Clinical trials: Valve Regurgitation, Mitral
Severe Mitral Regurgitation, Preserved Ventricular Ejection Fraction
Use of Pre-operative Global Longitudinal Strain to Predict Post-operative Left Ventricular Dysfunction in Mitral Regurgitation Surgery
Primary mitral regurgitation (MR) is the second most frequent valve disease requiring surgery and it is important to identify patients whose outcome could be improved with surgery by considering the risks and benefits.
- Trial name
- DysPO IM (NCT03968601)
- Testing
- Mitral regurgitation surgery such as mitral valve replacement or repair
- Where
- France
- Volunteers
- 79 people
- Sponsor
- University Hospital, Clermont-Ferrand
Mitral Regurgitation, Mitral Valve Prolapse
Ventricular Arrhythmias in Patients Undergoing Mitral Valve Surgery
Study objectives: To assess the impact of mitral valve surgery for mitral regurgitation on ventricular arrhythmic burden and surrogate markers of fibrosis in patients with arrhytmogenic mitral valve prolapse (MVP) from baseline…
- Conditions
- Mitral Regurgitation, Mitral Valve Prolapse, Ventricular Tachycardia
- Trial name
- Mitra-VT (NCT06255457)
- Testing
- Mitral valve surgery
- Where
- Sweden
- Volunteers
- 90 people
- Sponsor
- Karolinska Institutet
Mitral Regurgitation
The PALMETTO Study
Prospective, single-arm, multicenter, non-randomized early feasibility study
- Trial name
- PALMETTO (NCT07885839)
- Testing
- ReValve System
- Volunteers
- 10 people
- Sponsor
- ReValve Solutions Inc.
Mitral Valve Insufficiency, Left Ventricular Systolic Dysfunction
Operative Mitral Valve Reconstruction in Functional mv Insufficiency With Reduced Systolic Ventricle Function
Functional mitral insufficiency poses a challenge with regard to the optimal time of intervention, particularly because they are frequently associated with left ventricular (LV) dilation and reduced LV ejection fraction (EF).
- Conditions
- Mitral Valve Insufficiency, Left Ventricular Systolic Dysfunction, Mitral Valve Prolapse
- Trial name
- REFORM-MR (NCT03470155)
- Testing
- mitral valve repair
- Where
- 6 sites in Germany
- Volunteers
- 105 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
Mitral Regurgitation, Valvular Heart Disease
Efficacy of MitraCLip Vs. PASCAL for the TrEAtment of MitraL REgurgiTation in an All-comer Population
To investigate potential differences in procedural outcomes of both commercially available transcatheter edge-to-edge mitral valve repair devices in a non-selected clinical setting.
- Conditions
- Mitral Regurgitation, Valvular Heart Disease, Heart Failure
- Trial name
- LEAFLET I (NCT06634121)
- Testing
- Transcatheter mitral valve edge-to-edge repair (M-TEER)
- Where
- Germany
- Volunteers
- 180 people
- Sponsor
- LMU Klinikum
Development of Standardized Assessment TAVI and MitraClip Procedures by Echocardiography, Aortic Stenosis
Examination of Valve Insufficiency Before and After MitraClip or TAVI Procedure by 3D Echocardiography Compared to MRI
Aim of the study is the definition of criteria for a standardized assessment of heart function by 3D echocardiographic procedures.
- Conditions
- Development of Standardized Assessment TAVI and MitraClip Procedures by Echocardiography, Aortic Stenosis, Mitral Valve Insufficiency
- Trial name
- 3D_TTE_TAVI (NCT01966146)
- Testing
- Echography GE Healthcare Vivid E9
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- RWTH Aachen University
Mitral Regurgitation
Outcome Registry and Assessment of New Edge-to-Edge Repair
The goal of this observational study is to learn about the long-term effects of Edge-tot-edge repair of all the patients of AmsterdamUMC, to treat their Mitral regurgitation (MR).
- Trial name
- ORANGE-TEER (NCT07108907)
- Where
- Netherlands
- Volunteers
- 300 people
- Sponsor
- Abby Geerlings
Atrial Fibrillation (AF), Mitral Valve (MV) Regurgitation
EPX-HTG for Structural Heart Procedures
To investigate and evaluate the benefits of adding EchoPixel Holographic Therapy Guidance to the current standard of care in Structural Heart (SH) procedures.
- Trial name
- EPX-HTG-2026 (NCT07705425)
- Testing
- Left Atrial Appendage Occlusion, Mitral Valve Transcatheter Edge to Edge Repair
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- EchoPixel, Inc.
Mitral Regurgitation
SQ-Kyrin TMVr FIM Study
A feasibility study to evaluate the effectiveness and safety of the SQ-Kyrin Transcatheter Edge-to-Edge Valve Repair System for the treatment of moderate-to-severe mitral regurgitation in patients with high surgical risk.
- Trial name
- NCT05040074
- Testing
- SQ-Kyrin Transcatheter Edge-to-Edge Valve Repair System
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Shanghai Shenqi Medical Technology Co., Ltd
Mitral Valve Insufficiency, Mitral Regurgitation
Degenerative Mitral Regurgitation in Intermediate Risk Patients
The main objective of this project is to determine intermediate-term echocardiographic outcomes in Medicare eligible patients (65 years of age and older) with moderate surgical risk who have undergone mitral valve surgery for…
- Trial name
- DMR (NCT02604745)
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Northwestern University
Mitral Regurgitation, Atrial Fibrillation (AF)
Study for the Identification of Subclinical Atrial Fibrillation In Patients With Significant Primary Mitral Regurgitation
The PRIME-LOOP study is a prospective cohort investigating the burden of atrial fibrillation (AF) and subclinical AF in patients with moderate-severe or severe primary mitral regurgitation (MR).
- Trial name
- PRIME-LOOP (NCT07377799)
- Where
- Denmark
- Volunteers
- 100 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Mitral Regurgitation
Change in LVEF Following Transcatheter Mitral Edge-To-Edge Repair
Little is known regarding the impact of transcatheter mitral valve edge-to-edge repair (TEER) on the acute changes in left ventricular ejection fraction (LVEF) and the effect of an acute reduction in LVEF, the so-called…
- Trial name
- MITRA-EF (NCT05311163)
- Testing
- MitraClip
- Where
- Israel
- Volunteers
- 4,000 people
- Sponsor
- Rabin Medical Center
Mitral Regurgitation
A Pan-Canadian, Retrospective Evaluation of MitraClip Safety and Efficacy
The PREMISE Registry is a retrospective, observational study that will evaluate the efficacy and safety of the MitraClip in real-world Canadian practice.
- Trial name
- PREMISE (NCT03592043)
- Testing
- MitraClip
- Where
- Canada
- Volunteers
- 1,191 people
- Sponsor
- Population Health Research Institute
Mitral Valve Regurgitation
Early Feasibility Study of the Neovasc Tiara™ Mitral Valve System
The purpose of this study is to evaluate the safety and initial performance of the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Transapical Delivery System.
- Trial name
- TIARA-I (NCT02276547)
- Testing
- Mitral valve replacement
- Where
- 10 sites in United States, Belgium and 1 more
- Volunteers
- 27 people
- Sponsor
- Shockwave Medical, Inc.
Mitral Regurgitation
Effect of MitraClip on Acute and Chronic Reverse Cardiac Remodeling Assessed by CMR: The MITRA-REVERSE Study
The purpose of this study is to use cardiac magnetic resonance (CMR) and echocardiography to define the anatomic and functional remodeling that results from MitraClip implantation.
- Trial name
- MITRA-REV (NCT02924363)
- Testing
- Cardiac MRI with or without contrast dye, Blood sample
- Where
- 2 sites in United States
- Volunteers
- 54 people
- Sponsor
- Dipan Shah
Mitral Valve Insufficiency, Coronary Artery Disease
Long Term Follow Up for CTSN Mitral Valve Repair Studies
This study is a continuation of two previous studies --- the Severe Ischemic Mitral Regurgitation (SMR) Trial (NCT00807040) and the Moderate Ischemic Mitral regurgitation (MMR) Trial (NCT00806988) --- to learn more about…
- Trial name
- NCT03066050
- Testing
- MV Repair, MV Replacement, CABG
- Where
- 24 sites in United States, Canada
- Volunteers
- 368 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Mitral Valve Prolapse, Mitral Regurgitation
Patient Specific Mitral Valve Modeling for Surgical Planning and Training
Mitral valve disease is a common pathologic problem occurring in approximately 2% of the general population but climbing to 10% in those over the age of 75 in Canada[1].
- Conditions
- Mitral Valve Prolapse, Mitral Regurgitation, Mitral Valve Disease
- Trial name
- NCT03609931
- Testing
- Mitral Valve Model
- Volunteers
- 65 people
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Mitral Regurgitation (MR)
The Prospective Segeberg Registry for Mitral Transcatheter Edge-to-Edge Repair
A Prospective Follow-up Assessment in Bad Segeberg for Patients with severe MR undergoing M-TEER
- Trial name
- SK M-CLIP (NCT07045753)
- Testing
- Transcatheter edge to edge repair
- Where
- Germany
- Volunteers
- 2,000 people
- Sponsor
- Segeberger Kliniken GmbH
Degenerative Mitral Regurgitation
CardioFlow Transcatheter Mitral Valve Replacement System Pre-market Clinical Investigation
This is a prospective, multi-center, single-arm study to assess the safety and effectiveness of Microport CardioFlow Transcatheter Mitral Valve Replacement system in the treatment of moderate to severe or severe degenerative…
- Trial name
- NCT07857343
- Testing
- Microport CardioFlow Mitral Valve Replacement System
- Where
- 3 sites in China
- Volunteers
- 152 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Residual Mitral Regurgitation
Multiparametric Protocol for Assessment of Intraprocedural Result of MITRACLIP Procedure
Quantification of residual mitral regurgitation (MR) after MitraClip may be challenging. Quantitative methods for severity assessment may be inaccurate and recent recommendations suggest an assessment of changes in both…
- Trial name
- IPCLIP-2020 (NCT06184789)
- Testing
- Echocardiographic assessment
- Where
- Italy
- Volunteers
- 80 people
- Sponsor
- IRCCS San Raffaele