View clinical trials related to Tricuspid Valve Insufficiency.
Filter by:To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Repair System in patients with symptomatic severe tricuspid regurgitation who have been determined to be at an intermediate or greater estimated risk of mortality with tricuspid valve surgery by the cardiac surgeon with concurrence by the local Heart Team
Tricuspid regurgitation is common in patients with heart valve disease, both flexible band and rigid ring annuloplasty can correct this anomaly. However, there is no data to address which one can bring more benefits to these patients with combined heart valve disease. This study aims to prospectively compare the efficacy and long term outcomes of flexible band versus rigid ring annuloplasty for the correction of tricuspid regurgitation.
This study includes 105 patients who underwent repair for ≥ moderate tricuspid regurgitation (TR) during mitral valve replacement for rheumatic valve disease. Between January 2016 and December 2018, a group of 23 patients underwent ring annuloplasty with Edward MC3 rings were compared to another group of 82 patients underwent standard suture (DeVega) repair. The primary outcome was residual TR (≥ moderate TR).
The Mistral is an investigational device intended for percutaneous trans-catheter repair in high risk for surgery individuals suffering from functional Tricuspid Regurgitation (TR). The device system is to be used only in accordance with the approved Investigational Plan on subjects who have signed an informed consent form. Device use is limited to the approved study investigators.
The Mistral is an investigational device intended for percutaneous trans-catheter repair in high risk for surgery individuals suffering from functional Tricuspid Regurgitation (TR). The device system is to be used only in accordance with the approved Investigational Plan on subjects who have signed an informed consent form. Device use is limited to the approved study investigators.
Currently, in cardiology/cardiosurgery the indicators for the surgical correction of secondary tricuspid regurgitationare unclear. AIM: To compare right ventricle structural and functional changes after operation in patients with secondary tricuspid regurgitation with severe mitral /aortic valve pathology, requiring surgical intervention; define the factors influencing major adverse cardiac events depending on the operation/non-operation due to moderate tricuspid regurgitation. This study intends to include 200-300 people and will occur over 5 years with an additional 3-year follow-up.
Background: Treatments for structural heart and valve disease are quickly changing. But treatment could be improved. Researchers want to gather data from people with this disease. They want to find problems and seek new ways to make treatments better. Objective: To find people with structural heart and valve disease with common features to study. To find flaws and patterns in procedures related to this disease. To share findings with other researchers. Eligibility: People ages 18 and older who are receiving care from the structural heart and valve program at the participating NHLBI structural heart disease network sites that are part of the study Design: Participants will be screened with their consent. This will occur when they give their standard consent for medical care. Participants will have their data collected in the course of standard medical care. Data include: Demographic data Protected health data Personally identifiable data Medical records Medical images. These could include X-rays, CT scans, and MRI scans. The study could find something that would impact participants care. If this is the case, their doctors will be told. Participants data may be shared with other researchers. ...
The primary objective of this trial is to demonstrate the safety and effectiveness of the TriClip device in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR), who are at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve surgery. This randomized controlled trial will compare the investigational device (TriClip device) to Control (Medical Therapy).
The purpose of the study is to assess the safety and the effectiveness of the Cardioband Tricuspid Reconstruction System.
The purpose of this study is to determine the utility of tricuspid valve repair at the time of LVAD implantation for patients presenting with moderate or severe tricuspid regurgitation. The study will be a randomized trial for patients presenting for LVAD implantation to either tricuspid valve repair or no tricuspid valve repair. The data will be analyzed as both an intention to treat analysis as well as an "as treated" analysis with the primary outcome being rates of right ventricular dysfunction post LVAD implantation. Tricuspid valve repair for these patient is currently being done for some patients, without any strong data to either support such practice or negate it.