Clinical trials: Valve Regurgitation, Mitral
Mitral Valve Regurgitation
Caisson Transcatheter Mitral Valve Replacement (TMVR) System Early Feasibility Study
The purpose of this study is to assess the safety and performance of the Caisson Interventional Transcatheter MitralValve Replacement (TMVR) system for the treatment of severe symptomatic MitralValve Regurgitation (MR).
- Trial name
- PRELUDE (NCT02768402)
- Testing
- Caisson TMVR System
- Where
- 13 sites in United States
- Volunteers
- 20 people
- Sponsor
- Caisson Interventional LLC
Mitral Valve Disease, Mitral Regurgitation
The Role of Left Atrial Fibrosis in Mitral Valve Repair Surgery (ALIVE Trial)
Rationale: Patients with mitral valve insufficiency suffer from left atrial remodeling. Atrial fibrosis is part of this remodeling process. The presence of atrial fibrosis is associated with adverse events.
- Conditions
- Mitral Valve Disease, Mitral Regurgitation, Surgery, Cardiac Valve Disease
- Trial name
- ALIVE (NCT05345730)
- Testing
- 3 DImensional Late Enhanced Gadolinium cardiac MRI scan
- Where
- Netherlands
- Volunteers
- 21 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Mitral Regurgitation, Mitral Disease
SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation
This study will evaluate the safety and functionality of the SAPIEN M3 System in patients with symptomatic, severe MR and will provide guidance for future clinical study designs utilizing the SAPIEN M3 System.
- Trial name
- SAPIEN M3 EFS (NCT03230747)
- Testing
- Edwards SAPIEN M3 System
- Where
- 9 sites in United States, Canada
- Volunteers
- 72 people
- Sponsor
- Edwards Lifesciences
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
Cardiovalve Transfemoral System - FIM Study
The Cardiovalve system is a replacement valve delivered through a transfemoral access and transseptal approach and is intended for symptomatic patients with Mitral regurgitation for whom surgical options are not feasible.
- Trial name
- NCT03958773
- Testing
- Cardiovalve transfemoral Mitral valve system
- Where
- Lithuania
- Volunteers
- 10 people
- Sponsor
- Cardiovalve Ltd.
Mitral Valve Regurgitation
Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation
To evaluate the safety and performance of the Tendyne™ Mitral Valve System when used as intended in a contemporary, real-world setting.
- Trial name
- RESOLVE-MR (NCT04818502)
- Testing
- Tendyne™ Mitral Valve System
- Where
- 36 sites in Austria, Belgium and 11 more
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
Mitral Regurgitation (MR)
Research on the Development and Application of a Preoperative Assessment Model for Transcatheter Mitral Valve Edge-to-Edge Repair Based on Visual Foundation Models
Mitral regurgitation (MR) is the most prevalent valvular heart disease in China. Transcatheter edge-to-edge repair (TEER) is currently the preferred treatment for patients with severe MR who face high surgical risks.
- Trial name
- NCT07247890
- Testing
- Model Construction, Validation, and Optimization
- Volunteers
- 800 people
- Sponsor
- Beijing Hospital
Mitral Valve Insufficiency
Prognostic Impact of Imaging Parameters in Patients With Primary Mitral Insufficiency by Prolapse (COHORTE-IM)
Degenerative mitral insufficiency secondary to valve prolapse is the most common valve disease in Western countries. In the absence of specific treatment, it spontaneously progresses to heart failure and death when it is severe.
- Trial name
- COHORTE-IM (NCT03962023)
- Testing
- Echocardiography and MRI
- Where
- France
- Volunteers
- 400 people
- Sponsor
- Lille Catholic University
Hypertrophic Obstructive Cardiomyopathy
Transapical Beating-Heart Septal Myectomy in Patient With Hypertrophic Obstructive Cardiomyopathy: a Multi-Center Study
The primary purpose of this study is to evaluate the feasibility, the safety and the efficacy of the transapical beating-heart septal myectomy for the treatment of hypertrophic obstructive cardiomyopathy.
- Trial name
- NCT05957419
- Testing
- Transapical beating-heart septal myectomy
- Where
- China
- Volunteers
- 1,000 people
- Sponsor
- Xiang Wei
Acute Heart Failure With Reduced Ejection Fraction, Decompensation; Heart, Congestive
The FOCUS-ADHF Registry
Acute heart failure (AHF) represents a significant clinical and economic burden due to its impact on patients' quality of life, poor prognosis, and high healthcare costs.
- Conditions
- Acute Heart Failure With Reduced Ejection Fraction, Decompensation; Heart, Congestive, Regurgitation, Mitral
- Trial name
- FOCUS-ADHF (NCT06726109)
- Where
- 4 sites in Belgium, Italy
- Volunteers
- 600 people
- Sponsor
- ASL Città di Torino
Hypertrophic Cardiomyopathy
Echocardiographic Perspectives on Transient Mitral Regurgitation After Septal Myectomy
Mitral regurgitation (MR) following septal myectomy for hypertrophic obstructive cardiomyopathy may persist despite relief of systolic anterior motion and left ventricular outflow tract obstruction.
- Trial name
- TMRSM_R (NCT07831811)
- Volunteers
- 150 people
- Sponsor
- University Health Network, Toronto
Mitral Valve Insufficiency, Mitral Regurgitation
Transcatheter Mitral Valvuloplasty Pilot Study
This study is to evaluate the efficacy and safety of Transcatheter Mitral Valvuloplasty for Severe Mitral Regurgitation
- Conditions
- Mitral Valve Insufficiency, Mitral Regurgitation, Mitral Valve Regurgitation
- Trial name
- MitraClip (NCT04351984)
- Testing
- MitraClip
- Where
- South Korea
- Volunteers
- 5 people
- Sponsor
- Duk-Woo Park, MD
Cardiac Septal Defects With Coarctation of the Aorta, Mitral Regurgitation
Comparison of Erector Spinae Block and Pecto-Intercostal Facial Block For Enhanced Recovery in Adult Cardiac Surgery
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.
- Trial name
- NCT05475561
- Testing
- Ultrasound guided Pecto-intercostal- fascial plane block, Ultrasound guided erector spinae plane block, Bupivacain
- Where
- Egypt
- Volunteers
- 60 people
- Sponsor
- Alexandria University
Mitral Regurgitation, Heart Failure
Strain Imaging in Patients With Functional Mitral Regurgitation, Treated With MitraClip
The aim of this study is i) to evaluate left ventricular global longitudinal strain and myocardial work in patients with heart failure and severe functional mitral regurgitation one year after MitraClip implantation and compare…
- Trial name
- NCT04218578
- Testing
- speckle tracking analysis of transthoracic echocardiogram
- Where
- Greece
- Volunteers
- 100 people
- Sponsor
- University of Athens
Mitral Valve Regurgitation
First-In-Human Clinical Study for Treatment of Severe Mitral Valve INsufficiency With Epygon™ TRanscatheter Mitral VAlve System
The EPYGON VALVE is an innovative mitral valve, intended for valve replacement of a native mitral valve through a minimally invasive implant procedure by means of a dedicated implant device.
- Trial name
- NCT04775108
- Testing
- Epygon™ Transcatheter Mitral Valve System
- Where
- 10 sites in Austria, Italy and 2 more
- Volunteers
- 40 people
- Sponsor
- Epygon
Hypertrophic Obstructive Cardiomyopathy
Surgical Treatment of Hypertrophic Obstructive Cardiomyopathy With Severe Mitral Insufficiency.
Compare the results of reconstruction and mitral valve replacement in the surgical treatment of obstructive hypertrophic cardiomyopathy with severe mitral insufficiency.
- Trial name
- NCT02054221
- Testing
- myoectomy, Mitral valve surgery
- Where
- Russia
- Volunteers
- 82 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Cardiovascular Diseases
Effectiveness and Safety of Mitral Valve Repair With the NeoChord DS1000 Artificial Chordae Delivery System Versus Conventional Surgery in Patients With Severe Primary Mitral Regurgitation Due to Isolated Leaflet Prolapse
The main objective is to assess the effectiveness and safety of the NeoChord DS1000 repair technique as compared with conventional open-heart on-pump mitral valve surgery in patients with severe primary mitral regurgitation.
- Trial name
- MITRACHORD (NCT02829749)
- Testing
- NeoChord beating heart mitral valve implantation, Control
- Where
- France
- Sponsor
- Hospices Civils de Lyon
Bioprosthesis Failure, Mitral Stenosis With Insufficiency
The China Mviv Registry
Mitral valve disease is the most common structure heart disease, and surgical valve replacement is an important treatment for severe mitral valve disease.
- Conditions
- Bioprosthesis Failure, Mitral Stenosis With Insufficiency, Mitral Stenosis, Mitral Regurgitation
- Trial name
- NCT05925335
- Testing
- Transseptal Transcatheter Mitral valve-in-valve Replacement
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Xiamen Cardiovascular Hospital, Xiamen University
Mitral Regurgitation
Cardioband With Transfemoral Delivery System
To evaluate the performance and safety of the Cardioband Adjustable Annuloplasty System for repair of functional mitral regurgitation.
- Trial name
- NCT01841554
- Testing
- Cardioband
- Where
- 11 sites in France, Germany and 4 more
- Volunteers
- 62 people
- Sponsor
- Edwards Lifesciences
Tricuspid Regurgitation
Feasibility Study of Dragonfly System for Severe Tricuspid Regurgitation
The study is designed to assess the feasibility of the DragonFly transcatheter mitral valve clamping system for the treatment of symptomatic severe tricuspid regurgitation.
- Trial name
- NCT04921605
- Testing
- DragonFly transcatheter mitral valve clamping system
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Hangzhou Valgen Medtech Co., Ltd