Clinical Trials Logo

Mitral Valve Insufficiency clinical trials

View clinical trials related to Mitral Valve Insufficiency.

Filter by:
  • Completed  
  • Page 1 ·  Next »

NCT ID: NCT05865938 Completed - Clinical trials for Mitral Regurgitation

PASCAL vs. MitralClip for Mitral Valve Transchatheter Edge-to-Edge Repair

Start date: June 1, 2019
Phase:
Study type: Observational

Comparsion of the current two available TEER systems, the MitraClip with the PASCAL repair system in terms of their effectiveness and safety in patients with degenerative mitral regurgitation (DMR) and in patients with functional regurgitation (FMR), who were referred for an interventional therapy by the heart team due to a high surgical risk profile.

NCT ID: NCT05850026 Completed - Clinical trials for Mitral Regurgitation

Mitral Regurgitation in Hypertrophic Obstructive Cardiomyopathy: Fix it in a Simple, Effective and Durable Way!

Start date: October 5, 2019
Phase:
Study type: Observational

Septal myectomy is performed in selected cases to treat patients with hypertrophic obstructive cardiomyopathy (HOCM). The mechanism that causes obstruction involves both the outflow tract itself and the mitral apparatus, with the appearance of mitral regurgitation (MR) by SAM (Systolic Anterior Motion). When the interventricular septum is not particularly thick, isolated myectomy may not be sufficient to eliminate the SAM; in these cases the concomitant treatment of the mitral valve is considered. Different approaches have been proposed: mitral replacement with prosthesis, plication or lengthening of the anterior leaflet or the edge-to-edge (EE) technique. In addition, a small proportion of patients with HOCM may have MR from organic valve abnormalities, requiring specific treatment. Currently, there are few studies in the literature aimed at determining the role of EE in the context of HOCM; most of these studies are characterized by short follow-up or by the scarcity of echocardiographic data. The aim of the present study is to evaluate the long-term outcomes of EE associated with septal myectomy in patients with CMIO, both from a clinical point of view and by reporting echocardiographic data.

NCT ID: NCT05836532 Completed - Clinical trials for Mitral Regurgitation

Long Term Results of Surgical and Percutaneous Double Orefices Mitral Repair in Patient With p2 Prolapse Causing Degenerative Mitral Regurgitation

Start date: October 5, 2019
Phase:
Study type: Observational

Mitral regurgitation is a pathology affecting the left atrioventricular valve that causes a volumetric and pressure overload in the left chambers due to the loss of unidirectionality normally guaranteed by the cardiac valve system. The gold standard for severe mitral regurgitation is currently mitral valve plastic surgery. Edge to edge, on the other hand, allows shorter CEC and aortic clamping times and does not require significant surgical experience in the field of mitral valve repair, therefore edge to edge could be an excellent strategy in patients suffering from mitral regurgitation caused by P2 prolapse when quadrangular resection cannot be performed. The main objective of the present study is to examine the medium to long-term outcomes (in terms of survival and plastic outcomes) of patients undergoing central edge-to-edge to treat posterior flap pathology (P2).

NCT ID: NCT05836480 Completed - Clinical trials for Mitral Regurgitation

Immediate Suboptimal Result of Mitral Valve Repair: Late Implications in a Matched Cohort Study

Start date: October 5, 2019
Phase:
Study type: Observational

Mitral valve regurgitation is a pathology affecting the left atrioventricular valve, conditioning the loss of the normal unidirectionality of the atrioventricular flow and therefore volumetric and pressure overload of the left heart chambers. In industrialized countries, the most common etiology of mitral regurgitation is degenerative mitral disease. Mitral valve repair surgery represents the gold standard for the treatment of severe degenerative mitral regurgitation. The expected optimal result would be the absence of residual post-procedural mitral regurgitation, even if it is not uncommon to obtain a valve with residual regurgitation of a mild degree. In some cases, for various reasons (technical difficulties, long aortic clamping time, advanced age, high pre-operative surgical risk), a suboptimal result is accepted, i.e. a post-procedural residual mitral regurgitation of even a moderate degree ( 0, 1+, or 2+/4+). The aim of the present study is to evaluate the late clinical and echocardiographic implications of suboptimal mitral valve repair with a paired-data cohort study

NCT ID: NCT05836376 Completed - Clinical trials for Mitral Regurgitation

Is Mitral Annuloplasty an Effective Treatment for Severe Atrial Functional MR?

Start date: November 30, 2020
Phase:
Study type: Observational

Atrial functional mitral regurgitation (MR) is caused by annular dilatation and flattering associated with altered atria/annulus dynamics in patients with severely dilated left atrium and normal leaflets anatomy. Inadequate leaflets adaption is considered a mechanistic culprit as well. Prevalence of at least moderate atrial functional MR varies between 4.7% and 7% in patients with permanent and long standing persistent atrial fibrillation (AF) and is even higher in patients with Heart Failure with preserved Ejection Fraction (HFpEF). Unlike secondary MR in the setting of left ventricular disease, results of surgical treatment of severe atrial functional MR has remained largely unspoken. The aim of this study is to analyze short and mid-term results of isolated annuloplasty in patients with severe, symptomatic atrial functional MR, in comparission to a matched cohort of patients with secondary MR.

NCT ID: NCT05784337 Completed - Clinical trials for Mitral Valve Regurgitation

Mi-thos® Transcatheter Mitral Valve Replacement(First-in-Man Study)

Start date: April 21, 2021
Phase: N/A
Study type: Interventional

To evaluate the effectiveness and safety of the Mi-thos® Transcatheter Mitral Valve Replacement System in the treatment of patients with moderate or greater mitral regurgitation who are at high risk for conventional surgery, or who are not candidates for conventional surgery.

NCT ID: NCT05774808 Completed - Clinical trials for Functional Mitral Regurgitation

Fate of Moderate Secondary Mitral Regurgitation in Patients Undergoing Aortic Valve Surgery for Severe Aortic Regurgitation

Start date: February 2, 2022
Phase:
Study type: Observational

Patients with severe aortic regurgitation (AR) may be affected, in many cases, by a concomitant moderate or severe mitral regurgitation (MR). Tethering of the mitral valve leaflets and/or annular dilatation, both consequences of left ventricular dilatation, represent the most common mechanisms underlying the development of MR which can therefore be defined as "secondary" in this case. When both mitral and aortic regurgitation are severe, patients show a decreased survival due to the pathophysiological consequences of the combination of these pathological conditions. In this case, surgery on both diseased valves is required to interrupt the natural history of the disease and is widely supported by current guidelines. On the other hand, little is known about the fate and prognostic implications of moderate MR secondary to severe AR and whether or not it should be treated at the time of aortic valve surgery. For this condition, the current guidelines do not provide specific recommendations, referring generically to the decision of the Heart Team. To date, there are few data describing the evolution of moderate MR in patients undergoing surgery for severe AR and insufficient data to support recommendations regarding the treatment of moderate MR concurrently with treatment of AR, so that this decision is now entrusted to the evaluation of the Heart Team. It is therefore desirable to evaluate the outcomes of these patients. The aim of this study is to evaluate the short- and long-term fate of secondary moderate MR in patients undergoing aortic valve replacement for severe AR.

NCT ID: NCT05774795 Completed - Clinical trials for Mitral Regurgitation

LOng-Term Fate of Moderate Aortic Regurgitation Left Untreated at the Time of Mitral Valve Surgery

Start date: March 24, 2021
Phase:
Study type: Observational

Multivalvular heart disease is a highly prevalent clinical condition that comprises 14.6% of the patients undergoing valvular surgery. Specifically, aortic valve regurgitation (AR) can be present in a considerable proportion of patients undergoing mitral valve (MV) surgery. In the Society of Thoracic Surgeons database, con- comitant aortic and mitral surgery accounted for 57.8% of the total multivalvular procedures with an unadjusted mortality rate of 10.7%. When both the aortic and MVs exhibit severe disease, con- comitant valve surgery is well-accepted by the surgical commu- nity and supported by current guidelines. On the other hand, when the aortic valve (AV) shows only moderate regurgita- tion, which would not be surgically treated if singly present, the appropriate management of the AV pathology at the time of MV surgery is still under debate. The American College of Cardiology guidelines state that aortic valve replacement (AVR) is reasonable (class IIa) in patients with moderate AR (stage B) while undergoing surgery on the ascend- ing aorta, a coronary artery bypass graft or MV surgery (level of evidence: C). Conversely, the latest European Society of Cardiology guidelines on valvular heart disease define as con- troversial the decision to treat the AV in patients with moderate AR who undergo MV surgery, considering the slow progression of this disease. In this group of patients, they advocate a heart team approach that will take into account the aetiology of AR, the life expectancy of the patient, the operative risk and other clinical factors. This disagreement may lead to uncertainty about how patients with less than severe AR should be managed during MV surgery, especially considering the burden of double-valve surgical procedures. The goal of this study is to evaluate the immediate and long- term outcomes, including the need for a new procedure on the AV, in patients with moderate AR at the time of MV surgery.

NCT ID: NCT05774769 Completed - Clinical trials for Degenerative Mitral Valve Disease

Commissural Closure to Treat Severe Mitral Regurgitation: Standing the Test of Time.

Start date: October 9, 2021
Phase:
Study type: Observational

Mitral regurgitation (MR) for degenerative disease is nowadays routinely treated with valve repair with excellent short and long term results in experienced centers. However, repair durability can varies according to the characteristics of the initial lesion, and better long term durability in isolated lesions of the posterior leaflets compared to anterior or bi-leaflets prolapse has been shown. A commissural MR can be caused by lesions of the anterior, posterior or both leaflets and several surgical techniques have been proposed to treat these lesions. However, long term outcomes of mitral valve repair (MVr) for isolated commissural flail or prolapse remain poor defined. In San Raffaele Hospital cardiac surgery, commissural lesions are usually treated with a functional approach, by means of edge-to-edge approximation of the anterior and posterior leaflet at the commissural area (commissural closure). The investigators previously reported the short and mid-term outcomes of this technique with satisfactory results. With this study the investigators aim to analyze the very long term clinical and echocardiographic results of isolated commissural lesions treated with commissural closure.

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.