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Tricuspid Valve Insufficiency clinical trials

View clinical trials related to Tricuspid Valve Insufficiency.

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NCT ID: NCT04400513 Completed - Clinical trials for Aortic Valve Stenosis

Development of an Algorithm to Differentiate Heart Murmurs Using Electronic Stethoscopes

Start date: June 25, 2020
Phase:
Study type: Observational

The Eko CORE and DUO stethoscopes are FDA-approved electronic devices that have the capacity to record heart sounds. The study seeks to expand murmur detection to include VHD classification through the development of novel ML algorithms that are able to distinguish between systolic vs. diastolic vs. continuous murmurs, as well as classify VHD type and severity, using 4-point auscultation with Eko CORE and DUO electronic stethoscopes to record heart sounds.

NCT ID: NCT04141137 Completed - Clinical trials for Severe Tricuspid Regurgitation

TRICUS STUDY Euro - Safety and Efficacy of the TricValve® Device

Start date: December 9, 2019
Phase: N/A
Study type: Interventional

The TricValve® Transcatheter Bicaval Valves System is indicated for relief of tricuspid insufficiency in patients with symptomatic heart disease who are judged by a heart team, including a cardiac surgeon, to be at extreme risk or inoperable for open surgical therapy.

NCT ID: NCT04078867 Completed - Clinical trials for Functional Tricuspid Regurgitation

Outcome of MC3 Ring Annuloplasty for Functional Tricuspid Regurgitation

Start date: January 1, 2016
Phase:
Study type: Observational [Patient Registry]

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).

NCT ID: NCT04073979 Completed - Clinical trials for Tricuspid Valve Regurgitation

MATTERS II - Mistral Percutaneous Tricuspid Valve Repair FIM Study

Start date: April 2, 2019
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04071652 Completed - Clinical trials for Tricuspid Valve Regurgitation

MATTERS Study - Mistral Percutaneous Tricuspid Valve Repair FIM Study

Start date: August 8, 2017
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03775759 Completed - Heart Failure Clinical Trials

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

TVVAD
Start date: August 22, 2018
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03723239 Completed - Clinical trials for Severe Tricuspid Regurgitation

TRICUS STUDY - Safety and Efficacy of the TricValve® Device

Start date: September 12, 2018
Phase: N/A
Study type: Interventional

The TricValve® Transcatheter Bicaval Valves System is indicated for relief of tricuspid insufficiency in patients with symptomatic heart disease who are judged by a heart team, including a cardiac surgeon, to be at extreme risk or inoperable for open surgical therapy.

NCT ID: NCT03604484 Completed - Clinical trials for Tricuspid Valve Insufficiency

Prophylactic Tricuspid Annuloplasty During Mitral Valve Surgery

Start date: May 1, 2009
Phase: N/A
Study type: Interventional

Single center randomized study to test whether a prophylactic tricuspid annuloplasty at the time of mitral valve procedure can improve clinical and echocardiographical outcomes.

NCT ID: NCT03600051 Completed - Aortic Stenosis Clinical Trials

Automated Phonocardiography Analysis in Adults

Start date: December 10, 2015
Phase:
Study type: Observational

Background: Computer aided auscultation in the differentiation of pathologic (AHA class I) from no- or innocent murmurs (AHA class III) via artificial intelligence algorithms could be a useful tool to assist healthcare providers in identifying pathological heart murmurs and may avoid unnecessary referrals to medical specialists. Objective: Assess the quality of the artificial intelligence (AI) algorithm that autonomously detects and classifies heart murmurs as either pathologic (AHA class I) or as no- or innocent (AHA class III). Hypothesis: The algorithm used in this study is able to analyze and identify pathologic heart murmurs (AHA class I) in an adult population with valve defects with a similar sensitivity compared to medical specialist. Methods: Each patient is auscultated and diagnosed independently by a medical specialist by means of standard auscultation. Auscultation findings are verified via gold-standard echocardiogram diagnosis. For each patient, a phonocardiogram (PCG) - a digital recording of the heart sounds - is acquired. The recordings are later analyzed using the AI algorithm. The algorithm results are compared to the findings of the medical professionals as well as to the echocardiogram findings.

NCT ID: NCT03270514 Completed - Clinical trials for Coronary Artery Disease

Comparison of Sternal Wound Infiltration With Liposomal Bupivacaine v. Bupivacaine Hydrochloride

Start date: November 15, 2018
Phase: Phase 3
Study type: Interventional

The aim of this study is to evaluate the analgesic efficacy and safety of wound infiltration with liposomal bupivacaine (LB) in patients undergoing cardiac surgery with sternotomy and cardiopulmonary bypass (CPB) and compare it with bupivacaine hydrochloride infiltration