Original Title: Sistema de reparación percutáneo de la válvula mitral mediante Clip. Estudio de monitorización (2.ª parte)

Authors' objectives: 1. Describe the profile of the patient that is implanted with a percutaneous repair of the mitral closure using a clip within the framework of the common service portfolio of the Spanish National Health Service. 2. Assess the safety of this device after the learning curve at the implant centres within the Spanish National Health Service has been overcome. 3. Assess the mid and long term effectiveness of the device in terms of survival and quality of life within the framework of the Spanish National Health Service. 4. Assess the cost-effectiveness of the implant of the device based on results obtained within the framework of the common service portfolio of the Spanish National Health Service.

Authors' results and conclusions: There is currently no monitoring study in Spain that permits more to be known about the profile of patients who are implanted with a Mitral Clip, while the results and consequences of this process on the patient’s health, as well as the impact on the Spanish National Health System are also unknown. This study has been designed as a record, the analysis of which shall enable the mid and long term efficacy and cost-effectiveness to be assessed by means of a cohort of 140 patients and an initially planned duration of 38 months.

Authors' methods: A prospective observational study without control group has been designed that is national multi-centred, which means that there is a record that includes those centres whose operators have passed the learning curve to implant a device for percutaneous mitral closure using a clip autonomously in Spain. A form has also been designed that contains the main clinical variables that enable mid and long term cost-effectiveness and safety to be adequately assessed, using scientific evidence available up to the date of design of this protocol. The variables shall be analysed every month by the evaluating Agency/Service (in this case the Basque Office for Health Technology Assessment of the Basque Government-OSTEBA), which shall issue a regular report on safety and effectiveness. With the data from the number of current implants, it is considered that a cohort of 140 patients and a minimum follow-up of 24 months is necessary (total duration of study: 38 months) to obtain adequate conclusions.

Project Status: Completed

Year Published: 2017

URL for published report: https://www.ogasun.ejgv.euskadi.eus/r51-catpub/es/k75aWebPublicacionesWar/k75aObtenerPublicacionDigitalServlet?R01HNoPortal=true&N_LIBR=051986&N_EDIC=0001&C_IDIOM=es&FORMATO=.pdf

English language abstract: An English language summary is available

Publication Type: Other

Country: Spain

Organisation Name: Basque Office for Health Technology Assessment

Contact Address: C/ Donostia – San Sebastián, 1 (Edificio Lakua II, 4ª planta) 01010 Vitoria - Gasteiz

Contact Name: Lorea Galnares-Cordero

Contact Email: lgalnares@bioef.eus

Copyright: Osteba (Basque Office for Health Technology Assessment) Health Department of the Basque Government