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Aortic Valve Stenosis clinical trials

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NCT ID: NCT04573049 Recruiting - Heart Failure Clinical Trials

The Effectiveness and Safety of Levosimendan in Patients With Severe Aortic Stenosis and Heart Failure Undergoing Transcatheter Aortic Valve Replacement

Start date: September 1, 2020
Phase: Phase 4
Study type: Interventional

A study to evaluate the effectiveness and safety of levosimendan compared with placebo in subjects with severe aortic stenosis and heart failure undergoing transcatheter aortic valve replacement

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: NCT04552275 Recruiting - Aortic Stenosis Clinical Trials

The HALT Biomarker Study

HALT
Start date: June 22, 2020
Phase: Phase 1
Study type: Interventional

The purpose of the HALT Biomarkers study are to identify a panel of circulating proteins that discriminates between patients with and without Hypo-Attenuated Leaflet Thickening (HALT) and can be used to supplement the diagnosis of HALT; to characterize changes in circulating proteins after treatment of HALT with systemic anticoagulation; and to identify circulating proteins that predict the occurrence of HALT. The study population will be adult patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS) or bioprosthetic valve degeneration. Enrollment will continue until 30 patients with HALT are identified for completion of phase 1. Based on a HALT incidence rate of 10%, we anticipate enrolling 300 patients. Patients are enrolled prior to undergoing transfemoral TAVR. Blood samples, clinical data and echocardiograms will be collected at the following timepoints: baseline (pre-TAVR, T0), post-TAVR (pre-discharge, T1), 30-day follow-up (window 3-9 weeks, T2), and 6-month follow-up (T3). Cardiac 4D CT will be performed at the 30-day follow-up visit to screen for the occurrence of HALT. Patients with HALT will be treated with systemic anticoagulation for 5-6 months, at which point a follow-up CT scan and blood sample will be obtained. Control subjects will also undergo a 6-month study visit with blood sample collection. The study will be conducted within two phases. Phase 1 will serve as a derivation / discovery study in which candidate protein biomarkers of HALT will be identified. Once this is successfully completed, a second cohort will be enrolled within phase 2. Phase 2 will be performed under the auspices a future contract or amendment and will seek to cross-validate the initial study findings.

NCT ID: NCT04533282 Recruiting - Clinical trials for Coronary Artery Disease

Epitranscriptomic Blood Biomarkers for Coronary Artery Disease - A Prospective Cohort Study (IHD-EPITRAN)

IHD-EPITRAN
Start date: November 10, 2020
Phase:
Study type: Observational [Patient Registry]

Despite advancements in medical care, ischemic heart disease (IHD) remains the leading global cause of death. IHD develops through lipid accumulation into the coronary arteries with subsequent formation of larger atherogenic plaques. During myocardial infarction (MI), a plaque ruptures and subsequent occlusion leads to a death of the heart muscle. The tissue is rapidly replaced with a scar, which may later lead to heart failure (HF). Optimally, disease biomarkers are analyzed from blood, provide insight into the disease progression and aid the evaluation of therapy efficacy. Unfortunately, no optimal biomarkers have been identified for IHD. The vast but uncounted number of patients with undiagnosed IHD, benefitting from an early diagnosis, underscore the dire need for an IHD biomarker. Epitranscriptomics, the study of posttranscriptional modifications on RNA, has recently been properly re-established. This expanding field is uncovering a new layer of regulation, controlling processes ranging from cell division to cell death. Over 170 modifications have been identified as posttranscriptional marks in RNA species. These modifications influence RNA metabolism, including export, stability, and translation. One the most common and intensively studied RNA modification is the N6-methyladenosine (m6A), the abundance and effects of which are determined by the interplay between its writers, readers and erasers. Recent findings suggest a local dysregulation of the m6A dynamics in the myocardium, coalescing in signalling pathway and contractility related RNA transcripts during hypertrophy, MI and HF. While these early reports have focused on the myocardium, the role of the m6A in the circulation during IHD remains unexplored. We hypothesize the IHD pathophysiology to be reflected in the epitranscriptome of the circulating RNA. The objective of the IHD-EPITRAN is to identify new IHD biomarkers via cohort comparison of the blood epitranscriptomes from patients with: (1) MI related with coronary angioplasty, (2) IHD treated with elective coronary artery bypass grafting, (3) aortic valve stenosis treated with valve replacement and (4) IHD-healthy controls verified with computerized tomography imaging. The RNA fractionation is followed by the quantitative modifications analysis with mass spectrometry. Ultimately, nanopore RNA sequencing with simultaneous m6A identification in their native sequences is carried out using recently published artificial intelligence-based algorithm.

NCT ID: NCT04525937 Recruiting - Clinical trials for Aortic Valve Stenosis

Racial and Economic Disparities and Unmet Needs in Patients With Severe Aortic Valvular Disease

Start date: June 4, 2018
Phase:
Study type: Observational

Common barriers to receiving appropriate guideline-driven care for patients with severe aortic stenosis include referral biases by primary care providers (lack of provider education), patient comorbidities (degree of fragility), as well as psychosocial issues and cultural barriers. Additionally, race, ethnicity, socioeconomic status (SES) and education level are shown to be persistent barriers to accessing healthcare services and healthcare systems, creating a significant practice gap between various patient populations. The most recent transcatheter valve therapies (TVT) registry data show that >94% of TAVR recipients are Caucasian, followed by less than 4% of African-Americans and Hispanics, respectively. There is a critical need to understand the barriers to treatment and care among severe aortic valve disease patients of disparate groups. This study is a multi-center, retrospective and prospective cohort study of patients diagnosed with severe aortic stenosis. Additionally, we will be surveying referring primary care providers, cardiologists and cardiovascular surgeons to assess their current referral practices for patients with severe aortic stenosis.

NCT ID: NCT04473443 Recruiting - Clinical trials for Aortic Valve Stenosis

Addition of Computer Simulations to Minimize Adverse Events After Transcatheter Aortic Valve Implantation

PRECISE_TAVI
Start date: August 1, 2020
Phase:
Study type: Observational

The objective is to assess the influence of FEops HEARTguide on overall device success in TAVI patients with challenging anatomies (Cohort A) or in transcatheter heart valve (THV) platform selection (Cohort B).

NCT ID: NCT04466787 Recruiting - Clinical trials for Supra-Aortic Stenosis

Comparison of Spectral Photon Counting CT (SPCCT) With Dual Energy CT (DECT) and Magnetic Resonance Imaging (MRI) for Plaque and Lumen Carotid Arteries Evaluation

CAPL
Start date: June 20, 2019
Phase: N/A
Study type: Interventional

In this study, the investigator propose to determine the efficiency of a new and more sophisticated imaging prototype, the Spectral Photon Counting Computed Tomography (SPCCT), at characterizing vulnerable plaques and luminal stenosis in Carotid Atherosclerosis patients compared to DECT (Dual Energy CT) and MRI (Magnetic Resonance Imaging) which are used in current practice

NCT ID: NCT04464655 Recruiting - Clinical trials for Coronary Artery Disease

A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease

Start date: December 12, 2019
Phase:
Study type: Observational

This study aims to identify and assess new CMR techniques that can improve current CMR protocols.

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: NCT04429035 Recruiting - Clinical trials for Aortic Valve Stenosis

SLOW-Slower Progress of caLcificatiOn With Vitamin K2

Start date: September 23, 2019
Phase: N/A
Study type: Interventional

A randomized 12-month trial will include two groups of 100 individuals aged over 50 years, with asymptomatic mild to moderate Aortic valve stenosis (AVA > 1 cm2, Vmax < 4 m/s). The first group of 100 individuals will serve as the intervention group that will receive 300 mcg of K2 vitamin on a daily basis, while the second group of 100 individuals will be the control group that will receive placebo on a daily basis as well. Both groups will be monitored identically in order to investigate therapeutic effects on calcification and valve stenosis progression. Correlation with Mitral annulus and ascending Aorta.Exclusion criteria: Chronic Kidney disease, Vitamin K antagonists, statins, age < 50 y.o,prosthetic valves,Aortic Valve area (AVA) < 1cm2 ,Vmax > 4 m/s