GIse Registry Of Transcatheter Treatment of Mitral Valve regurgitaTiOn (GIOTTO)
GIse Registry Of Transcatheter Treatment of Mitral Valve regurgitaTiOn (GIOTTO)
The current state of the art management of severe mitral regurgitation is surgical mitral
 valve repair, either with open chest surgery or mini-thoracotomy. However, standard surgical
 approaches requiring cardiopulmonary bypass are suitable for patients with low or moderate
 surgical risk, thus many patients are denied surgery because of unfavorable risk-benefit
 balance. The EuroHeart Surveyconducted by the ESC showed that one half of patients with
 severe mitral regurgitation were denied surgical treatment because they were felt to be at
 too high risk for surgery by the referring physician. Such patients are usually elderly and
 have co-morbidities. Thus, there is a need for novel devices enabling interventional
 cardiologists and cardiothoracic surgeons to perform mitral repair in a minimally-invasive
 fashion and possibly without cardiopulmonary bypass. The landmark EVEREST II trial randomized
 279 patients with grade 3/4 MR in a 2:1 fashion to MitraClip® or surgical repair/replacement
 showing a lower major adverse event rate at 30-days in the MitraClip® group (15.0% vs. 48%;
 superiority p<0.001), mainly driven by the need for blood transfusion with surgery, and the
 primary efficacy endpoint of freedom from the combined outcome of death, new surgery for
 mitral valve dysfunction or the occurrence of >2+ MR was achieved in 55% vs. 73%
 (non-inferiority p=0.007). However, this study has included a highly selected patient cohort
 in which patients with significant surgical risk have been excluded. More recently,
 Multinational (ACCESS-EU, EVEREST-High Risk) and national registries (TRAMI, SWISS) have
 shown safety and efficacy in the real world experience. Patients currently treated are high
 risk, elderly, with comorbidities and mainly affected by FMR. There is need for an Italian
 registry, since Italy has produced the second largest volume of transcathetermitral
 procedures in the world after Germany. The present registry is designed to collect real world
 clinical data on early and long-term outcomes following percutaneous mitral regurgitation
 therapy in consecutive patients undergoing transcatheter procedures in Hospitals linked to
 the GISE database.
The main objective is to achieve demographic and outcome data and identify predictors of
 clinical success, according to real-world Italian data. In addition the registry is designed
 to obtain health economic data to support reimbursement strategies in Italy. The study is
 focusing on MITRACLIP therapy since this is the leading method for treatment currently in
 Italy.

 All consecutive patients undergone/ undergoing a transcatheter mitral valve repair, with
 Mitraclip device, will be enrolled to reach a number of about 1100 patients in about 22
 hospitals. Data analysis will be conducted at the end of follow-up period of the last
 enrolled patient. . Additional data analysis will be done according to specific topics,
 approved by the scientific board of GISE and or on Ethic Committees requests. The population
 of the study is patients undergoing/undergone a transcatheter mitral valve repair procedure
 in hospitals linked to the GISE network. More specifically Patients from the investigators'
 general Mitraclip treatment patient population will be eligible to be enrolled in this
 Registry. Patients should meet all the inclusion criteria and none of the exclusion criteria.
 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.

 Follow-up visit will be performed at 30 days, 1 year and up to 5 years after the procedure.
Inclusion Criteria:

 -  Patients who are eligible for Mitraclip device according to current national and
 international guidelines (and their future revisions) and per investigator evaluation;

 -  Patients who are willing and capable of providing informed consent, participating in
 all Follow-ups associated with this clinical investigation at an approved clinical
 investigational center;

 More specifically patients inclusion criteria are in line with the indications for use
 detailed in the IFU in particular, patients have to meet the following inclusions criteria

 1. Symptomatic severe (4+) MR, or 3+ MR and NYHA > II.

 2. Mitral valve anatomy should be suitable for MitraClip.

 3. Signed (by subject or legal representative) and dated approved subject informed
 consent form prior to any study related data collection.

 Exclusion Criteria:

 -  Valve anatomy is unsuitable for MitraClip therapy as per the indication in the
 Mitraclip IFU

 -  Currently participating in the study of an investigational drug or device

 -  The subject is unable or not willing to complete follow-up visits and examination for
 the duration of the study.