Actively Recruiting
The GIOTTO4 Study: 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
N/A
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 trial focuses on patients with symptomatic severe mitral regurgitation (MR), either functional or degenerative, who have undergone or are undergoing Transcatheter Edge-to-Edge Repair (TEER) using the MitraClip G4 device. The aim is to confirm the safety of the MitraClip and improve its effectiveness in a broad group of patients with severe MR. This observational study involves participants with both ischemic and non-ischemic causes of MR on optimal medical therapy. Participants are divided into two groups based on their MR type: functional MR with severe secondary MR and degenerative MR with severe primary MR. Eligibility for each group is determined using a multiparametric study algorithm assessing MR severity and other heart function measures. The study tracks the outcomes after the MitraClip procedure, focusing on MR severity and clinical events over several years. Throughout the study, participants will be monitored for MR severity at 30 days and one year, alongside longer-term outcomes such as death and hospitalizations for heart failure over up to five years. Data will be collected to evaluate device safety and effectiveness in real-world settings. Participants will undergo heart function evaluations and follow-ups as part of the registry to assess the impact of the MitraClip treatment.
CONDITIONS
Brief Title
GISE Registry of Transcatheter Treatment of Mitral Valve Regurgitation With the MitraClip G4
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Patients with symptomatic severe secondary mitral regurgitation (3-4+) of ischemic or non-ischemic origin on optimal medical therapy
- Left ventricular end-systolic dimension less than 70 mm
- Mitral valve area greater than 4 cm2
- Left ventricular ejection fraction 20% or higher
- NYHA functional class II, III, or ambulatory IV
- Brain natriuretic peptide (BNP) 300 pg/ml or higher or NT-proBNP 1500 pg/ml or higher, or at least one hospitalization for heart failure in the past 12 months
- Patients with symptomatic severe primary mitral regurgitation (3-4+)
- Mobile mitral valve length of posterior leaflet 8 mm or more for NT device, 10 mm or more for XT device
- NYHA functional class higher than II
- Adequate treatment as determined by 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 over 70 mmHg with irreversible precapillary pulmonary hypertension
- Severe tricuspid valve regurgitation
- Hemodynamic instability or NYHA class IV
- Impaired mobility due to neurological, musculoskeletal disease, or advanced dementia
- Leaflet anatomy unsuitable for MitraClip implantation or positioning
- Hypertrophic, restrictive, constrictive, or infiltrative cardiomyopathies
- Recent coronary artery bypass graft, percutaneous coronary intervention, transcatheter aortic valve replacement, or cardiovascular accident within the last 60 days
- Life expectancy less than 12 months due to non-cardiac conditions
- Active infections
- Advanced heart failure or bridging to heart transplant or left ventricular assist device
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 - Up to 5 years
Participants who undergo routine care for mitral valve regurgitation are observed to collect data on their condition and outcomes.
Follow-up visits at 30 days, 1 year, and annually up to 5 years
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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