RecruitingNCT05455489

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

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


Sponsor

Fondazione GISE Onlus

Enrollment

264 participants

Start Date

Jan 25, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Italian registry study follows adults with symptomatic severe mitral regurgitation — a heart valve condition where the mitral valve leaks blood backward — who undergo a transcatheter procedure called MitraClip to repair the valve without open-heart surgery. The study collects real-world data on outcomes and safety in a broad population of patients who may not have qualified for earlier, more restrictive clinical trials. Adults aged 18 or older with severe mitral regurgitation (either structural or functional) who are not candidates for or who decline open surgery, and are in NYHA functional class II, III, or ambulatory IV, may be eligible. Participation involves the standard MitraClip procedure and follow-up visits to track heart function and quality of life. This summary was generated by AI to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

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

San Donato Milanese, Milano, Italy

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NCT05455489


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