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Valvular Heart Disease clinical trials

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NCT ID: NCT05654272 Recruiting - Heart Failure Clinical Trials

Development of CIRC Technologies

CIRC
Start date: September 9, 2022
Phase:
Study type: Observational [Patient Registry]

Cardiovascular disease is the leading cause of death worldwide. Advanced cardiovascular imaging using Magnetic Resonance Imaging (MRI) has proven to be effective in providing gold standard myocardial tissue characterization. Moreover, the intrinsic advantage of MRI's lack of exposure to ionizing radiation is particularly beneficial. At the same time, blood work can be very useful in early detection of certain cardiomyopathy, such as amyloid. However, there is a lack of agreement of on which markers are the most sensitive. This multi-study will allow us the unique opportunity to form a more comprehensive understanding for various cardiovascular diseases. Our team has developed novel cardiac MRI techniques that leverages endogenous tissue properties to reveal a milieu of deep tissue phenotypes including myocardial inflammation, fibrosis, metabolism, and microstructural defects. Among these phenotypes, myocardial microstructure has proven to be most sensitive to early myocardial tissue damage and is predictive of myocardial regeneration. In this study, the investigators aim to further study the importance of cardiac microstructure revealed by MRI in patient and healthy population and compare this novel technology with conventional clinical biomarkers.

NCT ID: NCT05573997 Recruiting - Heart Failure Clinical Trials

Novel Echocardiographic Biomarkers Assessing the Myocardial Work in Heart Failure

Beyond-MyoHF
Start date: April 10, 2022
Phase:
Study type: Observational [Patient Registry]

This study seeks to investigate the clinical value of novel echocardiographic indices, including myocardial work parameters, during the acute phase of heart failure hospitalization. The trajectory of novel echocardiographic indices from the start to the end of hospitalization will be captured, as a means to unravel and subsequently better understand the diverse pathophysiology of different phenotypes of the heart failure continuum. Correlation between novel echocardiographic indices with clinical data, biochemical data, different heart failure phenotypes, and therapeutic maneuvers will be attempted. Prognostic implications of those indices will be explored.

NCT ID: NCT05455541 Recruiting - Clinical trials for Cardiovascular Diseases

Reliability of Artificial Intelligence (AI)-Augmented Point-of-care Cardiac Ultrasound in the Hands of Internists

Start date: August 21, 2022
Phase:
Study type: Observational

The study aim is to test the diagnostic performance of internists interpreting echo images aided by the AISAP CARDIO V0.7 diagnostic support system. Ground truth will be established by an interpretation by cardiologists specialized in echo, of the same POCUS images (acquired by the internist \ sonographer ). Up to 1000 subjects; Study population will be distributed according to the following schema: Group 1 -up to 800 patients hospitalized in the Internal Medicine division Group 2 - up to 200 patients hospitalized in the acute Geriatric division

NCT ID: NCT05453526 Recruiting - Clinical trials for Valvular Heart Disease

The Bronx-Valve Registry

Start date: April 1, 2022
Phase:
Study type: Observational

The Bronx-Valve Registry is designed to collect and assess data on all patients with valvular diseases referred to Montefiore Medical Center for echocardiographic exams.

NCT ID: NCT05417464 Recruiting - Clinical trials for Valvular Heart Disease

Evaluation and Validation of Management Strategy for Conductive Disorders After TAVR (EVATAVI)

EVATAVI
Start date: February 21, 2023
Phase: N/A
Study type: Interventional

Considering decrease of major complications and improvement of procedural results, conductive disorders currently remain the main issue after TAVR (Transcatheter aortic valve replacement). While pacemaker implantation rate was about 10-15%, new onset LBBB (Left bundle branch block) was observed in 30 % of patients after TAVR but resolved at discharge in the majority of them, with less than 20% progressed to complete AV (atrioventricular) block requiring permanent pacing at hospital discharge. Higher implantation and improvement of the devices were associated with decline of pace maker implantation rate over the years in experienced teams. While guidelines do not give definite recommendation regarding conductive disorder management and pacemaker indication, a strategy of selective telemetry monitoring (TM) after TAVR according to the risk of conductive disorders may be proposed to limit indication and lenght of stay of intensive care unit admission (ICU), allowing direct admission of lower risk patients in general cardiology ward (GCW) without TM, to decrease the duration of TM when a conductive disorder is stable or regressive and finally to decrease the rate of pacemakers implantation. Potential benefit may also include limitation of ICU overload in high volume TAVR centers, investigators can also expect shorter hospitalization duration, with potential economic impact, in line with the development of algorithms for fast track procedures. Therefore the main objective of our prospective study was to evaluate feasibility and safety of a strategy of management of conductive disorders after TAVR based on an algorithm of diagnosis, monitoring and therapeutic strategies based on ECG analysis.

NCT ID: NCT05357404 Recruiting - Clinical trials for Valvular Heart Disease

Age and Sex-Specific PREValence of AcqUirEd VALVular Heart DiseasE

PREVUE-VALVE
Start date: April 21, 2022
Phase:
Study type: Observational

The PREVUE-VALVE study will establish reliable, population-based estimates of Valvular Heart Disease (VHD) prevalence among older Americans and allow for the development and validation of several innovative tools to aid in the detection and diagnosis of Valvular Heart Disease (VHD).

NCT ID: NCT05330468 Recruiting - Clinical trials for Aortic Valve Disease

Regent China Post-Market Clinical Follow-up Study

Start date: March 29, 2022
Phase:
Study type: Observational

Regent China Post-Market Clinical Follow-Up (RC-PMCF): this clinical study is to confirm the safety and performance of Abbott's Regent MHV for replacement of native or prosthetic aortic valves in a Chinese population.

NCT ID: NCT05179278 Recruiting - Clinical trials for Valvular Heart Disease

Impact of a PROgram of Cardiovascular Nurse interventionS in a VALVular haEmodynamic Unit (PROCESS-VALVE) on Quality Indicators: a Quasi-experimental Ambispective Study

Start date: February 25, 2021
Phase: N/A
Study type: Interventional

The objective of this study is to evaluate the impact of a program of presurgical and postsurgical nurse interventions (PROCESS-VALVE) on quality indicators of the health of patients undergoing percutaneous valve procedures. (waiting times, patient satisfaction, admission times, hospital readmission, mortality, intrahospital complications and nosocomial infections). Design of the study is an ambispective quasi-experimental study. For the control group, data will be collected retrospectively from patients undergoing percutaneous valve procedures who did not receive pre- or postsurgical consultations. The intervention group will comprise those patients who agree to participate in the study and the haemodynamic nurse valve consultation program (PROCESS-VALVE). In addition, the investigators will assess whether a face-to-face postsurgical consultation improved quality indicators compared to postsurgical telephone consultation; for this, a sub-study will be carried out comparing face-to-face or telephone postsurgical follow-up by means of a randomised controlled clinical trial with simple blinding in the intervention group. Study area will be at the Hemodynamic Unit of the Hospital de la Santa Creu i Sant Pau and the study population are chosen patients for percutaneous valvular intervention who attend the pre-surgical consultation at our center. Dependent variable will be the indicators cited in the study aim and the independent variable will be the pre-surgical and post-surgical consultation. In pre-surgical consultation will be done a patient recruitment and will collect sociodemographic and clinical data. At patient will be done an individualized interview with an Ad-Hoc questionnaire and to collect fragility level of study and level of planned connections. In the subsequent follow-up, all pacients will receive a follow-up visit and collect satisfaction and quality indicators. But this pacients will be randomized to telephone follow-up or face-to-face follow up. Sample size has been calculated in 194 to be distributed equally in both groups and the clinical trials groups will be formed by 94 patients in each group The protocol has been modified to an ambispective quasi-experimental study with a subsequent randomization for the type of follow-up (telephone vs face-to-face) due to organizational changes in the participant center.

NCT ID: NCT05081115 Recruiting - Clinical trials for Coronary Artery Disease

Stress Echo 2030: the Novel ABCDE-(FGLPR) Protocol to Define the Future of Imaging

SE2030
Start date: April 1, 2021
Phase:
Study type: Observational [Patient Registry]

With stress echo (SE) 2020 study, a new standard of practice in stress imaging was developed and disseminated: the ABCDE protocol for functional testing within and beyond CAD. ABCDE protocol was the fruit of SE 2020, and is the seed of SE 2030, which is articulated in 12 projects: 1-SE in coronary artery disease (SECAD); 2- SE in diastolic heart failure (SEDIA); 3-SE in hypertrophic cardiomyopathy (SEHCA); 4- SE post-chest radiotherapy and chemotherapy (SERA); 5- Artificial intelligence SE evaluation (AI-SEE); 6- Environmental stress echocardiography and air pollution (ESTER); 7- SE in repaired Tetralogy of Fallot (SETOF) ; 8- SE in post-COVID-19 (SECOV); 9: Recovery by stress echo of conventionally unfit donor good hearts (RESURGE); 10- SE for mitral ischemic regurgitation (SEMIR); 11- SE in valvular heart disease (SEVA); 12- SE for coronary vasospasm (SESPASM). The study aims to recruit in the next 5 years (2021-2025) ≥10 000 patients followed for ≥5 years (up to 2030) from ≥20 quality-controlled laboratories from ≥10 countries. In this COVID-19 era of sustainable health care delivery, SE2030 will provide the evidence to finally recommend SE as the optimal and versatile imaging modality for functional testing anywhere, any time and in any patient.

NCT ID: NCT05078619 Recruiting - Clinical trials for Coronary Artery Disease

Percutaneous Coronary Intervention Before Transcatheter Aortic Valve Implantation

PRO-TAVI
Start date: October 5, 2021
Phase: N/A
Study type: Interventional

The aim of this trial is to evaluate the safety and cost effectiveness of omission of percutaneous coronary intervention of significant coronary artery disease in patients scheduled to undergo transcatheter aortic valve implantation.