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Aortic Valve Disease clinical trials

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NCT ID: NCT06069232 Recruiting - Clinical trials for Aortic Valve Disease

Aortic Valve Diseases RISk facTOr assessmenT and Prognosis modeL Construction

ARISTOTLE
Start date: March 1, 2021
Phase:
Study type: Observational

This study is a multicenter cohort study including patients diagnosed with aortic valve disease during hospitalization, including aortic insufficiency and aortic valve stenosis. The primary outcome of the study was all-cause death, and the secondary outcome was cardiovascular events. Through follow-up observation, the prognostic risk factors of patients with aortic disease were evaluated, and a prognostic model was constructed to guide clinical decision-making.

NCT ID: NCT06034028 Recruiting - Clinical trials for Aortic Valve Disease

J-Valve TF Early Feasibility Study

JVTF EFS
Start date: October 16, 2023
Phase: N/A
Study type: Interventional

The main objective of this study is to assess the preliminary safety and effectiveness of the J-Valve TF System in patients with symptomatic severe native aortic regurgitation who are judged by a multi-disciplinary heart team to be eligible for the device and to be at high risk for open surgical aortic valve replacement.

NCT ID: NCT06025149 Recruiting - Clinical trials for Aortic Valve Disease

The Study on the Use of "UniLine" Bioprosthesis in the Treatment of Isolated Aortic and Mitral Valve Diseases

Uniline
Start date: September 1, 2018
Phase:
Study type: Observational

The goal of this open, prospective, multicenter study is analyze long-term outcomes of aortic/mitral valve replacement using the "UniLine" bioprosthesis in patients with acquired aortic or mitral valve diseases. Main research objectives: To analyze long-term (up to 12 years) outcome of aortic or mitral valve replacement using the "UniLine" bioprosthesis. To study the hemodynamic characteristics of normally functioning "UniLine " prostheses in the mitral or aortic valve position based on the transthoracic echocardiography data. To assess the number, type, time frames of dysfunctions of UniLine bioprostheses and the results of their treatment. To analyze the frequency of major serious adverse events associated with the "UniLine" bioprosthesis or procedure.

NCT ID: NCT06011148 Not yet recruiting - Clinical trials for Aortic Valve Disease

Clinical Data Collection on Perceval S Sutureless Prosthetic Aortic Valve in the Chinese Population

Start date: December 2024
Phase:
Study type: Observational

The objective of the study is to evaluate the safety information on the Perceval S sutureless prosthetic heart valve after the implantation for aortic valve disease. The study is designed as a post-market, observational, non-interventional retrospective and prospective registry.

NCT ID: NCT06001489 Recruiting - Clinical trials for Aortic Valve Disease

The Effects of 360-degree Virtual Reality on Pre-procedural Anxiety in Patients Awaiting Elective Cardiac Surgery Involving a Sternotomy

Start date: September 2023
Phase: N/A
Study type: Interventional

Rationale: Patients awaiting cardiac surgery can experience pre-procedural anxiety. This anxiety is associated with increased analgesic needs, increased risk of mortality and prolonged recovery time. Adequate patient education can help diminish pre-procedural anxiety and minimize postoperative complications. Recent studies have demonstrated that Virtual Reality (VR) can function as a useful tool to diminish pre-procedural anxiety in several medical fields. Especially 360 degree VR could familiarize patients with their clinical pathway. Nevertheless, limited to no research on the application of 360 degree VR has been conducted in the context of cardiothoracic surgery yet. Objective: The aim of this study is to explore the effects and possible benefits of 360 degree VR on pre-procedural anxiety in patients awaiting elective cardiac surgery involving a sternotomy, compared to standard forms of patient education. Study design: Single-center, randomized controlled trial Study population: Patients aged 18 or older awaiting elective cardiac surgery involving a sternotomy.

NCT ID: NCT05998694 Recruiting - Clinical trials for Aortic Valve Disease

Post-market Clinical Monitoring of the Safety and Efficacy of the Aortic Valve Bioprothesis

TiAra
Start date: June 1, 2021
Phase:
Study type: Observational

The goal of this multicenter prospective cohort study is to evaluate the long-term safety and efficacy of clinical outcomes of aortic valve replacement using the "TiAra" prosthesis with or without concomitant procedures. Main research objectives: 1. To analyze the short and mid-term (up to 3 years) outcome of aortic valve replacement using the "TiAra" prosthesis. 2. To study the hemodynamic characteristics of normally functioning "TiAra" prostheses in the aortic position, as well as the condition of the heart chambers in short and long-term period (up to 10 years) after the implantation. 3. To assess complications of the early and mid-term follow-up periods of aortic valve replacement using the "TiAra" prosthesis. This study does not presuppose implementation of comparison groups.

NCT ID: NCT05979870 Enrolling by invitation - Clinical trials for Magnetic Resonance Imaging

Artificial Intelligence in New Cardiac MR Markers for Congenital Heart Disease

AI-CMR
Start date: October 1, 2022
Phase:
Study type: Observational

The goal of this study is to investigate children with aortic and pulmonary valve disease treated or untreated longitudinally. Established CMR measures with additional newly developped, promising, highly refined and clinically applicable quantitative imaging biomarkers, will be utilized as compared to the conventional CMR estimates. The main question[s] it aims to answer are: - [question 1]To evaluate risk stratification for surgery and intervention of the aortic- and pulmonary valve - [question 2]Investigate the cardiac and vascular hemodynamic and morphological changes before and after interventional or surgical treatment of the aortic- and pulmonary valve at short and long term. Participants will undergo cardiac MRI before and after interventional or surgical treatment of the aortic or pulmonary valve Researchers will compare MRI data to an age matched control group established at the department in another study.

NCT ID: NCT05977257 Not yet recruiting - Clinical trials for Aortic Valve Stenosis

VitaFlow® Transcatheter Aortic Valve Replacement System Pre-market Trial Long Term Follow Up (VITAL)

VITAL
Start date: July 30, 2023
Phase:
Study type: Observational

This study is an observational study to evaluate the long-term safety and effectiveness of the valve system.

NCT ID: NCT05975567 Not yet recruiting - Clinical trials for Coronary Artery Disease

Deploying Novel Imaging Modalities Towards a Three-dimensional (3D) CARDIOvascular PATHology

3D-CARDIOPATH
Start date: September 1, 2023
Phase:
Study type: Observational

The goal of the 3D-CARDIOPATH study is to investigate the potential added value of emerging 3D imaging modalities by imaging ex vivo cardiac specimens (diseased coronary arteries, calcific aortic valves, and thrombotic materials) in 3D. Specifically, 20 cadaveric coronary artery segments with advanced atherosclerosis will be received from 10 patients with SCD. These segments will first be scanned with intravascular imaging modalities, namely optical coherence tomography (OCT) and intravascular ultrasound (IVUS), and then with micro-computed tomography (micro-CT) and light sheet fluorescence microscopy (LSFM). Additionally, 30 thrombotic specimens aspirated from patients with ST-elevated myocardial infarction, will also be scanned using micro-CT. Finally, 30 surgically removed aortic valves will undergo scanning with micro-CT and LSFM. Traditional histopathological assessment will also be performed on the scanned specimens. Patient laboratory profiles, past medical histories, demographic characteristics, and therapeutic management will be recorded, where applicable.

NCT ID: NCT05961150 Recruiting - Clinical trials for Aortic Valve Disease

PROMISE: Percutaneous peRipheral cannulatiOn for Minimally-InvaSive Heart Valve surgEry

Start date: August 1, 2023
Phase:
Study type: Observational

In addition to conventional heart valve surgery (HVS) via full-sternotomy, which is still the most prevalent therapeutic strategy to address valvular heart disease (VHD), minimally-invasive approaches evolved as safe alternatives, resulting in lower postoperative ventilation times, transfusion rates and shorter in-hospital stay. Femoral artery cannulation is traditionally performed via surgical cutdown to establish cardiopulmonary bypass during minimally-invasive HVS. To avoid groin incision associated infection and lymphocele formation, and further minimize surgical trauma, the use of percutaneous cannulation including novel endovascular closure devices increases as an alternative but remains to be investigated. The Percutaneous peRipheral cannulatiOn for Minimally-InvaSive heart valve surgEry (PROMISE) registry aims to elucidate the safety, feasibility, and effectiveness of newly developed vascular closure devices during minimally-invasive HVS. Acute intra- and perioperative complications will be evaluated according to modified definitions of the Valve Academic Research Consortium (VARC)-3. In addition, based on the initial results, the comparison of percutaneous cannulation with conventional surgical cut-down techniques is planned.