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Mitral Valve Insufficiency clinical trials

View clinical trials related to Mitral Valve Insufficiency.

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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: 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: NCT05688514 Recruiting - Clinical trials for Mitral Valve Regurgitation (Degenerative or Functional)

TVMR With the Innovalve System Trial - First In Human Israel

TWIST-FIHIL
Start date: October 1, 2021
Phase: N/A
Study type: Interventional

Study to evaluate the safety and performance of the Innovalve mitral valve replacement system

NCT ID: NCT05682066 Recruiting - Clinical trials for Mitral Valve Regurgitation (Degenerative or Functional)

TVMR With the Innovalve System Trial - Pilot in Georgia

TWIST-PILOT-GE
Start date: December 1, 2021
Phase: N/A
Study type: Interventional

Study to evaluate the safety and performance of the Innovalve mitral valve replacement system

NCT ID: NCT05678868 Recruiting - Clinical trials for Mitral Regurgitation

Structural Mitral Valve Project

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

This is a prospective Quality Improvement (QI) study using the Model for Improvement framework. The objective of this study is to implement a structured, comprehensive, innovative, and sustainable approach to the management of patients with advanced mitral valve (MV) disease and heart failure (HF) in Southeastern Ontario and to improve healthcare delivery, patient care, and patient outcomes in the context of structural surgical and percutaneous MV interventions. This will be achieved through the strategic implementation, promotion, and evaluation of: i.The first local Southeastern Ontario Structural Mitral Valve Clinic using an Interdisciplinary heart team (IHT) at the Kingston Health Sciences Centre (KHSC) and its integration with the KHSC's existing Heart Failure Clinic; ii.The first provincial Structural Mitral Valve Clinic electronic referral service on the Ontario electronic services platform; and iii.The promotion of the above through targeted KT (Knowledge Transfer) outreach activities. Patients for this study will be recruited through medical referral within the south eastern Ontario, Canada region.

NCT ID: NCT05677568 Enrolling by invitation - Clinical trials for Mitral Regurgitation

The CINCH-FMR Post-Market Registry: Percutaneous Repair in Functional Mitral Regurgitation

CINCH-FMR
Start date: June 24, 2017
Phase:
Study type: Observational [Patient Registry]

This is a retrospective and prospective, multi-center, post-market observational registry study. The primary objective of this post market registry is to continue to evaluate the long term safety and performance of the Carillon® Mitral Contour System® (CMCS) in a commercial (post market) setting.