View clinical trials related to Tricuspid Valve Insufficiency.
Filter by:The purpose of this study to identify the efficacy of sodium glucose cotransporter 2 inhibitors add-on treatment on right ventricular remodeling and the amount of severe tricuspid regurgitation (TR) in patients with isolated severe TR.
This study is a prospective design. Patients are severe tricuspid regurgitation (TR) (≥ 3+) who remained clinically symptomatic after guideline-directed medical treatment. After signing an informed consent form, subjects are enrolled and treated with the DragonFly-T Transcatheter Tricuspid Valve Repair System. All subjects receive clinical follow-up immediately after the procedure, before discharge, 30 days after the procedure, 6 months after the procedure, 12 months, and 2, 3, 4, and 5 years after the procedure. The incidence of MAEs (Major Adverse Events) at 30 days is used as the safety endpoint. The MAEs include stroke, cardiovascular death, new renal failure, endocarditis requiring surgery, and non-elective cardiovascular interventions due to device-related adverse events. The efficacy endpoints include acute procedural success, acute device success, the incidence of all-cause mortality and/or heart failure rehospitalization at 12 months after the procedure, the percentage of patients with tricuspid regurgitation of 2+ or less, the percentage of patients with tricuspid regurgitation reduced by at least one grade, the improvement in 6 minutes walk test, New York Heart Association (NYHA) class, quality of life change as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) score and change in edema scale grading.
This is the first randomized controlled trial comparing transesophageal echocardiography + fluoroscopy guided lead implantation vs. standard lead implantation guided by fluoroscopy only. Patients are randomized 1:1 in the two groups and followed up for up to 3 years.
Pivot Balloon to monitoring acute RV failure and reduction of Functional Tricuspid Regurgitation
This is a national multicenter, open-label, randomized controlled trial to show superiority of edge-to-edge Transcatheter Tricuspid Valve repair (TTVr) on top of the Standard Of Care (SOC; heart failure medication) over the SOC alone in patients with symptomatic severe Tricuspid Regurgitation (TR) in the Netherlands.
Tricuspid regurgitation is common in patients with severe left heart diseases, such as degenerative mitral regurgitation. However, the evidence base is insufficient to inform a decision about whether to perform concomitant tricuspid-valve repair during left heart surgery in patients who have mild tricuspid regurgitation. To inform decision making, we will conduct a multicenter, randomized trial to assess the benefits and risks of tricuspid-valve repair at the time of left heart diseases in patients with mild tricuspid regurgitation who were undergoing surgery for left heart surgery.
In this study, patients who have undergone or will undergo a transcatheter edge-to-edge repair (TEER) for tricuspid valve regurgitation (TR) will be followed up for 5 years. The goal of this prospective and retrospective, observational, non-randomized, multicenter registry is to confirm that TEER is a feasible, safe and effective treatment option for TR and to evaluate the long-term efficacy and safety of TEER. The main endpoints are: - Change in tricuspid regurgitation grade: number of patients with a reduction in tricuspid regurgitation score by at least one grade - Composite of major adverse event: number of patients with composite of major adverse event (cardiovascular mortality, acute kidney injury, myocardial infarction, stroke or TIA, coronary revascularization, new onset AF or ventricular arrhythmia)
To confirm the effectiveness and safety of the DragonFly-T transcatheter tricuspid valve repair system for the treatment of severe tricuspid regurgitation (TR) (TR grade ≥ 3+) who remained clinically symptomatic after guideline-directed medical treatment.
The purpose of this study is to objectively assess the impact of the pathology on the patient's life so as to best inform the choices of evaluators "the French National Authority for Health" (HAS) and decision makers "the Economics Committee for Health Products" (CEPS) through the expression of the patients' feelings themselves. For this, the study will assess the impact of severe tricuspid insufficiency and its symptoms on the quality of life of patients from a physical, psychological and social point of view.
To evaluate the safety and effectiveness of Dawneo Neoblazar® transcatheter tricuspid valve edge-to-edge repair system in patients with severe tricuspid regurgitation. This is a prospective, multicenter, randomized, objective performance criteria trial. 98 patients who meet the inclusion criteria will be included in the study. This study will be conducted in in each site as run-in subjects. Subjects who meet the requirements and who voluntarily participate in the trial and sign the informed consent form, will be implanted with the Neoblazar® Transcatheter Tricuspid Valve Edge-to Edge Repair System.