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Mitral Valve Insufficiency clinical trials

View clinical trials related to Mitral Valve Insufficiency.

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NCT ID: NCT06039592 Recruiting - Clinical trials for Congenital Mitral Insufficiency

Study of Innovative Drug Strategies in Improving Left Ventricular Function After Mitral Repair

Start date: April 1, 2022
Phase:
Study type: Observational [Patient Registry]

The goal of this observational study is to compare the safety and effectiveness of a modified drug therapy with traditional drug therapy in pediatric patients after mitral repair. The main questions it aims to answer are: - Can a modified drug therapy improve both left ventricular and mitral valve function in pediatric patients after mitral repair? - Can the adverse drug reactions caused by the modified drug therapy be non-inferior (clinically acceptable) to those of the traditional drug therapy? Participants will be assigned to either the Modified Drug Therapy Group (comprising angiotensin-converting enzyme inhibitor (ACE-I), beta-blockers, diuretics, potassium supplements, and spironolactone) or the Traditional Drug Therapy Group (diuretics and potassium supplements) based on personal preferences and clinical assessments by their attending physicians. They will undergo a 6-months course of medication. Additionally, echocardiography, electrocardiograms, complete blood counts, biochemical tests, and measurements of N-terminal pro-brain natriuretic peptide (NT-proBNP) were conducted before the initiation of medication therapy and at 1 month, 3 months, and 6 months after treatment commencement. Researchers will compare the Modified Drug Therapy Group and the Traditional Drug Therapy Group to see if the recurrence rate of moderate to severe mitral valve regurgitation, as assessed by echocardiography after 6 months of treatment, is lower in the former than in the latter.

NCT ID: NCT06038838 Not yet recruiting - Clinical trials for Mitral Regurgitation

Feasibility Study of the Tioga TMVR System

Start date: December 1, 2023
Phase: N/A
Study type: Interventional

The study is aimed to assess the safety and feasibility of the Tioga TMVR System in treating patients with symptomatic MR (MR>=3+)

NCT ID: NCT06037447 Recruiting - Clinical trials for Congenital Mitral Insufficiency

Study of Innovative Strategies for Mitral Valve Repair

Start date: April 1, 2022
Phase:
Study type: Observational [Patient Registry]

The goal of this observational study is to compare the safety and effectiveness of a 3-steps standardized repair-oriented strategy with annuloplasty only in pediatric patients with mild to moderate mitral valve regurgitation. The main questions it aims to answer are: - Can 3-steps standardized repair-oriented strategy improve both left ventricular and mitral valve function in pediatric patients with mild to moderate mitral valve regurgitation? - Can surgical complications caused by the 3-steps standardized repair-oriented strategy be non-inferior (clinically acceptable) to annuloplasty only? Participants will be assigned to either the Standardized Group (including subvalvular apparatus rehabilitation (leaflet plication if chordae absent on leaflet margin, mal-connected chordae resection if chordae mal-connected to leaflet body, papillary muscle splitting if short chordae or dysplastic or fused papillary muscle etc.), leaflets repair (leaflets plication if functional leaflet prolapse, leaflet cleft closure and patch augmentation for anatomical leaflet defect, etc.) and annuloplasty (posterior annuloplasty for annular dilatation and shallow leaflet coaptation, etc.)) or the Annuloplasty Group (annuloplasty only during mitral repair surgeries. Additionally, echocardiography, electrocardiograms, and measurements of N-terminal pro-brain natriuretic peptide (NT-proBNP) were conducted before the initiation of surgery and at 1 months, 3 months, and 6 months after mitral repair. Researchers will compare the Standardized Group and the Annuloplasty Group to see if the recurrence rate of moderate to severe mitral valve regurgitation, as assessed by echocardiography after 6 months of surgery, is lower in the former than in the latter.

NCT ID: NCT06037434 Recruiting - Clinical trials for Congenital Mitral Insufficiency

Study of Innovative Drug Treatment Therapy for Pediatric Mitral Regurgitation

Start date: April 1, 2022
Phase:
Study type: Observational [Patient Registry]

The goal of this observational study is to compare the safety and effectiveness of a modified drug therapy with traditional drug therapy in pediatric patients with mild to moderate mitral valve regurgitation. The main questions it aims to answer are: - Can a modified drug therapy improve both left ventricular and mitral valve function in pediatric patients with mild to moderate mitral valve regurgitation? - Can the adverse drug reactions caused by the modified drug therapy be non-inferior (clinically acceptable) to those of the traditional drug therapy? Participants will be assigned to either the Modified Drug Therapy Group (comprising angiotensin-converting enzyme inhibitor (ACE-I), beta-blockers, diuretics, potassium supplements, and spironolactone) or the Traditional Drug Therapy Group (diuretics and potassium supplements) based on personal preferences and clinical assessments by their attending physicians. They will undergo a one-year course of medication. Additionally, echocardiography, electrocardiograms, complete blood counts, biochemical tests, and measurements of N-terminal pro-brain natriuretic peptide (NT-proBNP) were conducted before the initiation of medication therapy and at 3 months, 6 months, and 12 months after treatment commencement. Researchers will compare the Modified Drug Therapy Group and the Traditional Drug Therapy Group to see if the recurrence rate of moderate to severe mitral valve regurgitation, as assessed by echocardiography after 12 months of treatment, is lower in the former than in the latter.

NCT ID: NCT06021509 Active, not recruiting - Clinical trials for Degenerative Mitral Valve Disease

Clinical Study of NovoClasp for Treating Moderate to Severe and Severe Degenerative Mitral Regurgitation

Start date: May 15, 2022
Phase: N/A
Study type: Interventional

To validate the safety and efficacy of transcatheter edge-to-edge repair (TEER) using the NovoClasp® transcatheter mitral valve clip and steerable guide catheter in the treatment of moderate to severe and severe degenerative mitral regurgitation (DMR).

NCT ID: NCT05991284 Recruiting - Clinical trials for Heart Failure With Preserved Ejection Fraction

Sacubitril-Valsartan in Heart Failure With Preserved Ejection Fraction and Secondary Mitral Valve Regurgitation

PRAISE-MR
Start date: February 14, 2024
Phase: Phase 4
Study type: Interventional

The main objective of this study is to assess the hemodynamic effects of sacubitril-valsartan in patients with heart failure with preserved ejection fraction and at least moderate atrial functional mitral regurgitation (AFMR), using a combination of cardiopulmonary exercise testing and stress echocardiography (referred to as CPETecho) at baseline and after six months of therapy. The patients included in this study will be randomly assigned to receive sacubitril-valsartan as an adjunct to standard medical care, as opposed to adhering solely to the standard of care which involves sodium-glucose cotransporter-2 (SGLT-2) inhibitor and mineralocorticoid receptor antagonist (MRA).

NCT ID: NCT05988450 Active, not recruiting - Clinical trials for Functional Mitral Regurgitation

Safety and Effectiveness Study of SQ-Kyrin TMVr System for Functional Mitral Regurgitation

Start date: March 7, 2022
Phase: N/A
Study type: Interventional

To verify the safety and effectiveness of transcatheter mitral valve clip delivery system and steerable guide catheter produced by Shanghai Shenqi Medical Technology Co., Ltd. in patients with moderate-severe (3 +) or severe (4 +) functional MR (functional MR) who still have symptoms after full treatment.

NCT ID: NCT05965258 Recruiting - Clinical trials for Functional Mitral Regurgitation

Phenotypic Classification of FMR With CMR

Start date: August 29, 2023
Phase:
Study type: Observational

The goal of the current research is to develop personalized risk prediction for functional mitral regurgitation (FMR) patients through explainable unsupervised phenomapping enriched with advanced cardiac magnetic resonance (CMR) imaging biomarkers, and to determine the CMR predictors of reverse remodeling following modern therapies for FMR. The prospective study entails aiming to recruit 360 adult patients (ages >18 years) with EF 10-50% and FMR RF> 20%, who are clinically referred for CMR evaluation. Patients who enroll in our study will be referred for optimization of mGDMT and will undergo follow-up CMR studies at 6months. NICM patients who are fully medically optimized with significant FMR at the time of the baseline CMR and are referred for Mitraclip treatment will undergo follow-up CMR 6 months from Mitraclip intervention. NICM patients referred for mGDMT optimization, but have persistent or progressive FMR at the time of 6 month follow-up CMR and referred for Mitraclip therapy, will undergo a 2nd follow-up CMR 6 months from Mitraclip therapy.

NCT ID: NCT05931900 Enrolling by invitation - Clinical trials for Functional Mitral Regurgitation

The JensClip Transcatheter Valve Repair System for Treating Functional Mitral Regurgitation

Start date: August 2023
Phase: N/A
Study type: Interventional

To evaluate the efficacy and safety of the JensClip transcatheter valve repair system for patients with moderate-severe or greater (MR ≥ 3+) functional mitral regurgitation (FMR) who have received adequate treatment but are still symptomatic.

NCT ID: NCT05927441 Not yet recruiting - Clinical trials for Mitral Valve Insufficiency

DragonFly EU Pivotal Study

Start date: December 1, 2023
Phase: N/A
Study type: Interventional

To confirm the effectiveness and safety of the DragonFly Transcatheter Mitral Valve Repair System for the treatment of symptomatic moderate-to-severe (3+) or severe (4+) degenerative mitral regurgitation in high surgical risk subjects and symptomatic moderate-to- severe (3+) or severe (4+) functional mitral regurgitation subjects who remained clinically symptomatic after adequate treatment.