Barcelona Clinical Coordinating Center (BCCC), acting as the national coordinating contract research organization (CRO) for Spain, celebrates the successful completion of patient recruitment in the PRIMARY study evaluating the long-term safety and effectiveness of transcatheter edge-to-edge repair (TEER) compared with surgical repair in patients with primary degenerative mitral regurgitation. Sponsored by the National Institutes of Health (NIH, USA), the study has successfully enrolled 450 patients worldwide, including 29 participants recruited in Spain.
This global, multicenter, randomized controlled study compares the long-term safety and effectiveness of mitral valve transcatheter edge-to-edge repair (TEER) compared with surgical repair in patients with primary, degenerative mitral regurgitation. Patients are prospectively randomized in a 1:1 ratio to either treatment strategy, generating high-quality evidence to inform the management of this complex valvular heart disease.
The completion of patient recruitment represents a key milestone in the development of the study and paves the way for the next phases of clinical follow-up and data analysis.
In Spain, the study has been led by Dr. Daniel Pereda and Dr, Xavier Freixa as National Coordinators. Spanish sites have made a significant contribution to the study enrolling 29 patients, including 21 randomized participants across five hospitals in Spain. The successful completion of recruitment highlights the strong collaboration among participating sites, the international sponsor, and BCCC as the coordinating CRO for Spain.
“Achieving this global recruitment milestone is a clear reflection of the coordinated effort across all teams involved. At BCCC we are particularly proud of the contribution made by the Spanish sites and of our role in coordinating their participation in a study of significant scientific and clinical importance,” said Dr Josep Rodés-Cabau (Chief Scientific Officer at BCCC).
About National Institutes of Health (NIH)
The National Institutes of Health is the primary agency of the United States federal government responsible for biomedical and public health research.
About Barcelona Clinical Coordinating Center (BCCC).
Barcelona Clinical Coordinating Center is a European non-profit CRO specializing in the coordination and management of clinical research projects, providing expertise in trial design, site management, data coordination, as well as regulatory and statistical consulting services.
Acknowledgment
Research reported in this press release was supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health under award number U01 HL088942.
The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
