Clinical trials: Functional Mitral Regurgitation
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, 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 Insufficiency, Heart Failure
Carillon Mitral Contour System® for Reducing Functional Mitral Regurgitation
The objective of this prospective, multi-center, randomized, double-blind trial is to assess the safety and efficacy of the Carillon Mitral Contour System in treating functional mitral regurgitation (FMR) associated with heart…
- Trial name
- REDUCE FMR (NCT02325830)
- Testing
- Carillon Mitral Contour System
- Where
- 31 sites in Australia, Czechia and 6 more
- Volunteers
- 163 people
- Sponsor
- Cardiac Dimensions Pty Ltd
Ornithine Transcarbamylase Deficiency
Investigation of Brain Nitrogen in Partial Ornithine Transcarbamylase Deficiency (OTCD) Using 1 H MRS, DTI, and fMRI
The purpose of this study is to use various types of MRI and cognitive testing to evaluate changes in the brain and cognitive function that occur in subjects with ornithine transcarbamylase deficiency (OTCD) relative to healthy…
- Trial name
- NCT01569568
- Testing
- MRI scanning, Cognitive testing
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Andrea Gropman
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, Mitral Valve Regurgitation
Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (The COAPT Trial) and COAPT CAS
The purpose of the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) Trial is to confirm the safety and effectiveness of the MitraClip…
- Conditions
- Mitral Regurgitation, Mitral Valve Regurgitation, Treatment of Functional Mitral Regurgitation in Symptomatic Heart Failure Subjects, Heart Failure
- Trial name
- COAPT (NCT01626079)
- Testing
- MitraClip System
- Where
- 86 sites in United States, Canada
- Volunteers
- 776 people
- Sponsor
- Abbott Medical Devices
Functional Mitral Regurgitation, Degenerrative Mitral Regurgitation
MitraClip Russia Trial
The MitraClip System is the first commercially available catheter-based option for the treatment of MR. The MitraClip System was developed as an alternate percutaneous technology which may serve as a viable therapeutic option for…
- Trial name
- NCT04350372
- Testing
- MitraClip Procedure
- Where
- Russia
- Volunteers
- 16 people
- Sponsor
- Abbott Medical Devices
Healthy
Functional Effects of Botox on the Brain Using MRS and fMRI
The injection of BOTOX into peripheral muscles has been shown to have therapeutic effects in a growing number of indications including disorders involving skeletal muscle (e.g., strabismus, blepharospasm, cervical dystonia…
- Trial name
- NCT03373162
- Testing
- onabotulinumtoxinA
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- University of California, Irvine
Functional Mitral Regurgitation, Mitral Regurgitation
Edwards Cardioband System ACTIVE Pivotal Clinical Trial (ACTIVE)
To establish the safety and effectiveness of the Edwards Cardioband System in patients with functional mitral regurgitation (FMR).
- Conditions
- Functional Mitral Regurgitation, Mitral Regurgitation, Mitral Insufficiency
- Trial name
- ACTIVE (NCT03016975)
- Testing
- Edwards Cardioband System, Guideline Directed Medical Therapy
- Where
- 24 sites in United States
- Volunteers
- 12 people
- Sponsor
- Edwards Lifesciences
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
Molecular Mechanisms of Volume Overload-Aim 1(SCCOR in Cardiac Dysfunction and Disease)
The investigators hypothesize that beta-1 receptor blockade (ß1-RB) attenuates extracellular matrix (ECM) degradation and progressive adverse Left Ventricular (LV) remodeling and failure in the volume overload of mitral…
- Trial name
- P1A1 (NCT01052428)
- Testing
- metoprolol succinate (Toprol XL)
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Mitral Stenosis With Insufficiency, Functional Mitral Regurgitation
AVJ-514 Japan Trial
The objective of the study is to confirm the reproducibility of the evidence of safety and efficacy of AVJ-514 System technology in Japanese subjects who have been deemed difficult for mitral valve surgery by the local site heart…
- Conditions
- Mitral Stenosis With Insufficiency, Functional Mitral Regurgitation, Mitral Insufficiency, Mitral Valve Incompetence
- Trial name
- NCT02520310
- Testing
- AVJ-514
- Where
- 6 sites in Japan
- Volunteers
- 30 people
- Sponsor
- Abbott Medical Devices
Cardiomyopathy, Cardiovascular Diseases
Improving Mitral Repair for Functional Mitral Regurgitation
The investigators are interested in determining the best surgical technique to correct functional mitral regurgitation, as there is currently not one technique that is established to work better than the other.
- Conditions
- Cardiomyopathy, Cardiovascular Diseases, Congestive Heart Failure, Coronary Artery Disease
- Trial name
- IMPROVE-FMR (NCT03366649)
- Testing
- Undersizing Mitral Annuloplasty, Papillary Muscle Approximation
- Where
- 3 sites in United States
- Volunteers
- 34 people
- Sponsor
- Emory University
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
HIV Associated Neurocognitive Disorder
Study of Paroxetine and Fluconazole for the Treatment of HIV Associated Neurocognitive Disorder
The purpose of this study is to see if paroxetine and fluconazole are safe and effective as a treatment for problems with memory, concentration, thinking, and judgment in people who are infected with HIV.
- Trial name
- ParaFlu (NCT01354314)
- Testing
- Fluconazole, Paroxetine, Paroxetine and Fluconazole
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Johns Hopkins University
Brain Hypoxia
Metabolic Changes in the Activated Human Visual Cortex During Mild Hypoxia
The primary objective of this research is to measure changes in neurochemical concentrations during stimulation of the primary visual cortex, in both conditions of normoxia (normal oxygen availability) and induced mild hypoxia…
- Trial name
- NCT02482571
- Testing
- Mild Hypoxia
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- University of Minnesota
Functional Mitral Regurgitation
NHLBI DIR Transcatheter Mitral Cerclage Annuloplasty Early Feasibility Study
This research protocol tests a new technique and devices that we have developed to treat functional mitral valve regurgitation, called transcatheter mitral valve cerclage annuloplasty, otherwise known as "cerclage".
- Trial name
- NCT03929913
- Testing
- Transmural Systems Transcatheter Mitral Cerclage Annuloplasty (TMCA)
- Where
- 3 sites in United States
- Volunteers
- 19 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Autism Spectrum Disorder
Behavioral and Neural Response to Memantine in Adolescents With Autism Spectrum Disorder
This study is a 12-week, randomized-controlled trial of memantine hydrochloride (Namenda) for the treatment of social impairment in adolescents with autism spectrum disorder (ASD).
- Trial name
- NCT01972074
- Testing
- Memantine
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Mitral Valve Insufficiency, Mitral Valve Regurgitation
Pivotal Study of a Percutaneous Mitral Valve Repair System
EVEREST II Randomized Controlled Trial (RCT) is a prospective, multi-center, randomized study of the MitraClip® System in the treatment of mitral valve regurgitation, randomizing patients to MitraClip or mitral valve surgery.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation
- Trial name
- EVERESTIIRCT (NCT00209274)
- Testing
- Percutaneous mitral valve repair using MitraClip implant, Mitral valve repair or replacement surgery
- Where
- United States
- Volunteers
- 279 people
- Sponsor
- Abbott Medical Devices
Alcoholism
Ketogenic Diet (KD) in Alcoholism
Background: A ketogenic diet (KD) is high in fat and low in carbohydrates. Research has shown that a KD can lessen tremor in animals withdrawing from alcohol.
- Trial name
- NCT03255031
- Testing
- Ketogenic Diet (KD), Standard American (SA) Meals and Shakes
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)