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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione GISE Onlus

About this trial

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.

Eligibility criteria

Qualifiers

Left Ventricular End-Systolic Dimension <70 mm

Mitral Valve area > 4 cmq

Left ventricular ejection fraction ≥20%

NYHA functional class II, III, ambulatory IV

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

264 Participants
are grouped into 2 trial groups

Sponsors and collaborators

Fondazione GISE Onlus

Lead sponsor

University of Padova

Collaborator

Abbott

Collaborator