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Mitral Valve Insufficiency clinical trials

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NCT ID: NCT05742789 Completed - Cardiac Disease Clinical Trials

Effect of Anesthetics on Troponin I and С-reactive Protein

Start date: November 30, 2021
Phase: Phase 1
Study type: Interventional

Abstract Troponin is one of the cardiac biomarkers and its high level correlates to high risk of cardiac myocytes damage. C-reactive protein (CRP) in cardiosurgery participates in the Systemic Inflammation Response Syndrome, and heart-lung apparatus is a powerful stimulator of the systemic inflammatory reaction. Objective: To assess effect of anesthetics on troponin I and СRP in mitral, tricuspid and aortic valve replacement/plastic in adult. Methods. Single-center prospective randomized controlled clinical study. A total of 95 patients were assigned randomly into three groups according to the type of anesthesia: the first group of 32 patients with propofol, the second group with sevoflurane - 32 patients, and the last - 31 patients were with isoflurane. Levels of the cardiac troponin I were calculated in ng/ml с using a portable fluorometric analyzer I-CHROMAII, manufacture of BoditechMedInc (South Korea). Normal range: <0.04 ng/ml. CRP concentration in plasma has been determined using a biochemical analyzer Biosystems BA-200 (Spanish company, Barcelona) according to the manufacturer's instructions. The normal level of CRP is less than 5 mg/l.

NCT ID: NCT05733988 Completed - Clinical trials for Mitral Regurgitation

Edge-To-Edge Technique Used as a Bailout in Case of Sub-Optimal Mitral Repair: Very Long-Term Results

Start date: July 10, 2021
Phase:
Study type: Observational

The absence of residual mitral regurgitation (MR) after mitral valve repair is of paramount importance for the long term durability of the valve repair. Thus, ideally, after weaning from cardio-pulmonary by-pass (CPB) the trans-esophageal echocardiogram (TEE) should show no (or only trivial) residual MR, good coaptation length and no iatrogenic mitral valve stenosis. However, mild or more residual MR can be present in up to 4% of the patients after the initial mitral valve repair and a second CPB run may be necessary to improve the repair results. Mechanism of residual MR can be dynamic, related to systolic anterior motion (SAM) or to severe left ventricular dysfunction, and anatomical, related to residual prolapse, cleft, and suture or ring dehiscence. In several cases medical therapy can be effective in the management of the intra-operatively detected SAM, and residual cleft or suture dehiscence can be easily corrected during a second CPB run. However, in other cases SAM is not responsive to medical therapy or the residual MR jet would require complex and time-consuming techniques to be addressed, or even worse scenario, a mitral valve replacement could be necessary. In such cases the edge-to-edge (EE) technique can be used as a bail-out procedure. The anatomical characteristics of the mitral valve after an initial sub-optimal repair are certainly not ideal for the edge-to-edge technique, due to a possible significant reduction in the valve area, especially in case of posterior leaflet resection or small ring implanted. Nevertheless, in the short term the edge-to-edge technique used to rescue patients with sub-optimal initial repair resulted effective. However, the very long-term results of the edge-to-edge technique used as bail-out are not known. Thus, the aim of this study is to evaluate the clinical and echocardiographic results of the edge-to-edge technique used to rescue patients with initial sub-optimal mitral repair.

NCT ID: NCT05724537 Completed - Clinical trials for Mitral Valve Disease

Durability at 20 Years of Quadrangular Resection With Annular Plication for Mitral Regurgitation

Start date: February 23, 2019
Phase:
Study type: Observational

Degenerative mitral regurgitation (MR) due to prolapse of the posterior leaflet is the most common dysfunction of the mitral valve (MV) in the Western world and is nowadays treated with a variety of surgical techniques. Quadrangular resection combined with annular plication and annuloplasty, as originally described by Carpentier, has been the standard approach for many years, before sliding/folding plasty and artificial chordae gained larger popularity.However, very few studies have been published on thevery long-term results (up to 20 years) of quadrangular resection and annular plication, often reporting only freedom from reoperation rather than from recurrent MR. This study aims to evaluate the very long-term (20 years) clinical and echocardiographic results of this approach, which was used for many years at the beginning of our mitral repair program.

NCT ID: NCT05714228 Completed - Clinical trials for Mitral Valve Regurgitation

Validation of the EuroSCORE II in Open and Trans-catheter Mitral Valve Repair.

Start date: June 10, 2020
Phase:
Study type: Observational

The EuroSCORE II is widely used to predict 30-day mortality in patients undergoing open and trans-catheter cardiac surgery - However, it has not been validated in patients undergoing surgical or trans- catheter mitral valve repair. - The aim of this study is to evaluate the predictive value of the EuroSCORE II in estimating 30-day mortality in a large cohort of patients undergoing surgical and trans-catheter repair by means of Mitraclip implantation. Methods - Institutional database retrospective review for surgical mitral repair and MitraClip implantation. - Time frame: January 2012-December 2019 - 2793 patients identified; Euroscore II 1.3% [0.6%-2%] - Survival after hospital discharge was assessed by outpatients visit, usually done 2 months after the index procedure. Statistical analysis - Receiver operating characteristic (ROC) curves were used to determine the cut-offs of Euroscore II. ROC Area Under the Curve (AUC) values varies between 0 and 1, where 0.5 denotes a bad diagnostic test and 1 denotes an excellent diagnostic test. - The maximum Youden's Index (J=sensitivity + specificity - 1) was employed to define the optimal cut-point. - ROC curves were repeated for surgical and MitraClip patients separately, and for primary and secondary etiology as well.

NCT ID: NCT05696509 Completed - Clinical trials for Mitral Valve Insufficiency

Influence of Anesthetics on Clinical Outcome in Mitral and Aortic Valve Replacement in Adults

Start date: January 3, 2020
Phase: Phase 3
Study type: Interventional

Abstract Anaesthetic support for cardiac surgery significantly influences the course of the intraoperative period and the success of the postoperative period. Total intravenous anaesthesia and inhalation anaesthesia are the traditional methods of anaesthesia in cardiac surgery. However, there are few studies assessing the effectiveness of surgical aggression protection in cardiac surgery. Objectives: To study the effect of anesthetics on clinical outcome after mitral and aortic valve replacement in adults. Methods. The data of 75 patients operated in the Cardiosurgery Department of the Medical Center Hospital of the Presidential Administration of the Republic of Kazakhstan were included in the study. All patients underwent mitral, aortic valve replacement/plasty under cardiopulmonary bypass (CPB) conditions. All patients were divided into 3 groups according to the type of anaesthesia: the first (1) group patients anaesthetised with propofol (P), the second group with sevoflurane (S), and the last one is with isoflurane (I). To maintain anaesthesia in Group 1 propofol was used as anaesthetic in a dose of 6 mg/kg/h intravenously on perfusion. In Group 2 the anaesthetic used was sevoflurane in a dose of 1.7-1.9 MAC. Group 3 used isoflurane in the dose of 1.1-1.2 MAC as anaesthetic. Statistical analysis was done by the method of single factor analysis of variance and Kruskal Wallis criterion.

NCT ID: NCT05695287 Completed - Clinical trials for Coronary Artery Disease

The Effects of Sevoflurane, Isoflurane and Propofol During Cardiac Surgery

Start date: January 22, 2021
Phase: Phase 1
Study type: Interventional

Abstract Anaesthetic support for cardiac surgery significantly influences the course of the intraoperative period and the success of the postoperative period. Total intravenous anaesthesia and inhalation anaesthesia are the traditional methods of anaesthesia in cardiac surgery. However, there are few studies assessing the effectiveness of surgical aggression protection in cardiac surgery. Objectives: To study the effectiveness of body protection against surgical aggression by TIVA and inhalational anaesthesia in cardiac surgery. Materials and methods. The examination and treatment data of 89 patients were included in the study. All patients underwent coronary artery bypass grafting, mitral valve replacement/plasty, aortic valve replacement cardiopulmonary bypass conditions. The patients were divided into 2 groups according to the type of disease: the first (1) group with coronary heart disease. The second (2) group with valvular heart disease. There were 65 patients in the first group and 22 in the second. Both groups were divided into 3 subgroups according to the type of anaesthesia: patients anaesthetised with propofol, with sevoflurane, with isoflurane.

NCT ID: NCT05475561 Completed - Clinical trials for Mitral Regurgitation

Comparison of Erector Spinae Block and Pecto-Intercostal Facial Block For Enhanced Recovery in Adult Cardiac Surgery

Start date: May 25, 2022
Phase: Phase 2
Study type: Interventional

The current study is designed to compare the perioperative analgesic efficacy of Erector spinae plane block (ESPB) and Pecto-intercostal-fascial plane block (PIFB) in adults undergoing cardiac surgery via median sternotomy. The primary outcome measure will be the analgesic effectiveness of both blocks in median sternotomy pain, while the secondary outcome measures will be time to extubation, and length of intensive care unit stay.

NCT ID: NCT05117359 Completed - Clinical trials for Cardiac Valve Disease

Transcatheter Para-Valvular Leak Closures

FFPP1
Start date: January 1, 2017
Phase:
Study type: Observational

Despite improvements in available techniques and prostheses, the long-term evolution of patients after transcatheter paravalvular leak closure remains poorly understood. The objective of this study is to evaluate the long-term outcome of patients after transcatheter paravalvular leak closure and to identify factors predictive of survival. The investigators designed a retrospective multicentre observational registry entitled FFPP (e.g. "Fermeture des Fuites Para-Prothétiques" in French). Seventeen centres from France, Poland, Turkey and Belgium enrolled retrospectively at least one PVLc procedure on aortic, mitral, tricuspid or pulmonary valves without limit in its delay of performance.Follow-up of at least one year was expected

NCT ID: NCT04527367 Completed - Clinical trials for Coronary Artery Disease

Epidemiology and Long-term Outcome of Patients With VHD

BIA-WAD
Start date: January 2006
Phase:
Study type: Observational

Valvular heart diseases are significant problem in Polish population. Coexistence of coronary artery disease in patients with VHD increases the risk of death and affects further therapeutic strategy. The aim of the study is analysis the epidemiology and the long-term prognosis among patients with VHD.

NCT ID: NCT04473092 Completed - Clinical trials for Mitral Regurgitation

Prospective Analysis of the Feasibility of the PASCAL Spacer Technology for Transcatheter Mitral Valve Repair in an All-comers Cohort

OneForAll
Start date: July 20, 2020
Phase:
Study type: Observational

To identify changes on mitral valve morphology and functionality by the application of the PascalTM in MR.