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Heart Valve Diseases clinical trials

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NCT ID: NCT04761120 Recruiting - Clinical trials for Mitral Regurgitation

Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study

ARB-PMCF
Start date: February 1, 2021
Phase:
Study type: Observational

ARB-PMCF is a multicenter, observational study of the safety and performance of Abbott annuloplasty devices used in surgical repair of mitral and tricuspid valve regurgitation. The devices included in this study are the SJM™ Rigid Saddle Ring and SJM Séguin Annuloplasty Ring, indicated for mitral valve repair, and the SJM Tailor™ Annuloplasty Ring and SJM Tailor Annuloplasty Band, indicated for mitral or tricuspid repair. Participants will be enrolled prior to undergoing mitral or tricuspid valve repair surgery including an Abbott annuloplasty implant and will complete annual follow-up visits through five years from implant. The study is being conducted to meet post-market clinical follow-up requirements of the European Union Medical Device Directives.

NCT ID: NCT04571372 Recruiting - Clinical trials for Severe Aortic Stenosis or Severe Aortic Regurgitation

Prognostic Value of Soluble Urokinase-type Plasminogen Activator Receptor in Valvular Heart Disease

Start date: September 23, 2020
Phase:
Study type: Observational

This study investigates the association between level of suPAR and valvular heart disease in patients who have severe aortic stenosis or severe aortic regurgitation using commercially available suPARnostic standard enzyme-linked immunosorbent assay (ViroGates, Denmark)

NCT ID: NCT04482062 Recruiting - Heart Failure Clinical Trials

TRISCEND II Pivotal Trial

Start date: April 9, 2021
Phase: N/A
Study type: Interventional

Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system

NCT ID: NCT04454177 Recruiting - Aortic Stenosis Clinical Trials

SMART Watch Facilitated Early Discharge in Patients Undergoing Transcatheter Aortic Valve Replacement

SMART TAVR
Start date: July 15, 2020
Phase:
Study type: Observational

The purpose of this study is to observe conduction disturbance, daily activity level, heart rates, oxygen saturation in patients who underwent Transcatheter Aortic Valve Replacement (TAVR) and to evaluate the utility of the HUAWEI Watch (HUAWEI Technologies Co., Ltd., Shenzhen, China) for the potential early warning sign of changes in multiple biometric parameters including heart rate, rhythm, oxygen saturation, activity, and sleep in patients following TAVR. This will be evaluated in the context of a recently implemented early discharge protocol.

NCT ID: NCT04445012 Recruiting - Clinical trials for Heart Valve Diseases

Cardiovascular Acoustics and an Intelligent Stethoscope

CAIS
Start date: October 24, 2019
Phase:
Study type: Observational

The aim of the project is to develop an artificial intelligence software capable of analysing heart sounds to provide early diagnosis of a variety heart diseases at an early stage. Since the invention of the stethoscope by Laennec in 1816, the basic design has not changed significantly. Our software could be coupled with existing electronic stethoscopes to create an 'intelligent' stethoscope that could be used by healthcare assistants or practice nurses to screen for sound producing heart diseases. It could also be used at home by patients who would otherwise go undiagnosed. The study investigators at Cambridge University Engineering Department (CUED) have developed a proof-of-concept AI algorithm to detect heart murmurs. However, in order to accurately detect the specific pathology and severity underlying the murmur, more heart sound recordings (matched with the ground truth from the patient's echocardiogram) are required. Patients presenting to one of the partner hospitals requiring an echocardiogram as part of their routine care will be invited to consent to this study. Participation will entail recording of a patient's heart sounds using an electronic stethoscope as well as collection of routine clinical data and a routine clinical echocardiogram at a single routine out patient visit.

NCT ID: NCT04442100 Recruiting - Clinical trials for Heart Valve Diseases

The Study of Biological Prosthetic Heart Valves With the "Easy Change" System

Start date: November 29, 2016
Phase: N/A
Study type: Interventional

The study of new biological heart valves with the "easy change" system, including an assessment of the basic hemodynamic characteristics of the prosthesis, complications associated with valve implantation, and general mortality

NCT ID: NCT04408430 Recruiting - Clinical trials for Mitral Regurgitation

The MITRAL II Pivotal Trial (Mitral Implantation of TRAnscatheter vaLves).

MITRAL-II
Start date: March 8, 2021
Phase: N/A
Study type: Interventional

A prospective multicenter study enrolling high surgical risk patients with severe mitral annular calcification (MAC) and symptomatic mitral valve dysfunction (severe stenosis, ≥ moderate to severe regurgitation, or mixed ≥ moderate stenosis and ≥ regurgitation). There are 2 Arms in this study: 1) "Transseptal (TS) Valve-in-MAC" (ViMAC) Arm, and 2) Natural History of Disease Registry (NHDR) for patients treated with medical treatment only (which includes patients who meet inclusion criteria but can't be treated with transeptal ViMAC due to the presence of anatomical exclusion criteria or other exclusion criteria) and have not had other procedures that may impact outcomes (i.e., alcohol septal ablation or radiofrequency ablation). The study also includes a Registry of Permanently Unassigned" for subjects who undergo preemptive septal ablation procedures (alcohol or radiofrequency) in anticipation of continuing onto ViMAC arm, but are not accepted in the ViMAC Study arm or the patient chooses not to undergo ViMAC procedure.

NCT ID: NCT04359030 Recruiting - Clinical trials for Aortic Valve Disease

Freestyle-Perimount Calcification Comparison

Start date: November 15, 2021
Phase:
Study type: Observational

The aim of this study is to evaluate the rate and anatomy of the aortic wall and leaflet calcification of the FS prosthesis implanted as full root in patients younger than 60 years compared to a stented bioprostheses (Perimount Magna Ease, PM). A 3D CT scan will be used to assess the calcification score and to determine the relationship between calcification and aortic valve leaflet.

NCT ID: NCT04190602 Recruiting - Clinical trials for Mitral Regurgitation

Multicenter Post-Market Observational Registry of the NeoChord Artificial Chordae Delivery System

AcChord
Start date: February 9, 2020
Phase:
Study type: Observational [Patient Registry]

The objective of this study is to evaluate the 5-year outcomes of participants with degenerative mitral valve disease treated with the NeoChord Artificial Chordae System, Model DS1000 in a post-market setting.

NCT ID: NCT04149600 Recruiting - Clinical trials for Aortic Valve Disease

Identification of Genetic Causes of Calcific Aortic Valve Disease

Start date: September 25, 2018
Phase:
Study type: Observational

This study aims to identify the molecular genetic causes of the variability in development of calcific aortic valve disease in bicuspid and tricuspid aortic valves and their associated aortic dilation.