GISE Registry of Transcatheter Treatment of Mitral Valve Regurgitation With the MitraClip G4

NCT05455489 | Recruiting DMC

• 1 other identifier: GISE_GIOTTO4
• Study Type: observational
• Target: 264
• Locations: 1 country
• Sites: 1

Brief Summary

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

Mitral Valve Regurgitation

Outcome Measures

Primary Outcomes (2)

• percentage of participants with a mitral regurgitation (MR)

  grade ≤1+. Two separates subgroups will be identified according to the presence of functional (FMR) or degenerative (DMR) mitral valve disease.

  at 30 days

• percentage of participants with a mitral regurgitation (MR)

  grade ≤1+. Two separates subgroups will be identified according to the presence of functional (FMR) or degenerative (DMR) mitral valve disease.

  at 1 year

Secondary Outcomes (6)

• composite of all-cause death and hospitalization for heart failure (HF),

  at 30 days

• composite of all-cause death and hospitalization for heart failure (HF),

  at 1 year

• composite of all-cause death and hospitalization for heart failure (HF),

  at 2 years

• composite of all-cause death and hospitalization for heart failure (HF),

  at 3 years

• composite of all-cause death and hospitalization for heart failure (HF),

  at 4 years

Study Arms (2)

FUNCTIONAL MR

Patients with symptomatic severe secondary MR (3-4+, according to the multiparametric study algorithm), both ischemic or non-ischemic etiology, on optimal medical therapy

DEGENERATIVE MR

Patients with symptomatic severe primary MR (3-4+, according to the multiparametric study algorithm)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing/undergone to TEER procedure with MitraClip G4 in selected hospitals linked to the GISE network. Patients should meet all the inclusion criteria and none of the exclusion criteria; such criteria will identify a selected all comers ("more-comers") population which includes the vast majority of patients treated with MitraClip in daily practice. Retrospective enrolments are allowed if available data are in line with the study requirements and the patients can give their consent to be enrolled in the study informed consent process. Patients who don't meet one or more of the inclusion criteria or met at least one exclusion criteria are excluded from the study; however, a selected list of baseline/procedural features and follow-up data will be recorded for excluded patients.

You may qualify if:

• SUBGROUP A: FUNCTIONAL MR Patients with symptomatic severe secondary MR (3-4+, according to the multiparametric study algorithm), both ischemic or non-ischemic etiology, on optimal medical therapy AND
• Left Ventricular End-Systolic Dimension \<70 mm
• Mitral Valve area \> 4 cmq
• Left ventricular ejection fraction ≥20%
• NYHA functional class II, III, ambulatory IV
• brain natriuretic peptide BNP ≥300 pg/ml or N-terminal prohormone of brain natriuretic peptide NT-proBNP ≥1500 pg/ml and/or at least one hosp for HF (Heart failure) in the 12 months prior to enrollment
• Age 18 years or older
• Subject has been adequately treated per applicable standards, including for coronary artery disease, LV (left ventricular) dysfunction, MR Mitral (regurgitation) and HF
• Local Heart-team decision SUBGROUP B: DEGENERATIVE MR Patients with symptomatic severe primary MR (3-4+, according to the multiparametric study algorithm) AND
• Mobile mitral valve (MV) length of PL ≥8 mm in case of NT device, ≥10 mm in case of XT device
• MV area \> 4 cm2
• NYHA functional class \> II
• Age 18 years or older
• Local HT decision In case of patients with a coexistence of both etiologies, they will be assigned to a subgroup based on the prevailing mechanism.
• THE MULTIPARAMETRIC ALGORITHM FOR MR GRADING The multiparametric algorithm, adapted from the criteria recommended by the American Society of Echocardiography 2003 Guidelines and based on 3 tiers of evaluation, will be used for qualification purposes to determine if MR was 3+ or higher. The 3 tiers of evaluation are applied in a hierarchical manner (from tier 1 to 3) and patients qualified for TEER by meeting the criteria of at least one of them. For MR grading purposes, MR severity was subsequently graded as 3+ or 4+ based on the integrative evaluation of multiple parameters recommended by the The American Society of Echocardiography (ASE)

You may not qualify if:

• Significant right ventricular disfunction (TAPSE\<15 mm and/or S'\<8cm/s)
• Systolic pulmonary artery \> 70 mmHg with irreversible precapillary pulmonary hypertension
• Severe TR Tricuspid valve regurgitation
• Hemodynamic instability/NYHA IV
• Impaired mobility as a result of neurological or musculoskeletal disease, or advanced dementia
• Leaflet anatomy which may preclude MitraClip implantation, proper MitraClip positioning on the leaflets or sufficient reduction in MR by the MitraClip
• Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, infiltrative cardiomyopathies
• CABG coronary artery bypass graft, PCI percutaneous coronary intervention, TAVR transcatheter aortic valve replacement, CVA cardiovascular accident within the prior 60 days
• Life expectancy \<12 months due to non-cardiac conditions
• Active infections
• Advanced HF (ESC/HFA Heart Failure Association Criteria) or Bridge tp to HTx/LVAD (left ventricular assist device)

Sponsors & Collaborators

• Fondazione GISE Onlus: lead
• University of Padova: collaborator
• Abbott: collaborator

Study Sites (1)

I.R.C.C.S. Policlinico San Donato

San Donato Milanese, Milano, 20097, Italy

RECRUITING

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2022
• First Posted: July 13, 2022
• Study Start: January 25, 2023
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: March 4, 2024

Record last verified: 2024-03

Locations

IT (1)