Clinical trials: Degenerative Mitral Valve Disease
Degenerative Mitral Valve Disease
EXPLORE DMR: Early Feasibility Study of the PLAR Implant and Delivery System to Treat Degenerative Mitral Regurgitation
An early feasibility study to evaluate the safety and feasibility of the PLAR Implant and Delivery System to treat severe degenerative mitral regurgitation and to gather preliminary data on its performance thereby providing…
- Trial name
- NCT04679662
- Testing
- Transcatheter mitral valve repair (PLAR Implant and Delivery System)
- Where
- Brazil
- Sponsor
- Polares Medical SA
Mitral Regurgitation, Mitral Insufficiency
Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation
Prospective, controlled, multicenter clinical investigation with four trial cohorts: Randomized, Non-repairable, Severe Mitral Annular Calcification (MAC) and Severe Mitral Annular Calcification Continued Access Plan (MAC CAP).
- Conditions
- Mitral Regurgitation, Mitral Insufficiency, Mitral Valve Insufficiency, Cardiovascular Diseases
- Trial name
- SUMMIT (NCT03433274)
- Testing
- Tendyne Mitral Valve System, MitraClip System
- Where
- 78 sites in United States, Canada
- Volunteers
- 103 people
- Sponsor
- Abbott Medical Devices
Degenerative Mitral Valve Disease, Mitral Regurgitation
Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve…
- Conditions
- Degenerative Mitral Valve Disease, Mitral Regurgitation, Mitral Insufficiency, Functional Mitral Regurgitation
- Trial name
- CLASP IID/IIF (NCT03706833)
- Testing
- Edwards PASCAL System, Abbott Mitraclip System
- Where
- 81 sites in United States, Canada and 2 more
- Volunteers
- 1,247 people
- Sponsor
- Edwards Lifesciences
Degenerative Mitral Valve Disease
Clinical and Fundamental Aspects of Prosthetics and Translocation of Mitral Valve Chordae
The study compares the efficacies of two surgical procedures for the treatment of mitral valve prolapse due to myxomatous degeneration of the mitral valve: the chordae replacement and the translocation of secondary mitral valve…
- Trial name
- NCT03674593
- Testing
- Mitral valve chordae prosthesis, Mitral valve chordae translocation
- Where
- Russia
- Volunteers
- 64 people
- Sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
Degenerative Mitral Valve Disease
Transcatheter vs. Surgical Treatment of Degenerative Mitral Regurgitation
The goal of this observational study is to compare the outcomes of transcatheter edge-to-edge repair (TEER) versus surgical mitral valve repair for degenerative mitral regurgitation (DMR) over the long term. The study aims to: 1.
- Trial name
- DMR (NCT07605715)
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Cedars-Sinai Medical Center
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, Degenerative Mitral Valve Disease
Safety and Efficacy of the GeminiOne Transcatheter Valve Edge-to-Edge Repair System in Patients With Moderate-severe or Severe Degenerative Mitral Regurgitation
To observe and evaluate the safety and efficacy of the GeminiOne Transcatheter Valve Edge-to-Edge Repair System in Patients With Moderate-severe or Severe Degenerative Mitral Regurgitation through a prospective, multicenter…
- Trial name
- NCT05655897
- Testing
- GeminiOne Transcatheter Valve Edge-to-Edge Repair System
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Peijia Medical Technology (Suzhou) Co., Ltd.
Severe Degenerative Mitral Regurgitation Due to Mid-segment Posterior Leaflet Prolapse
Observational Registry on the HARPOON Device
To collect data on the HARPOON™ Mitral Valve Repair System for use in patients with severe degenerative mitral regurgitation due to posterior leaflet prolapse.
- Trial name
- REPLICATE (NCT04393779)
- Testing
- HARPOON Beating Heart Mitral Valve Repair System (MVRS)
- Where
- 7 sites in Germany, Spain and 1 more
- Volunteers
- 26 people
- Sponsor
- Edwards Lifesciences
Degenerative Mitral Valve Disease
Early Feasibility Study of the PLAR Implant and Delivery System to Treat Degenerative Mitral Regurgitation
An early feasibility study to evaluate the safety and feasibility of the PLAR Implant and Delivery System to treat severe degenerative mitral regurgitation and to gather preliminary data on its performance thereby providing…
- Trial name
- EXPLORE DMR (NCT04666480)
- Testing
- Transcatheter mitral valve repair
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Polares Medical SA
Degenerative Mitral Valve Disease
Clinical Study of NovoClasp for Treating Moderate to Severe and Severe Degenerative Mitral Regurgitation
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…
- Trial name
- NCT06021509
- Testing
- NovoClasp® transcatheter mitral valve clip and steerable guide catheter
- Where
- China
- Volunteers
- 102 people
- Sponsor
- Enlight Medical Technologies (Shanghai) Co., Ltd
Degenerative Mitral Valve Disease
Long Term Results in Redo Mitral Valve Surgery After Mitral Valve Repair
The current gold standard for severe mitral regurgitation is mitral valve plasty (PLM). The surgery allows the repair of the mitral valve, therefore without the need for mitral valve replacement (SVM), which involves the…
- Trial name
- NCT05839782
- Testing
- Mitral valve repair (PLM), Mitral valve replacement
- Where
- Italy
- Volunteers
- 108 people
- Sponsor
- Michele De Bonis
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
Degenerative Mitral Valve Disease
Commissural Closure to Treat Severe Mitral Regurgitation: Standing the Test of Time.
Mitral regurgitation (MR) for degenerative disease is nowadays routinely treated with valve repair with excellent short and long term results in experienced centers.
- Trial name
- NCT05774769
- Testing
- Commissural edge to edge mitral valve repair
- Where
- Italy
- Volunteers
- 125 people
- Sponsor
- Michele De Bonis
Degenerative Mitral Valve Disease
Effect of RT3D-TEE-guided Mitral Valve Repair on Outcomes in Patients With Degenerative Mitral Valve Disease
The aim of this randomized controlled trial to investigate the effects of Real-time 3D transesophageal echocardiography (RT3D-TEE)-guided mitral valve repair on surgical failure and 1-year reoccurrence of mitral valve…
- Trial name
- TEEMR (NCT05595226)
- Testing
- RT3D-TEE-guided mitral valve repair
- Where
- China
- Volunteers
- 338 people
- Sponsor
- Sheng Liu
Mitral Valve Insufficiency, Mitral Valve Prolapse
European FIH Study - NeoChord Transcatheter Mitral Repair System for Symptomatic Mitral Regurgitation
Safety and performance evaluation of the NeoChord Transcatheter Mitral Repair System in patients with degenerative mitral valve regurgitation.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Prolapse, Degenerative, Mitral Regurgitation
- Trial name
- NCT05425628
- Testing
- NeoChord Transcatheter Mitral Repair System (or "NeoChord System")
- Volunteers
- 30 people
- Sponsor
- NeoChord
Degenerative Mitral Valve Disease, Mitral Valve Regurgitation
A Prospective, Multicenter Study to Evaluate the JensClip Transcatheter Valve Repair System
The clinical trial study is designed as a prospective, multicenter, single-group target value clinical study to evaluate the safety and efficacy of the clinical investigational product and to evaluate its performance using the…
- Trial name
- NCT05417945
- Testing
- JensClip transcatheter valve repair system
- Volunteers
- 124 people
- Sponsor
- Jenscare Scientific
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 Valve Insufficiency, Mitral Valve Prolapse
Primary Mitral Regurgitation Repair
This longitudinal cohort study evaluates the relationship of myocardial tissue markers characteristics assessed by cardiac MRI, with clinical measures of symptoms and functions in adults with primary mitral regurgitation.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Prolapse, Chronic Mitral Disease, Mitral Regurgitation
- Trial name
- NCT04067635
- Where
- United States
- Volunteers
- 116 people
- Sponsor
- Eric Y. Yang, MD PhD
Degenerative Mitral Valve Disease
Mitral Annuloplasty Rings RCT
Recently published work has suggested that mitral valve annuloplasty ring type may affect the development of post-repair mitral stenosis resulting in adverse intracardiac hemodynamics and poor functional status.
- Trial name
- NCT03290872
- Testing
- Carpentier Edwards Physio 2 Complete flexible mitral ring, Simplici T Partial flexible mitral annuloplasty ring
- Volunteers
- 50 people
- Sponsor
- University Health Network, Toronto