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

Mitral Regurgitation Clinical Trial

— GIOTTO  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03521921
• Other study ID #: GISE/01/2014/GIOTTO
• Status: Active, not recruiting
• Start date: February 1, 2016
• Est. completion date: September 9, 2025

Study information

• Verified date: December 2023
• Source: IRCCS Policlinico S. Donato
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1500
• Est. completion date: September 9, 2025
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

Device:
• Mitraclip
Edge-to edge mitral valve repair

Locations

Country	Name	City	State
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	Milano
Italy	Ospedale San Raffaele - Cardiochirurgia	Milano
Italy	Ospedale San Raffaele - Emodinamica	Milano
Italy	AORN Dei Colli "V. Monaldi - Cardiologia Interventistica	Napoli
Italy	AORN dei Colli "V. Monaldi" - Emodinamica	Napoli
Italy	UOC cardiologia Università di Padova	Padova
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	IRCCS Policlinico San Donato	San Donato Milanese	Milan

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Donato

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	cardiovascular and non-cardiovascular death events with specificed cause.	From index procedure up to 5 years
Secondary	MACCE	cardiovascular and cerebrovascular major adverse events.	From index procedure up to 5 years
Secondary	Reduction of MR	Reduction of MR evaluated with a scale 1 to 4	Within 7 days after procedure and 1 year and up to 5 years.