An observational study in Mitral Regurgitation, sponsored by IRCCS Policlinico S. Donato. Active, not recruiting at 20 sites in Italy. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-12-05.
Sponsored by IRCCS Policlinico S. Donato · Observational
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.
459 studies on the registry are indexed under Mitral Valve Insufficiency; 148 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 154 across 167 observational studies indexed under Mitral Valve Insufficiency.
Browse Mitral Valve Insufficiency studies →IRCCS Policlinico S. Donato is the lead sponsor of 101 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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
Exclusion Criteria:
Edge-to edge mitral valve repair
Mortality
cardiovascular and non-cardiovascular death events with specificed cause.
Time frame: From index procedure up to 5 years
MACCE
cardiovascular and cerebrovascular major adverse events.
Time frame: From index procedure up to 5 years
Reduction of MR
Reduction of MR evaluated with a scale 1 to 4
Time frame: Within 7 days after procedure and 1 year and up to 5 years.
Plan to share: No — The data will be reviewed by a Data Safety and Monitoring Board. The Data Safety and Monitoring Board will be also responsible for: * Determining whether information collected are sufficient to address the objectives * Recommending modifications to the statistical analysis plan to address additional research questions based on review of the data
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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IRCCS Policlinico S. Donato