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

NCT03521921 | Unknown DMC

• 1 other identifier: GISE/01/2014/GIOTTO
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 20

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.

Conditions

Mitral Regurgitation

Outcome Measures

Primary Outcomes (1)

• Mortality

  cardiovascular and non-cardiovascular death events with specificed cause.

  From index procedure up to 5 years

Secondary Outcomes (2)

• MACCE

  From index procedure up to 5 years

• Reduction of MR

  Within 7 days after procedure and 1 year and up to 5 years.

Interventions

Mitraclip DEVICE

Edge-to edge mitral valve repair

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any subject who already received or deemed suitable and selected by the site to receive the Mitraclip treatment, in accordance with all applicable device Instructions For Use, should be considered for entry into this study. Eligibility will be documented on the inclusion/exclusion criteria sheet. Subjects who meet the eligibility criteria and have signed and dated the Informed Consent Form and actually undergone / undergo a Mitraclip implant procedure are considered enrolled in the study.

You may qualify if:

• 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;
• Symptomatic severe (4+) MR, or 3+ MR and NYHA \> II.
• Mitral valve anatomy should be suitable for MitraClip.
• Signed (by subject or legal representative) and dated approved subject informed consent form prior to any study related data collection.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Policlinico S. Donato: lead

Study Sites (20)

IRCCS Policlinico San Donato

San Donato Milanese, Milan, 20097, Italy

Location

ASST Papa Giovanni XXIII

Bergamo, Italy

Location

Fondazione Poliambulanza

Brescia, Italy

Location

Spedali Civili

Brescia, Italy

Location

Pineta Grande

Castel Volturno, Italy

Location

Ospedale Ferrarotto

Catania, Italy

Location

Cardiologia Università Magna Graecia

Catanzaro, Italy

Location

Maria Cecilia Hospital

Cotignola, Italy

Location

Ospdale dell'Angelo ULSS12 Veneziana

Mestre, Italy

Location

Centro Cardiologico Monzino

Milan, Italy

Location

Ospedale San Raffaele - Cardiochirurgia

Milan, Italy

Location

Ospedale San Raffaele - Emodinamica

Milan, Italy

Location

AORN Dei Colli "V. Monaldi - Cardiologia Interventistica

Napoli, Italy

Location

AORN dei Colli "V. Monaldi" - Emodinamica

Napoli, Italy

Location

UOC cardiologia Università di Padova

Padua, Italy

Location

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

Location

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

Location

Azienda Ospedaliera San Camillo Forlanini

Roma, Italy

Location

IRCCS Humanitas

Rozzano, Italy

Location

AOU San Giovanni di Dio e Ruggi D'Aragona

Salerno, Italy

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Francesco Bedogni, Dr.

  IRCCS Policlinico S. Donato

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Cardiology

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: May 11, 2018
• Study Start: February 1, 2016
• Primary Completion: February 1, 2021
• Study Completion: September 9, 2025
• Last Updated: December 5, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (20)