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Tricuspid Valve Insufficiency clinical trials

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NCT ID: NCT06169345 Completed - Heart Failure Clinical Trials

The Long-term Course of Moderate Tricuspid Regurgitation

LOCOMOTRI
Start date: May 1, 2021
Phase:
Study type: Observational

To evaluate the long-term clinical outcome of a cohort of patients suffering from moderate tricuspid regurgitation (TR), regardless of its etiology.

NCT ID: NCT05854095 Completed - Clinical trials for Functional Tricuspid Regurgitation

The Study for Evaluation of Acute Phase Safety and Efficacy of 'Pivot Bridge' to Short-term Treat FTR

Start date: March 13, 2023
Phase: N/A
Study type: Interventional

evaluation of safety and efficacy of 'Pivot Bridge' to short-term treat Functional Tricuspid regurgitation

NCT ID: NCT05836493 Completed - Clinical trials for Tricuspid Regurgitation

Very Long-term (>15 Years) Results of Tricuspid Valve Repair.

Start date: October 7, 2020
Phase:
Study type: Observational

Interest in Tricuspid valve disease grew exponentially in the last years in response to an increased awareness of the poor outcome of patients with functional Tricuspid Regurgitation (TR). Earlier reports advocated for a more conservative TR management in patients undergoing left-sided heart valve surgery but more recent guidelines advised for a more aggressive TR management, as accumulating evidence demonstrates its adverse impact on long term morbidity and mortality. Several papers have been published analyzing the results of surgical tricuspid valve repair but the length of the follow-up is usually limited to 10 to 12 years. With this study the investigators aim to analyze the very long-term results (>15years) of tricuspid valve repair according to the surgical method employed for valve repair (suture vs ring annuloplasty).

NCT ID: NCT05836415 Completed - Clinical trials for Functional Tricuspid Regurgitation

Effectiveness and Durability Long-term Results of Tricuspid Annuloplasty With 3D Shaped Rings.

Start date: December 2, 2020
Phase:
Study type: Observational

Interest in tricuspid valve disease has grown exponentially over the past few years, in response to increased interest in the poor prognosis of patients with functional tricuspid regurgitation (TR). Tricuspid valve repair (TVR) using a prosthetic ring represents the first option in many centers worldwide, due to the low incidence of residual and recurrent TR and improved survival compared to suture techniques. The goal of ring annuloplasty is to restore the normal geometry of the annulus, thereby improving the coaptation of the leaflets and preventing further dilatation of the annulus. Recently, the three-dimensional geometry of the tricuspid valve has been shown and analyzed by means of data obtained from echocardiography, CT scan and magnetic resonance imaging. Normal tricuspid annulus is characterized by a more prominent part in the anteroseptal commissure area near the aortic valve and right ventricular outflow tract and a deeper part in the posteroseptal commissure area near the coronary sinus ostium . Based on these characteristics, new three-dimensional rings have been developed for tricuspid annuloplasty, such as the MC3 (Edwards Lifescience, Irvine, CA) and the Contour 3D (Medtronic, Minneapolis, MN). There are few studies concerning the short-term results of tricuspid rings implantation and almost none on the long-term, therefore this study aims to analyze the long-term results of TVR by implantation of the two new prosthetic ring models mentioned above. The aim of this study is the long-term analysis of the results of tricuspid annuloplasty with three-dimensional rings in patients with functional IT.

NCT ID: NCT05774821 Completed - Clinical trials for Tricuspid Regurgitation

Surgical Treatment of Tricuspid Valve Regurgitation in Patients With Cardiac Implantable Electronic Devices: Long Term Results

Start date: February 4, 2022
Phase:
Study type: Observational

Old trials aimed to evaluate Implantable Cardioverter-Defibrillator (ICD) safety and efficacy demonstrated a meaningful decreased rates of sudden death but an increased rate of hospitalization for heart failure . At the time, the chance that an endocardial lead could cause a significant tricuspid regurgitation (TR), leading to worsening heart failure, was not widely considered. Whereas, it is now well established that in patients with cardiac implantable electronic device (CIEDs), moderate or severe TR occurs frequently and it is associated with increased mortality and hospitalization for heart failure. The present study aims to report the long-term results of tricuspid valve repair and replacement surgery in patients with CIEDs Indeed, patients with TR and CIEDs can be divided in 2 categories: CIEDs induced TR and CIEDs associated TR. In patients with CIEDs induced TR, the valve dysfunction is directly caused by the lead with several mechanism such as mechanical interference with tricuspid valve (TV) leaflet mobility and coaptation (impingement), valve damage during lead placement or manipulation and sub-valvular entanglement. In patients with CIEDs associated TR the valve dysfunction is not directly caused by the lead. In 2009 approximately 720 000 CIEDs were implanted worldwide [7] and since then a continuous increase of CIEDs implantation was registered, with an estimation of 1.4 millions of CIEDs implantation in 2023. With this impressive number of CIEDs requirement, the need for surgical or trans-catheter treatment of severe TR CIEDs induced or associated, increased steadily in the past years and it likely will continue to increase in the next years. However, limited data are available regarding the outcome of tricuspid valve surgery in patients with CIEDs, particularly for the long-term results. With this study we aim to report the long-term result of tricuspid valve repair and replacement in patients with CIEDs.

NCT ID: NCT05721417 Completed - Clinical trials for Tricuspid Regurgitation

Long-term Outcomes of Isolated Tricuspid Valve Surgery According to Preoperative Clinical and Functional Staging

Start date: February 1, 2022
Phase:
Study type: Observational

Tricuspid regurgitation (TR) was identified as an independent prognostic factor associated with excess mortality and morbidity, independent of left ventricular (LV) function and pulmonary hypertension. Isolated tricuspid surgery has been performed for a long time in a few selected cases, however in recent years several studies have underlined how the poor outcomes described for isolated tricuspid valve surgery seem to be related to the baseline characteristics of the patients and to late referral for surgical treatment rather than the intervention itself. To facilitate patient screening, a new clinical and functional TR staging system has recently been proposed. This classification, which evaluates the progression of morphological variations of the tricuspid valve and right ventricle (RV) in association with the onset of symptoms, identifies several parameters and factors that can be useful for a better stratification of surgical risk. Rather than simply assessing the degree of TR, this new staging mechanism also focuses on symptoms, RV remodeling and function, medical therapy, and right heart failure hospitalizations. Investigators previously focused on the short-term (mainly hospital) outcomes of patients undergoing isolated surgery for severe TR, who were classified at baseline according to this clinical and functional staging system. Results showed that a more comprehensive classification reflects the population and hospital outcomes of surgically treated patients with isolated TR. The purpose of this study is to ultimately evaluate long-term outcomes of this patients population and estimate the impact of baseline staging on long-term outcomes.

NCT ID: NCT05648838 Completed - Clinical trials for Functional Tricuspid Regurgitation

Evaluation of Safety and Efficacy of Pivot Balloon to Monitoring Acute RV Failure and Reduction of FTR

Start date: July 19, 2021
Phase: N/A
Study type: Interventional

Pivot Balloon to monitoring acute RV failure and reduction of Functional Tricuspid Regurgitation

NCT ID: NCT04945005 Completed - Clinical trials for Tricuspid Valve Insufficiency

Prevention of Pacemaker Lead Induced Tricuspid regurgitAtion by Transesophageal eCho guidEd Implantation Registry

PLACE
Start date: November 1, 2019
Phase:
Study type: Observational [Patient Registry]

Registry for patients undergoing pacemaker/ICD implantation including a transtricuspid lead with and without intraprocedural transesophageal echocardiography to evaluate risk factors for lead induced tricuspid regurgitation.

NCT ID: NCT04595448 Completed - Heart Failure Clinical Trials

Lymphatic Function in Patients With Secondary Tricuspid Valve Regurgitation

LYMTRIVA
Start date: September 15, 2020
Phase:
Study type: Observational

The study will examine the lymphatic functional and morphological status in patients with moderate tricuspid valve regurgitation compared to healthy age and gender-matched controls. The study will use t2 weighted MRI, Near-infrared fluorescence imaging, and plethysmography to examine the above-mentioned question.

NCT ID: NCT04414358 Completed - Clinical trials for Residual Tricuspid Regurgitation

Incidence of Residual Tricuspid Regurgitation in Patients Undergoing Left-heart Surgery

Start date: November 20, 2020
Phase:
Study type: Observational

Functional tricuspid valve regurgitation is commonly co-existed with left-sided cardiac lesion, especially mitral valve stenosis. Both lesion were recommended to surgically fixed at the same setting. Residual tricuspid regurgitation may effects patients' outcome. The investigators would like to determine the incidence of significant residual tricuspid regurgitation after left-sided cardiac surgery and related clinical outcome.