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Recruiting NCT05455489

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

— Observational Mitral Valve Regurgitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Mitral Valve Regurgitation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The GIOTTO4 Study: GISE Registry of Transcatheter Treatment of Mitral Valve Regurgitation With the MitraClip G4

Overview

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.

Primary outcome measures

  • percentage of participants with a mitral regurgitation (MR) [Time frame: at 30 days]
  • percentage of participants with a mitral regurgitation (MR) [Time frame: at 1 year]
Secondary outcome measures (6)
  • composite of all-cause death and hospitalization for heart failure (HF), [Time frame: at 30 days]
  • composite of all-cause death and hospitalization for heart failure (HF), [Time frame: at 1 year]
  • composite of all-cause death and hospitalization for heart failure (HF), [Time frame: at 2 years]
  • composite of all-cause death and hospitalization for heart failure (HF), [Time frame: at 3 years]
  • composite of all-cause death and hospitalization for heart failure (HF), [Time frame: at 4 years]
  • composite of all-cause death and hospitalization for heart failure (HF), [Time frame: at 5 years]

Eligibility criteria

Inclusion criteria

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)

Exclusion criteria

  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • I.R.C.C.S. Policlinico San Donato — San Donato Milanese

Identifiers

NCT: NCT05455489 · GISE_GIOTTO4

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗