Clinical trials: Degenerative Mitral Valve Regurgitation
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 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
Flexible Band vs Rigid Ring for Degenerative Mitral Valve Disease
The study evaluates the results of mitral valve repair with flexible band in comparison with rigid ring in patients undergoing mitral valve repair for degenerative mitral valve disease
- Trial name
- NCT03278574
- Testing
- Mitral valve repair, Ring annuloplasty with posterior band, Ring annuloplasty with complete ring
- Volunteers
- 171 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Mitral Valve Regurgitation (Degenerative or Functional)
TVMR With the INNOVALVE System Trial - Early Feasibility Study
Study to evaluate the safety and performance of the INNOVALVE system
- Trial name
- TWIST-EFS (NCT04919980)
- Testing
- INNOVALVE system
- Where
- 21 sites in United States
- Volunteers
- 85 people
- Sponsor
- Edwards Lifesciences
Bipolar Disorder, Frontotemporal Dementia, Behavioral Variant
A Study of the Behavioral Variant of Frontotemporal Dementia and Bipolar Disorder: a Neuroimaging and Epigenetics Integrated Approach
The aim of this study is to investigate the selective epigenetic modifications and their effect on brain's morphology and functionality in the frontotemporal dementia behavioral variant and bipolar disorder.
- Trial name
- DISBAND (NCT06706687)
- Testing
- DISBAND protocol
- Where
- Italy
- Volunteers
- 210 people, healthy volunteers welcome
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Mitral Regurgitation, Mitral Insufficiency
ATLAS (AltaValve) Pivotal Trial
This is a prospective, single arm, multicenter, clinical trial designed to evaluate the safety and performance of the AltaValve System for the treatment of mitral regurgitation in a targeted patient population.
- Conditions
- Mitral Regurgitation, Mitral Insufficiency, Mitral Valve Incompetence, Mitral Valve Regurgitation
- Trial name
- ATLAS (NCT06465745)
- Testing
- AltaValve System.
- Where
- 58 sites in United States, Canada and 5 more
- Volunteers
- 450 people
- Sponsor
- 4C Medical Technologies, Inc.
Mitral Regurgitation
Valveclip® Transcatheter Mitral Valve Repair Study
The purpose of this clinical trial is to evaluate the effectiveness and safety of the transcatheter mitral valve repair system in the treatment of patients with moderate or above degenerative mitral regurgitation.
- Trial name
- NCT05021614
- Testing
- Valveclip® Transcatheter mitral valve repair
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Shanghai NewMed Medical Co., Ltd.
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
Mitral Valve Regurgitation, Mitral Valve Prolapse
Safety and Early Feasibility Study of the Harpoon Medical Device (EFS)
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
- EFS (NCT02771275)
- Testing
- Harpoon Medical Device
- Where
- 2 sites in Poland
- Volunteers
- 13 people
- Sponsor
- Edwards Lifesciences
Parkinson's Disease
31P-MRS Imaging to Assess the Effects of CNM-Au8 on Impaired Neuronal Redox State in Parkinson's Disease
REPAIR-PD is a single-center open label pilot, sequential group, investigator and patient blinded study to assess the CNS metabolic effects, safety, pharmacokinetics, and pharmacodynamics of CNM-Au8 in patients who have been…
- Trial name
- REPAIR-PD (NCT03815916)
- Testing
- Gold Nanocrystals
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Clene Nanomedicine
Amyotrophic Lateral Sclerosis
31P-MRS Imaging to Assess the Effects of CNM-Au8 on Impaired Neuronal Redox State in Amyotrophic Lateral Sclerosis (REPAIR-ALS)
REPAIR-ALS is a single-center open label pilot, sequential group, investigator and patient blinded study to assess the CNS metabolic effects, safety, pharmacokinetics, and pharmacodynamics of CNM-Au8 in patients who have been…
- Trial name
- REPAIR-ALS (NCT03843710)
- Testing
- Gold Nanocrystals
- Where
- United States
- Sponsor
- Clene Nanomedicine
Mitral Valve Insufficiency, Mitral Valve Regurgitation
Feasibility Study of a Percutaneous Mitral Valve Repair System.
Prospective, multi-center, Phase I study of the Evalve Cardiovascular Valve Repair System (CVRS) in the treatment of mitral valve regurgitation. Patients will undergo 30-day, 6 month, 12 month, and 5 year clinical follow-up.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation
- Trial name
- EVEREST(I) (NCT00209339)
- Testing
- Percutaneous mitral valve repair (MitraClip Implant)
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- Abbott Medical Devices
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
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
Mitral Valve Regurgitation (Degenerative or Functional)
TVMR With the Innovalve System Trial - Pilot in Georgia
Study to evaluate the safety and performance of the Innovalve mitral valve replacement system
- Trial name
- TWIST-PILOT-GE (NCT05682066)
- Testing
- Innovalve MR system
- Where
- Georgia
- Volunteers
- 11 people
- Sponsor
- Edwards Lifesciences
Mitral Valve Regurgitation (Degenerative or Functional)
TVMR With the Innovalve System Trial - Pilot Study in Italy
Study to evaluate the safety and performance of the Innovalve mitral valve replacement system
- Trial name
- TWIST-PILOT-IT (NCT05010746)
- Testing
- Innovalve TMVR system
- Where
- Italy
- Volunteers
- 4 people
- Sponsor
- Edwards Lifesciences
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 Valve Insufficiency, Mitral Valve Regurgitation
Real World Expanded Multicenter Study of the MitraClip® System (REALISM)
Prospective, multicenter, continued access registry of the MitraClip® Cardiovascular Valve Repair System in the treatment of mitral valve regurgitation.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation
- Trial name
- REALISM (NCT01931956)
- Testing
- MitraClip® implant
- Where
- 38 sites in United States
- Volunteers
- 965 people
- Sponsor
- Abbott Medical Devices
Mitral Regurgitation, Mitral Insufficiency
AltaValve Early Feasibility Study Protocol
Prospective, single-arm, multicenter study to evaluate the safety and performance of the AltaValve for the treatment of moderate to severe or severe mitral valve regurgitation in subjects who are considered high risk for…
- Conditions
- Mitral Regurgitation, Mitral Insufficiency, Mitral Valve Incompetence, Mitral Valve Regurgitation
- Trial name
- NCT03997305
- Testing
- AltaValve
- Where
- 12 sites in United States
- Volunteers
- 15 people
- Sponsor
- 4C Medical Technologies, Inc.