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Heart Valve Diseases clinical trials

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NCT ID: NCT06247358 Recruiting - Physical Disability Clinical Trials

Frailty, Physical Capacity and Lung Function in Postoperative Cardiac Surgery Patients

Start date: February 16, 2024
Phase:
Study type: Observational

The goal of this observational and prospective study is to investigate changes in physical performance, lung function, and respiratory and peripheral muscle strength in patients during the postoperative period following coronary artery bypass grafting (CABG) and valve replacement surgery..

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: NCT06223906 Recruiting - Clinical trials for Cardiovascular Diseases

A Registry Study of Biomarkers in Heart Valve Disease

BIOMS-HVD
Start date: January 1, 2016
Phase:
Study type: Observational

Valvular Heart Disease, impacting 2.5% of the population, is predominantly observed in the elderly and is on the rise. The primary conditions within this category are Aortic Stenosis and Mitral Regurgitation. These conditions are linked to considerable morbidity and mortality, presenting a formidable challenge in optimizing treatment strategies. Pathophysiology of Valvular Heart Disease remains poorly known. The aim of the present study is to identify biomarkers involved in this disease using multi-omics approaches

NCT ID: NCT06204783 Recruiting - Heart Failure Clinical Trials

Real-time Pressure Volume Loop Monitoring as a Guide for Enhanced Understanding of Changes in Elemental Cardiovascular Physiology During Therapeutic Strategies Aiming for Hemodynamic Optimization. Cohort II: Structural Heart Interventions (PLUTO-II)

PLUTO-II
Start date: November 14, 2022
Phase:
Study type: Observational

The aim of PLUTO-II is to use biventricular pressure-volume (PV) loop measurements to improve the understanding of direct changes in cardiac and hemodynamic physiology induced by transcatheter aortic valve implantation (TAVI) or tricuspid edge-to-edge repair (TEER). These procedures evoke immediate changes in cardiac mechanoenergetics, ventricular-vascular interaction as well as ventricular (in)dependency. Within the context of PLUTO-II, patients will undergo biventricular PV-loop measurements before and after TAVI or TEER. In future, the application of perprocedural PV loop monitoring may tailor the daily individual decision making process during structural interventions in the catheterization laboratory.

NCT ID: NCT06154473 Recruiting - Cardiac Disease Clinical Trials

Assessment of Patients Undergoing Cardiac Surgery and Admitted to the Intensive Care Unit

BraSIS-2
Start date: September 1, 2023
Phase:
Study type: Observational

The objective of this study is to investigate the incidence of death and early postoperative complications, identify potential risk factors, and examine the demographic characteristics of patients and epidemiology of cardiovascular procedures. Our hypothesis is that gaining a more comprehensive understanding of the characteristics of patients who undergo cardiac surgery has the potential to improve outcomes for this patient profile. Thus, information was sought regarding the patient characteristics, surgeries performed, anesthesia administered, incidence of intraoperative and postoperative complications, and risk factors associated with complication and mortality in the ICU. The main questions it aims to answer are: - Incidence of mortality or severe postoperative complications that occur within the first 3 postoperative days or until discharge from the ICU. - Risk factors associated with severe complications in patients who undergo cardiac surgery. - Characteristics of patients, anesthesia and surgical procedures performed - Incidence of severe intraoperative complications and moderate postoperative complications - Evaluate the influence of accumulated fluid balance on outcomes, mortality, and length of ICU stay. - Evaluate mortality in the ICU. - Describe the risk factors associated with mortality.

NCT ID: NCT06153407 Recruiting - Clinical trials for Bicuspid Aortic Valve

Genetic Test Based Risk Prediction of Early Calcific Aortic Valve Disease in Patients With Bicuspid Aortic Valve

Start date: October 19, 2023
Phase:
Study type: Observational

This study is to elucidate the impact of germline mutations and clonal hematopoiesis (CHIP) on the progression of early aortic valve calcification in patients with bicuspid aortic valves. The study will be conducted over a recruitment period of one year and a follow-up observation period of two years. Considering a 2-year event rate and a 33% occurrence rate of clonal hematopoiesis, each group requires a minimum of 102 participants. Accounting for a 15% dropout rate, a total of 120 participants are needed for each group (type I error (α) = 5%, type II error (β) = 20%). Therefore, the total study population, including patients with normal aortic valve function, is set at 240 participants.

NCT ID: NCT06126367 Recruiting - Atherosclerosis Clinical Trials

Assessment of Lipoprotein(a) and Endogenous Fibrinolysis in Atherosclerotic Cardiovascular Disease/Aortic Valve Disease

ALFA
Start date: October 20, 2023
Phase:
Study type: Observational

Prior studies have shown that impaired endogenous fibrinolysis is a novel, independent cardiovascular risk factor in patients with myocardial infarction and there is currently no known chronic treatment to enhance endogenous fibrinolysis. To date, no therapies have been able to sufficiently reduce Lp(a) and therefore it was considered to be a non-modifiable cardiovascular risk factor. New data, however, has shown that PCSK9 inhibitors and inclisiran (medication that you have been deemed eligible for in order to help further reduce your cholesterol levels) to reduce Lp(a) levels by approximately 20-25%. The aim of this study to is to assess: 1. if there is an association between raised Lp(a) level in blood and the effectiveness of endogenous fibrinolysis (lysis time). 2. whether lowering Lp(a) with PCSK9i or inclisiran can enhance endogenous fibrinolysis

NCT ID: NCT06084091 Recruiting - Clinical trials for Coronary Artery Disease

Spectroscopic Assessment of Intramyocardial Oxygen Saturation During Open-Heart Surgery

ECS
Start date: October 6, 2023
Phase:
Study type: Observational

The goal of this observational study is to test in the safety and performance of intraoperative myocardial spectroscopic measurement in open-heart surgery patients The main questions it aims to answer are: - The Devices can record myocardial spectrometric data for analysis, and - How these measures correlate with the occurring events, procedures, and clinical parameters during the operation. - Number of participants with device-related adverse events as assessed by CTCAE v4.0

NCT ID: NCT06077721 Recruiting - Clinical trials for Ischemic Heart Disease

Milrinone on Right Ventricular Strain in Cardiac Surgery

Start date: November 3, 2023
Phase:
Study type: Observational

The purpose of this study is to analyze the changes in right ventricular strain before and after milrinone administration in order to find out whether milrinone improves RV systolic performance in patients undergoing cardiac surgery.

NCT ID: NCT06077201 Recruiting - Clinical trials for Valvular Heart Disease

Home-Based Cardiac Rehabilitation Using a Novel Mobile Health Exercise Regimen Following Transcatheter Heart Valve Interventions

HOMERUNHITTER
Start date: December 15, 2023
Phase: N/A
Study type: Interventional

The vast majority of cardiac rehabilitation eligible individuals do not participate in center based cardiac rehabilitation (CBCR). While steps to encourage participation in CBCR are important, many individuals will still not participate for a variety of reasons. This randomized controlled trial is evaluating a home-based cardiac rehabilitation (HBCR) intervention delivered using a custom app and digital tools in patients undergoing transcatheter heart valve interventions (THVIs). After a brief roll-in period, participants not intending to participate in CBCR are randomized to one of three groups: (1) control, (2) HBCR mobile health intervention with hands-off delivery, and (3) HBCR mobile health intervention with interactive delivery. Participants in the intervention groups (hands-off/interactive delivery) will also be randomized to continue the intervention for 12 weeks or 24 weeks. The intervention targets key health behaviors and includes traditional cardiac rehabilitation components. The study will assess the effect of the intervention on clinical events, physical activity, quality of life, and other outcomes. Those who intend to participate in CBCR will be followed in a registry.