Topics

The SPACER Trial - Repair of Tricuspid Valve Regurgitation Using the Edwards TricuSPid TrAnsCatheter REpaiR System

2016-06-01 15:23:22 | BioPortfolio

Summary

The purpose of the study is to assess the safety and device performance of the Edwards Tricuspid Transcatheter Repair System in patients with clinically significant, symptomatic, tricuspid regurgitation who are at high surgical risk for standard tricuspid repair/replacement.

Description

The purpose of the study is to assess the safety and device performance of the Edwards Tricuspid Transcatheter Repair System in patients with clinically significant, symptomatic, tricuspid regurgitation who are at high surgical risk for standard tricuspid repair/replacement. The study is a multi-center, international, prospective, single arm, safety study. Enrolled subjects will be assessed for clinical follow-up at 1 month, 6 months, 1 year and annually for 3 years post implant procedure.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Tricuspid Valve Regurgitation

Intervention

EW Tricuspid Transcatheter Repair System

Location

St. Paul's Hospital, Providence Health Care Research Institute
Vancouver
British Columbia
Canada
V6E 1M7

Status

Not yet recruiting

Source

Edwards Lifesciences

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-06-01T15:23:22-0400

Clinical Trials [1619 Associated Clinical Trials listed on BioPortfolio]

Evaluation of Treatment With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater Tricuspid Regurgitation (TRILUMINATE)

The primary purpose of this study is to evaluate safety and effectiveness of the Tricuspid Valve Repair System (TVRS) for treating symptomatic moderate or greater tricuspid regurgitation (...

Transcatheter Repair of Tricuspid Regurgitation With Edwards Cardioband TR System Post Market Study (TriBAND)

To demonstrate reduction of TR with durable performance and improvements in functional status

Treatment of Tricuspid Valve Regurgitation in Patients Undergoing Left Ventricular Assist Device Implantation Study

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. Th...

MitraClip for Severe TR

The aim of this study was to investigate the procedural feasibility and 30-day results of transcatheter tricuspid valve repair using the MitraClip® system (Abbott Vascular) in selected, h...

Percutaneous Treatment of Tricuspid Valve Regurgitation With the TriCinch System™

The TriCinch System™ is intended for percutaneous treatment of tricuspid regurgitation. It is a percutaneous catheter-based device designed for tricuspid valve repair in order to decrea...

PubMed Articles [11179 Associated PubMed Articles listed on BioPortfolio]

Transcatheter innovations in tricuspid regurgitation: Navigate.

Patients with isolated functional or recurrent tricuspid regurgitation are often considered high risk and denied surgery. There has been growing experience for transcatheter tricuspid valve implantati...

Combined Tricuspid and Mitral Versus Isolated Mitral Valve Repair for Severe Mitral and Tricuspid Regurgitation: An Analysis From the TriValve and TRAMI Registries.

The aim of this study was to retrospectively compare the characteristics, procedural courses, and outcomes of patients presenting with concomitant mitral regurgitation (MR) and tricuspid regurgitation...

Clinical characteristics, diagnosis, and risk stratification of pulmonary hypertension in severe tricuspid regurgitation and implications for transcatheter tricuspid valve repair.

Patients with pulmonary hypertension (PHT) are often excluded from surgical therapies for tricuspid regurgitation (TR). Transcatheter tricuspid valve repair (TTVR) with the MitraClip™ technique is a...

Transcatheter versus medical treatment of symptomatic severe tricuspid regurgitation.

Tricuspid Regurgitation (TR) is associated with increased rates of heart failure (HF) and mortality. Transcatheter tricuspid valve interventions (TTVI) are promising, but the clinical benefit is unkno...

Outcomes of Guideline-Directed Concomitant Annuloplasty for Functional Tricuspid Regurgitation.

Despite guideline recommendations, rates of concomitant tricuspid valve repair are suboptimal, possibly due to fear of complications. We reviewed morbidity, mortality, recurrent tricuspid regurgitatio...

Medical and Biotech [MESH] Definitions

Abnormal protrusion of one or more of the leaflets of TRICUSPID VALVE into the RIGHT ATRIUM during SYSTOLE. This allows the backflow of blood into right atrium leading to TRICUSPID VALVE INSUFFICIENCY; SYSTOLIC MURMURS. Its most common cause is not primary valve abnormality but rather the dilation of the RIGHT VENTRICLE and the tricuspid annulus.

The pathologic narrowing of the orifice of the TRICUSPID VALVE. This hinders the emptying of RIGHT ATRIUM leading to elevated right atrial pressure and systemic venous congestion. Tricuspid valve stenosis is almost always due to RHEUMATIC FEVER.

Backflow of blood from the RIGHT VENTRICLE into the RIGHT ATRIUM due to imperfect closure of the TRICUSPID VALVE.

Cardiac manifestation of gastrointestinal CARCINOID TUMOR that metastasizes to the liver. Substances secreted by the tumor cells, including SEROTONIN, promote fibrous plaque formation in ENDOCARDIUM and its underlying layers. These deposits cause distortion of the TRICUSPID VALVE and the PULMONARY VALVE eventually leading to STENOSIS and valve regurgitation.

The valve consisting of three cusps situated between the right atrium and right ventricle of the heart.

More From BioPortfolio on "The SPACER Trial - Repair of Tricuspid Valve Regurgitation Using the Edwards TricuSPid TrAnsCatheter REpaiR System"

Quick Search

Relevant Topic

Surgical treatments
Surgery is a technology consisting of a physical intervention on tissues. All forms of surgery are considered invasive procedures; so-called "noninvasive surgery" usually refers to an excision that does not penetrate the structure being exci...


Searches Linking to this Trial