View clinical trials related to Mitral Insufficiency.
Filter by:The aim of PLUTO-II is to use biventricular pressure-volume (PV) loop measurements to improve the understanding of direct changes in cardiac and hemodynamic physiology induced by transcatheter aortic valve implantation (TAVI) or tricuspid edge-to-edge repair (TEER). These procedures evoke immediate changes in cardiac mechanoenergetics, ventricular-vascular interaction as well as ventricular (in)dependency. Within the context of PLUTO-II, patients will undergo biventricular PV-loop measurements before and after TAVI or TEER. In future, the application of perprocedural PV loop monitoring may tailor the daily individual decision making process during structural interventions in the catheterization laboratory.
In recent years increasing number of mitral bioprosthesis implantation, especially in elderly population, is observed. Bioprosthetic valves are associated with a lower risk of thrombotic and bleeding adverse events compared with mechanical prostheses, but their use is limited due to their durability. After years numerous patients may develop bioprosthesis failure, requiring valve reintervention. Significantly burdened ones are oftentimes disqualified or not referred to surgery redo. An emerging treatment method for these patients is transcatheter mitral valve-in-valve implantation as an alternative to re-operation. This technique is applied with the use of devices previously dedicated to transcatheter aortic valve implantation (TAVI). Recent papers prove that transcatheter mitral valve replacement (TMVR) is a safe and effective procedure when performed in a selected group of high-surgical-risk patients. However, data regarding the Polish population are limited. Therefore, the aim of the study is to create a nationwide registry, collecting data from all Polish centers performing TMVR in order to describe the population of patients developing mitral bioprosthesis failure, evaluate their follow-up after TMVR as well as results of the transcatheter valvular intervention and identify potential limitations of the procedure.
this research is based on the hypothesis that the measurement of the ratio of mean arterial pressure to mean left atrium pressure and of its evolution during the procedure, would make it possible to assess the immediate success of the procedure by supplementing the results of the ultrasound. The main objective of this research is to define the percentage of improvement in the mean arterial pressure / mean left atrium pressure ratio at the end of the procedure to validate the success of the MitraClip procedure.
This is a postmarket clinical follow up study on the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System in transcatheter mitral valve repair.
Barlow disease (BD) is a common cause of mitral insufficiency. In 2012 the University Hospital of Basel started to perform a simplified mitral valve repair technique in BD just by implanting an annuloplasty-ring. It is hypothesized that the major mechanism of the valvular insufficiency in Barlow disease is a deformation of the left ventricle and the posterior mitral annulus, causing its aberrant displacement during the systole towards posterior and basal and thus impairing the coaptation of the leaflets. This prospective individual MRI study is to investigate the ventricle and the mitral annulus pre- and postoperatively for detailed analysis.
Prospective, single-arm, multicenter study to evaluate the safety and performance of the AltaValve for the treatment of moderate to severe or severe mitral valve regurgitation in subjects who are considered high risk for mortality and morbidity from conventional open-heart surgery.
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT)
Congenital mitral insufficiency is one of the most common valvular diseases in the pediatric population worldwide, carrying a high morbidity and mortality risk if not treated immediately and properly. Given that mitral replacement likely increased risk of cardiac dysfunction and mitral reoperation, mitral repair is the currently preferred surgical strategy in the majority of pediatric patients with mitral insufficiency. Unfortunately, previous evidences demonstrated the long-term hemodynamic alteration in response to significant mitral regurgitant might lead to a reversible or irreversible pulmonary vascular remodeling regardless of concomitant other cardiac malformations, which is associated with increased risk of morbidity and mortality following the surgery. Currently available researches mainly focused the association of pulmonary vascular pressures with risk of mortality and morbidity on adult rheumatic or degenerative mitral insufficiency; however, knowledge is still lacking regarding pediatric population with congenital mitral insufficiency. The investigator wil assess the relationship between baseline sPAP and risk of operative morbidity and mortality.
Prospective, controlled, multicenter clinical investigation with four trial cohorts: Randomized, Non-repairable, Severe Mitral Annular Calcification (MAC) and Severe Mitral Annular Calcification Continued Access Protocol (MAC CAP). Subjects in the Randomized cohort will be randomized in a 1:1 ratio to the trial device or to the MitraClip system. Subjects in the Non-repairable, Severe MAC, and Severe MAC CAP cohorts will receive the trial device. The objective of the Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (SUMMIT) is to evaluate the safety and effectiveness of the Tendyne Transcatheter Mitral Valve System for the treatment of patients with symptomatic, moderate-to-severe or severe mitral regurgitation or for patients with symptomatic mitral valve disease due to severe mitral annular calcification. This randomized controlled trial will provide the opportunity to evaluate the safety and clinical benefits of the Tendyne Transcatheter Mitral Valve System compared to the MitraClip System in patients with symptomatic, moderate-to-severe or severe mitral regurgitation, within approved MitraClip indications. In addition, the safety and effectiveness of the Tendyne Transcatheter Mitral Valve System will be evaluated in patients with severe mitral annular calcification who are at prohibitive risk for mitral valve surgery. Patients who are not suitable for mitral valve surgery for reasons other than severe mitral annular calcification and are also not suitable for transcatheter repair with MitraClip, will be enrolled in the Non-repairable cohort. Subjects will be seen at screening, pre- and post-procedure, discharge, 30 days, 3 months, 6 months, and annually through 5 years.
The purpose of the study is to generate early US feasibility data of the CardiAQ™ Transcatheter Mitral Valve Implant System. The study will enroll patients with moderate to severe mitral valve regurgitation who are considered high risk for mortality and morbidity from conventional open-heart surgery.