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Aortic Stenosis clinical trials

View clinical trials related to Aortic Stenosis.

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NCT ID: NCT03666351 Recruiting - Hypertension Clinical Trials

Study to Evaluate the Effect on Improvement of LVH by the Control of BP in Hypertension Patients With AV Disease

Start date: August 21, 2018
Phase: Phase 4
Study type: Interventional

To compare changes in Left Ventricular Mass (LVM) depending on each blood pressure regulation between the intensive care group and the usual care group for patients with hypertension accompanied by aortic valve disease and evaluate an influence of blood pressure regulation on improvement of left ventricular hypertrophy and its safety

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: NCT03557242 Recruiting - Aortic Stenosis Clinical Trials

Strategies to Prevent Transcatheter Heart Valve Dysfunction in Low Risk Transcatheter Aortic Valve Replacement

Start date: July 5, 2018
Phase: N/A
Study type: Interventional

100 subjects in the each of the treatment arms of the study (total 200 treatment arm subjects) and up to 100 subjects in the registry arm of the study.

NCT ID: NCT03466918 Not yet recruiting - Aortic Stenosis Clinical Trials

Safety and Effectiveness of Edwards Lifesciences SAPIEN 3 Transcatheter Heart Valve (THV) in the Chinese Population

Start date: March 2018
Phase: N/A
Study type: Interventional

To evaluate the safety and effectiveness of the SAPIEN 3 (Edwards Lifesciences, Irvine, California) transcatheter heart valve implantation (TAVI) in Chinese patients with symptomatic severe calcific aortic stenosis who are considered at high risk for surgical valve replacement.

NCT ID: NCT03454360 Recruiting - Aortic Stenosis Clinical Trials

CHANGE Neo™ TA Registry With ACURATE Neo™ Aortic Bioprosthesis and ACURATE Neo™ TA Transapical Delivery System

Start date: February 6, 2018
Phase:
Study type: Observational

The purpose of this registry is to collect specific health and patient data to identify more precisely the patient population undergoing TA aortic valve replacement with the ACURATE neo™ Aortic biprosthesis and ACURATE neo™ TA Transapical Delivery System. Safety and efficacy data will be collected to support the commercial use of the ACURATE neo™ Aortic Bioprosthesis and ACURATE neo™ TA Transapical Delivery System in a specific TA population. As per IFU, the ACURATE neo™ and its ACURATE neo™ TA Delivery System are intended for use in minimally invasive, transcatheter aortic valve replacement using transapical access in patients presenting with severe aortic valve stenosis.

NCT ID: NCT03442400 Recruiting - Aortic Stenosis Clinical Trials

A Prospective Study of Fractional Flow Reserve Assessment of Intermediate Coronary Stenoses in Severe Aortic Stenosis

Start date: February 14, 2018
Phase: N/A
Study type: Interventional

Coronary artery blockages can reduce blood flow to the heart muscle. Fractional flow reserve (iFR or FFR) assessment is an invasive tool used to determine how much blood flow is reduced. The investigators will perform iFR/FFR on all intermediate coronary stenoses using standard practice, immediately before (at the time of) transcatheter aortic valve replacement (TAVR) and after successful TAVR. The investigators will compare pre- and post-TAVR iFR/FFR values, and assess short-term outcomes. The investigators hypothesize that iFR/FFR values will be consistently and significantly higher pre-TAVR in comparison with post-TAVR for the same lesions.

NCT ID: NCT03432494 Enrolling by invitation - Aortic Stenosis Clinical Trials

Transmural Systems Transcaval Closure Device for Transcaval Access Ports During Transcatheter Aortic Valve Replacement

Start date: November 15, 2018
Phase: N/A
Study type: Interventional

Background: TAVR is a common therapy for people with heart problems as a better option than surgery. It stands for transcatheter aortic valve replacement. It is usually done by inserting a catheter (thin tube) through a groin artery. But this isn t safe for everyone. Researchers developed a new technique called transcaval access. The catheter is placed in the artery deep in the body by crossing through the wall of a deep vein. The connection between that vein and the aorta is closed with a new metallic device they are testing. This is called a transcaval closure device (TCD). Objective: To test the safety and early feasibility of closure of transcaval aortic access sites using the TCD after TAVR. Eligibility: Adults ages 21 and older undergoing TAVR for whom the procedure cannot be performed safely by the standard artery approach Design: Participants will be assessed by heart experts including cardiologists and surgeons. Participants will have TAVR by the transcaval approach. A small catheter will be passed between the largest vein in the body and the nearby largest artery (aorta), inside the abdomen. Through this catheter, the TAVR will be implanted in the usual way. After, doctors will implant the TCD by catheter to close the hole made in the aorta. Participants will be X-rayed. A dye will be injected to view the TCD device. Participants will get standard TAVR care afterwards. They will have physical exams, blood tests, and scans. Participants will have a follow-up scan within 1 month and after 12 months. Participants will have follow-up visits and phone calls 6 and 12 months after the procedure.

NCT ID: NCT03424941 Recruiting - Aortic Stenosis Clinical Trials

The TransCatheter Valve and Vessels Trial

TCW
Start date: May 31, 2018
Phase: N/A
Study type: Interventional

The trial objective is to investigate whether Fractional Flow Reserve (FFR)-Guided Percutaneous Coronary Intervention (PCI) and TransCatheter Aortic Valve Implantation (TAVI) strategy for treatment of multivessel disease and aortic stenosis will be non-inferior to Coronary Artery By-pass Grafting (CABG) and Surgical Aortic Valve Replacement (SAVR) for a composite primary endpoint of all-cause mortality, stroke, myocardial infarction, coronary or valve re-intervention and life-threatening or disabling bleeding at one year.

NCT ID: NCT03423459 Recruiting - Aortic Stenosis Clinical Trials

CoreValve Evolut Pro Registry

Start date: January 18, 2018
Phase: N/A
Study type: Observational [Patient Registry]

The primary objective of this study is to evaluate the real-world performance of the CoreValve Evolut PRO transcatheter aortic valve, including leaflet function, in a prospective observational registry.

NCT ID: NCT03383445 Recruiting - Aortic Stenosis Clinical Trials

Transcatheter Aortic Valve Replacement Versu Surgical Aortix Valve Replacement for Treating Elderly Patients With Severe Aortic Stenosis and Small Aortic Annuli: A Prospective Randomized Study The VIVA Trial

Start date: May 30, 2017
Phase: N/A
Study type: Interventional

To date, no formal, randomized, prospective, head-to-head comparisons of surgical aortic valve replacement (SAVR) versus transcatheter aortic valve replacement (TAVR) have been undertaken in the severe aortic stenosis (AS) population with small aortic annuli. Objectives of the present study are to compare the hemodynamic performance (incidence of severe PPM and ≥ moderate AR) and clinical outcomes (death, stroke, major or life threatening bleeding) between TAVR and SAVR in patients with severe AS and small aortic annuli.