- Active infections
- Advanced heart failure or bridge to heart transplant/left ventricular assist device
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
I.R.C.C.S. Policlinico San Donato
San Donato Milanese, Milano, Italy, 20097
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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