Clinical trials: Mitral Valve Repair
Functional Mitral Regurgitation, Heart Failure
The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With FMR
The objective of this prospective, randomized, double- blinded (patient and assessors), sham-controlled clinical trial is to assess the safety and efficacy of the CMCS in treating heart failure with functional regurgitation (FMR).
- Conditions
- Functional Mitral Regurgitation, Heart Failure, Mitral Valve Insufficiency, Heart Diseases
- Trial name
- NCT03142152
- Testing
- Carillon Mitral Contour System, Guideline Directed Heart Failure Medication
- Where
- 92 sites in United States, Canada and 6 more
- Volunteers
- 300 people
- Sponsor
- Cardiac Dimensions, Inc.
Mitral Regurgitation
MitraClip® After Surgical Mitral Valve Repair
Percutaneous edge-to-edge repair of the mitral valve has been shown to be a safe and effective alternative treatment option for selected patients at high risk for cardiac surgery.
- Trial name
- MVRepair (NCT02853955)
- Testing
- Percutaneous edge-to-edge repair of the mitral valve
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- LMU Klinikum
Degenerative Mitral Valve Disease, Mitral Valve Regurgitation
Chordal Repair for Transcatheter Mitral Valve Repair (TMVr)
A multi-center evaluation of the Pipeline chordal repair system for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve repair.
- Trial name
- NCT04281940
- Testing
- Transcatheter implantation of chordal repair system
- Where
- 4 sites in Georgia, Paraguay and 1 more
- Volunteers
- 7 people
- Sponsor
- Pipeline Medical
Mitral Regurgitation
The Papillary Muscle Approximation Provide Stability of Mitral Valve Repair for Ischemic Mitral Regurgitation
Recent publications show that an adjunctive subvalvular repair during mitral annuloplasty for secondary mitral regurgitation effective in preventing recurrent regurgitation.
- Trial name
- PMA (NCT03038204)
- Testing
- The papillary muscle approximation
- Volunteers
- 100 people
- Sponsor
- The Federal Centre of Cardiovascular Surgery, Russia
Mitral Valve Regurgitation, Mitral Valve Prolapse
CE Mark Study for the Harpoon Medical Device in Poland
The purpose of this study is to evaluate the safety and performance of the Harpoon Medical TSD-5. The Harpoon device will provide many significant advantages over current surgical interventions including: 1) a small minimally…
- Conditions
- Mitral Valve Regurgitation, Mitral Valve Prolapse, Mitral Valve Insufficiency
- Trial name
- NCT02432196
- Testing
- Harpoon Medical Device
- Where
- 2 sites in Poland
- Volunteers
- 26 people
- Sponsor
- Edwards Lifesciences
Degenerative Mitral Valve Disease, Mitral Regurgitation
Long Term Results of Surgical and Percutaneous Double Orefices Mitral Repair in Patient With p2 Prolapse Causing Degenerative Mitral Regurgitation
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…
- Trial name
- NCT05836532
- Testing
- Central edge-to-edge
- Where
- Italy
- Volunteers
- 110 people
- Sponsor
- Michele De Bonis
Mitral Valve Insufficiency, Mitral Valve Regurgitation
EVEREST II Pivotal Study High Risk Registry (HRR)
Prospective, multi-center, single arm registry. Clinical follow-up at discharge, 30 days, 6, 12, 18 and 24, months, and 3, 4 and 5 years.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation
- Trial name
- HRR (NCT01940120)
- Testing
- Percutaneous mitral valve repair using MitraClip implant
- Where
- 2 sites in United States
- Volunteers
- 78 people
- Sponsor
- Abbott Medical Devices
Mitral Regurgitation, Local Anaesthesia
Deep Sedation Instead of General Anaesthesia in Percutaneous Mitral Valve Repair Using the MitraClip® System
Percutaneous mitral valve repair (PMVR) with the MitraClip® system has emerged as a therapeutic alternative to surgical valve repair in patients who are at high risk and unsuitable for surgery.
- Conditions
- Mitral Regurgitation, Local Anaesthesia, Percutaneous Repair
- Trial name
- NCT02023762
- Volunteers
- 21 people
- Sponsor
- Heinrich-Heine University, Duesseldorf
Mitral Regurgitation
Artificial Intelligence Assisting Transcatheter Mitral Edge-to-Edge Repair
This multicenter, retrospective study develops and validates artificial intelligence (AI)-based semantic segmentation algorithms for intraprocedural transesophageal echocardiography (TEE) during Transcatheter Mitral Edge-to-Edge…
- Trial name
- AutoClip (NCT07632794)
- Where
- 3 sites in China, Italy
- Volunteers
- 1,500 people
- Sponsor
- Mi Chen
Heart Valvular Disease
Multi-center Research Clinical Trial Protocol for Etiology-pathology and Repair Classification of Mitral and Tricuspid Valves
The choice of valve repair is very important in the treatment of cardiac valve disease, and its core is the etiology pathology analysis, which directly determines the design of repair strategy and the quality of postoperative…
- Trial name
- NCT07863531
- Testing
- Valve repair, Valve replacement
- Volunteers
- 200 people
- Sponsor
- Keli Huang
This Study is Being Conducted to Collect Echocardiographic Data to Test the Lumify Ultrasound With Hemodynamic Automation Device
Testing Automated Echocardiography
The purpose of this research is to determine if software can accurately predict certain heart parameters from chest wall ultrasound (non-radiation, non-invasive, imaging modality).
- Trial name
- NCT04943965
- Testing
- Ultrasound imaging
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- University of Pennsylvania
Mitral Valve Insufficiency, Heart Failure
Effectiveness of Surgical Mitral Valve Repair Versus Medical Treatment for People With Significant Mitral Regurgitation and Non-ischemic Congestive Heart Failure
Mitral regurgitation (MR), also known as mitral insufficiency, is a condition in which the heart's mitral valve, located between two of the heart's main chambers, does not firmly shut, allowing blood to leak backwards within the…
- Trial name
- SMMART-HF (NCT00608140)
- Testing
- Surgical mitral valvuloplasty with placement of annular ring (SMVR), Optimal medical therapy (OMT)
- Where
- 9 sites in United States, Canada
- Volunteers
- 2 people
- Sponsor
- Duke University
Mitral Valve Regurgitation, Mitral Regurgitation
The Role of Myocardial Fibrosis in Degenerative Mitral Regurgitation
This study investigates the hypothesis that diffuse interstitial cardiac fibrosis develops in response to chronic volume overload from severe degenerative mitral regurgitation.
- Trial name
- NCT02355418
- Testing
- Mitral valve repair
- Where
- United Kingdom
- Volunteers
- 147 people
- Sponsor
- University Hospital Birmingham NHS Foundation Trust
Mitral Regurgitation, Functional Mitral Regurgitation
CAP-TEER: CerebrAl Protection During Transcatheter Edge-to-edge Repair
Transcatheter edge-to-edge repair of the mitral valve (M-TEER) is a well-established endovascular treatment option for patients with severe mitral regurgitation who are at high risk for surgery-related complications.
- Conditions
- Mitral Regurgitation, Functional Mitral Regurgitation, Degenerative Mitral Valve Regurgitation
- Trial name
- NCT06814210
- Testing
- Cerebral Embolic Protection
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Xiao-dong Zhuang
Heart; Decompensation, Right Ventricle, Echocardiography
The Right Ventricular Responses to Mild Hypercarbia After Mitral Valve Repair Surgery
The aims of the study is to investigate the right ventricular responses to mild hypercarbia after mitral valve prolapse repair surgery by the measurements obtained on pulmonary arterial catheter and transesophageal…
- Conditions
- Heart; Decompensation, Right Ventricle, Echocardiography, Hypercapnia
- Trial name
- NCT02757573
- Testing
- Hypercarbia
- Where
- Finland
- Volunteers
- 31 people
- Sponsor
- Tampere University Hospital
Degenerative Mitral Valve Disease
Safety and Effectiveness Study of Dragonfly System for Degenerative Mitral Regurgitation
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 (DMR) in high surgical risk…
- Trial name
- NCT04734756
- Testing
- Dragonfly Transcatheter Mitral Valve Repair System
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Hangzhou Valgen Medtech Co., Ltd
Mitral Regurgitation
Invasive Hemodynamic Response to Transcatheter Edge-to-Edge Mitral Valve Repair
Studying the effects of Trans-catheter Mitral Valve Repair (TMVr) on the hemodynamics and biomarkers in patients with severe mitral valve regurgitation.
- Trial name
- NCT04200378
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Mayo Clinic
Mitral Regurgitation
Edge-To-Edge Technique Used as a Bailout in Case of Sub-Optimal Mitral Repair: Very Long-Term Results
The absence of residual mitral regurgitation (MR) after mitral valve repair is of paramount importance for the long term durability of the valve repair.
- Trial name
- NCT05733988
- Testing
- Bailout edge to edge
- Where
- Italy
- Volunteers
- 81 people
- Sponsor
- Michele De Bonis
Mitral Stenosis
Assessment of Right Ventricular Function in Patients With Severe Mitral Stenosis Before and After Balloon Mitral Valvuloplasty
To detect short-term impacts of successful balloon mitral valvuloplasty on right ventricular function
- Trial name
- NCT06067815
- Volunteers
- 30 people
- Sponsor
- Assiut University
Mitral Regurgitation
The Multicenter Clinical Trial of a Novel TEER Decive (V-CLASP Trial)
This is a single-group, prospective, multicenter clinical research using the single-arm objective performance criteria. Patients with moderate to severe mitral regurgitation and a high surgical risk will be treated with…
- Trial name
- NCT05391802
- Testing
- Transcatheter mitral valve repair
- Volunteers
- 120 people
- Sponsor
- Shanghai Zhongshan Hospital