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Mitral Valve Disease clinical trials

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NCT ID: NCT06235385 Recruiting - Clinical trials for Aortic Valve Stenosis

European Association of Cardiovascular Imaging Multiple and Mixed Valvular Disease Study

EACVI-MMVD
Start date: February 7, 2024
Phase:
Study type: Observational

This study aims to investigate the prevalence and characteristics of multiple and mixed valvular heart disease (MMVD), which includes combinations of stenotic or regurgitant lesions on cardiac valves. The research will be conducted as a multicenter observational study, involving several centers worldwide, and will have a one-year follow-up period (with a possible extension to 5 years). The primary aim is to determine the proportion of MMVD among patients evaluated for valvular heart disease. Secondary aims include the evaluation of the epidemiologic distribution of clinical, biological, and cardiovascular imaging characteristics at baseline, management strategies, and their impact on prognosis. The study will also evaluate clinical outcomes such as mortality, hospitalization for heart failure, and changes in echocardiographic parameters. This research aims to provide valuable insights into the diagnosis, management, and prognosis of MMVD, addressing an important knowledge gap in this area.

NCT ID: NCT06197321 Recruiting - Clinical trials for Coronary Artery Disease

Non-invasive Prediction of Fluid and Noradrenaline Responsiveness Using the Carotid Wave Intensity.

VACC
Start date: January 15, 2024
Phase:
Study type: Observational [Patient Registry]

The goal of this observational study is to study a new method to compute ventricular-arterial coupling (VAC) in adult intensive care patients after cardiac surgery. VAC is a metric that describes the interaction between the heart and the arterial system. The new method of measuring VAC uses carotid ultrasound measurements. The main questions this study aims to answer are: - Can VAC measured using carotid ultrasound predict the hemodynamic response to drugs? - What is the concordance of VAC measurements obtained via carotid ultrasound with VAC measurements obtained via the standard, single-beat method? Measurements will be performed in the operating room and at the ICU.

NCT ID: NCT06153563 Recruiting - Clinical trials for Mitral Valve Disease

Evaluation of the Elasticity of the Mitral Valve

Start date: October 18, 2021
Phase:
Study type: Observational

There is no information in the literature on the mechanobiological characteristics of mitral valve chords in living humans. All examinations were carried out on tissues taken from animals, either from cadavers or from frozen human tissues. The objective is to determine mechanobiological and histological characteristics of the mitral valve chords in living humans, as well as to compare differences in elasticity in different groups (Group A: patients with mitral valve prolapse versus Group B: patients with restrictive ischemic mitral valve).

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: 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: 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.

NCT ID: NCT05898230 Recruiting - Clinical trials for Mitral Valve Disease

Retrospective Clinical Data Collection on Carbomedics OptiForm Mitral Heart Valve

Start date: November 23, 2023
Phase:
Study type: Observational

The objective of this study is to evaluate the medium- to long-term safety of the Carbomedics OptiForm Mitral Heart Valve after the implantation for mitral valve disease in the Chinese population. The study is designed as a post-market, retrospective, single arm and multicentric data collection

NCT ID: NCT05892588 Recruiting - Clinical trials for Aortic Valve Stenosis

Prevalence Study of Cardiovascular Diseases in a Population ≥ 65 Years in Italy

PREVASC
Start date: June 1, 2022
Phase:
Study type: Observational [Patient Registry]

This registry is a large-scale epidemiological study (PREVASC) aimed at estimating the prevalence of symptomatic and asymptomatic valvular hear disease in men and women aged over 65 years randomly selected in Italy.

NCT ID: NCT05736289 Recruiting - Clinical trials for Mitral Regurgitation

Evaluation of Mitral Valve Insufficiency Under General Anesthesia

MITIGATE
Start date: February 13, 2023
Phase:
Study type: Observational

Observational study in adult humans undergoing surgical or cardiological intervention for mitral valve insufficiency. Investigators aim to evaluate hemodynamic changes on an arterial pressure waveform level in patients before and after mitral valve intervention using Nexfin (BMEYE, Amsterdam, the Netherlands) continuous non-invasive hemodynamic monitoring, using finger cuff based technology to register beat-to-beat data

NCT ID: NCT05531253 Recruiting - Cardiac Disease Clinical Trials

Respired Gases in Patients Post Cardiac Surgery

REGAPS
Start date: October 30, 2022
Phase:
Study type: Observational

Certain diseases relating to the heart can only be definitively treated with surgery. When untreated, these can lead to heart failure with a lack of supply of oxygen-rich blood to the tissues, leading to damage to other organs. Adults who undergo heart surgery vary greatly in terms of age and relative health. This has significant implications when predicting outcomes in the aftermath of surgery. For example, a 90-year-old man with a variety of comorbidities such as diabetes and high cholesterol who requires a heart valve replacement may have an unfavourable chance of surviving the postoperative period when compared to an 18-year-old woman with no significant medical history undergoing the same procedure. Almost invariably, patients are admitted to an Intensive Care Unit (ICU) following heart surgery. This is done to facilitate close monitoring of the patients' vital organ functions and to also provide organ support if needed. For the heart, this can include the administration of drugs to help a heart pump forcibly, cause blood vessels to contract and increase blood pressure. Patients who have undergone heart surgery have been placed on a mechanical ventilator, following a tube placed in their windpipe. This form of ventilation often continues in ICU for a period of time, depending on the patient's condition. One specific type of ICU level monitoring that occurs in patients who have undergone heart surgery is cardiac output monitoring. This involves a thin tube, called a pulmonary artery catheter, that extends from the skin to the heart, via large blood vessels. Cardiac output monitoring is essential in this patient group to guide organ support and to provide information of how well the heart is functioning. In this observational study, the investigators wish to study patients who have undergone cardiac surgery, are receiving mechanical ventilation and have pulmonary artery catheters inserted. The investigators will collect cardiopulmonary data in these patients and compare these data with values of exhaled and inhaled gases (oxygen and carbon dioxide) over the same time period. This will enable the investigators to investigate the link between cardiopulmonary data and respired gas values. A better understanding of this link between cardiopulmonary function and oxygen/carbon dioxide values will then inform future studies aiming to determine the effect of various interventions in similar patient groups.