GIse Registry Of Transcatheter Treatment of Mitral Valve regurgitaTiOn (GIOTTO)

NCT ID: NCT03521921

Last Updated: 2023-12-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 1500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-02-01
• Study Completion Date: 2025-09-09

Brief Summary

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.

Detailed Description

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.

Conditions

Mitral Regurgitation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Mitraclip

Edge-to edge mitral valve repair

Intervention Type: DEVICE

Eligibility Criteria

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;

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Policlinico S. Donato

OTHER

Sponsor Role: lead

Responsible Party

Francesco Bedogni

Head of Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francesco Bedogni, Dr.

Role: PRINCIPAL_INVESTIGATOR

IRCCS Policlinico S. Donato

Locations

IRCCS Policlinico San Donato

San Donato Milanese, Milan, Italy

ASST Papa Giovanni XXIII

Bergamo, , Italy

Fondazione Poliambulanza

Brescia, , Italy

Spedali Civili

Brescia, , Italy

Pineta Grande

Castel Volturno, , Italy

Ospedale Ferrarotto

Catania, , Italy

Cardiologia Università Magna Graecia

Catanzaro, , Italy

Maria Cecilia Hospital

Cotignola, , Italy

Ospdale dell'Angelo ULSS12 Veneziana

Mestre, , Italy

Centro Cardiologico Monzino

Milan, , Italy

Ospedale San Raffaele - Cardiochirurgia

Milan, , Italy

Ospedale San Raffaele - Emodinamica

Milan, , Italy

AORN Dei Colli "V. Monaldi - Cardiologia Interventistica

Napoli, , Italy

AORN dei Colli "V. Monaldi" - Emodinamica

Napoli, , Italy

UOC cardiologia Università di Padova

Padua, , Italy

Fondazione IRCCS Policlinico San Matteo

Pavia, , Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, , Italy

Azienda Ospedaliera San Camillo Forlanini

Roma, , Italy

IRCCS Humanitas

Rozzano, , Italy

AOU San Giovanni di Dio e Ruggi D'Aragona

Salerno, , Italy

Countries

Italy

Other Identifiers

GISE/01/2014/GIOTTO

Identifier Type: -

Identifier Source: org_study_id