Clinical trials: Degenerative Heart Valve Disease
Mitral Valve Regurgitation (Degenerative or Functional)
Mitral Annular Repair With the CathHELIX™ Transcatheter System in Subjects With FMR
Patients with functional mitral regurgitation classified as moderate to severe (3+) or severe (4+) that are symptomatic (NYHA Class II-IV) will be evaluated for treatment using the CathHELIX Transcatheter Mitral Annuloplasty…
- Trial name
- MARCH (NCT07188233)
- Testing
- Transcatheter Mitral Valve Repair
- Where
- 2 sites in Georgia, Lithuania
- Volunteers
- 5 people
- Sponsor
- HVR Cardio Oy
Mitral Valve Regurgitation (Degenerative or Functional)
TVMR With the Innovalve System Trial - First In Human Israel
Study to evaluate the safety and performance of the Innovalve mitral valve replacement system
- Trial name
- TWIST-FIHIL (NCT05688514)
- Testing
- Innovalve MR system
- Where
- Israel
- Volunteers
- 1 people
- Sponsor
- Edwards Lifesciences
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
Mitral Valve Repair, Mitral Regurgitation
ChordArt System for Mitral Regurgitation
The ChordArt System is a novel catheter based technology for mitral chordal replacement that enables controlled implantation of artificial mitral chords to treat mitral regurgitation with a minimally invasive approach.
- Conditions
- Mitral Valve Repair, Mitral Regurgitation, Mitral Valve Insufficiency
- Trial name
- CHAGALL (NCT03581656)
- Testing
- ChordArt System
- Where
- Lithuania
- Volunteers
- 5 people
- Sponsor
- CoreMedic GmbH
Mitral Regurgitation
Anchord Mitral Chordal Repair System - FIH
The goal of this clinical trial is to generate initial human clinical experience and evaluate procedural feasibility, device deployment, and early safety under controlled First-In-Human conditions for the Anchord Mitral Chordal…
- Trial name
- NCT07671820
- Testing
- Anchord device implantation
- Volunteers
- 5 people
- Sponsor
- Lifecord Otd
Calcific Aortic Valve Disease, Aortic Valve Stenosis
Serum and Cellular Biomarkers for Aortic Valve Stenosis
AthenaValve aims to develop and initial validate a novel serum diagnostic kit, for the assessment of severity and prognosis of progression of aortic valve stenosis (AS, a devastating disease without early diagnosis and medical…
- Conditions
- Calcific Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve, Calcification of
- Trial name
- AthenaValve (NCT04312139)
- Testing
- Echocardiography, Computerized Tomography Aortic Valve Calcium Score, Untargeted LC/MS and LC-MS/MS
- Where
- 2 sites in Greece
- Volunteers
- 280 people
- Sponsor
- National and Kapodistrian University of Athens
Spinal Muscular Atrophy, Fragile X Syndrome
Early Check: Expanded Screening in Newborns
Early Check provides voluntary screening of newborns for a selected panel of conditions. The study has three main objectives: 1) develop and implement an approach to identify affected infants, 2) address the impact on infants and…
- Conditions
- Spinal Muscular Atrophy, Fragile X Syndrome, Fragile X - Premutation, Duchenne Muscular Dystrophy
- Trial name
- NCT03655223
- Testing
- Confirmatory Testing
- Where
- United States
- Volunteers
- 30,000 people, healthy volunteers welcome
- Sponsor
- RTI International
Aortic Stenosis, Imaging
Mechanisms Of Disease Progression in Aortic Stenosis - the MODAS Study
Biomarkers and mechanisms in the progression of aortic valve stenosis are sometimes not sufficiently understood. The current project will take into account image morphological and immunological aspects that predict the…
- Conditions
- Aortic Stenosis, Imaging, Pathogenesis, Disease Progression
- Trial name
- NCT05851209
- Where
- 3 sites in Germany
- Volunteers
- 938 people
- Sponsor
- Heinrich-Heine University, Duesseldorf
Mitral Regurgitation
A Pan-Canadian, Retrospective Evaluation of MitraClip Safety and Efficacy
The PREMISE Registry is a retrospective, observational study that will evaluate the efficacy and safety of the MitraClip in real-world Canadian practice.
- Trial name
- PREMISE (NCT03592043)
- Testing
- MitraClip
- Where
- Canada
- Volunteers
- 1,191 people
- Sponsor
- Population Health Research Institute
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
Mitral Regurgitation
The Effects of Degenerative Mitral Regurgitation on Cardiac Structure and Function, Symptoms, and Exercise Capacity
Current American College of Cardiology/American Heart Association guidelines recommend that patients with severe degenerative mitral regurgitation be considered for mitral valve surgery.
- Trial name
- NCT04051411
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Atlantic Health System
Mitral Valve Insufficiency
High and Intermediate Risk Degenerative Mitral Regurgitation Treatment: A Trial Comparing MitraClip® to Surgical Therapy
The study is comparing MitraClip® to Surgical therapy in high and intermediate risk patients, who should be older than 18 years, and shall evaluate safety and efficacy of MitraClip® vs.
- Trial name
- HiRiDe (NCT02534155)
- Testing
- MitraClip®, Mitral valve Surgery
- Where
- 12 sites in Germany, Italy and 1 more
- Volunteers
- 294 people
- Sponsor
- University of Zurich
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.
Degenerative Aortic Valve Disease, Aortic Stenosis
Transcatheter Aortic Valve Replacement Versu Surgical Aortix Valve Replacement for Treating Elderly Patients With Severe Aortic Stenosis and Small Aortic Annuli: A Prospective Randomized Study The VIVA Trial
To date, no formal, randomized, prospective, head-to-head comparisons of surgical aortic valve replacement (SAVR) versus transcatheter aortic valve replacement (TAVR) have been undertaken in the severe aortic stenosis (AS)…
- Conditions
- Degenerative Aortic Valve Disease, Aortic Stenosis, Aortic Regurgitation
- Trial name
- NCT03383445
- Testing
- Edwards, CoreValve, Acurate neo
- Where
- Canada
- Volunteers
- 300 people
- Sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Valve Heart Disease
Balloon vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis
Transcatheter aortic valve implantation (TAVI) serves a growing spectrum of patients with symptomatic severe aortic stenosis (AS). Approximately 80% of surgical aortic valve replacements are performed using a bioprosthesis.
- Trial name
- BASELINE (NCT04843072)
- Testing
- EVOLUT R/PRO/PRO+/FX bioprosthesis, Edwards Sapien S3/Ultra bioprosthesis, MYVAL/Octacor/Octapro bioprosthesis
- Where
- 14 sites in United States, Austria and 10 more
- Volunteers
- 600 people
- Sponsor
- Erasmus Medical Center
Tricuspid Valve Regurgitation, Heart Valve Diseases
2019-06 TRISCEND Study
Prospective, multi-center study to assess safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System
- Conditions
- Tricuspid Valve Regurgitation, Heart Valve Diseases, Cardiovascular Diseases
- Trial name
- NCT04221490
- Testing
- Transcatheter Tricuspid Valve Replacement
- Where
- 20 sites in United States, Canada and 2 more
- Volunteers
- 228 people
- Sponsor
- Edwards Lifesciences
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
Aortic Stenosis, Hypo-attenuated Leaflet Thickening
The HALT Biomarker Study
The purpose of the HALT Biomarkers study are to identify a panel of circulating proteins that discriminates between patients with and without Hypo-Attenuated Leaflet Thickening (HALT) and can be used to supplement the diagnosis…
- Conditions
- Aortic Stenosis, Hypo-attenuated Leaflet Thickening, Bioprosthetic Valve Degeneration
- Trial name
- HALT (NCT04552275)
- Testing
- Proteomics Analysis
- Where
- 3 sites in United States
- Volunteers
- 300 people
- Sponsor
- Massachusetts General Hospital
Heart Valve Diseases
Effect of Remote Ischemia Preconditioning on Myocardial Injury in Patients Undergoing Heart Valve Surgery
Remote ischaemic preconditioning has shown its cardiac protective effect during heart surgery including coronary artery bypass graft surgery, congenital heart disease and aneurysm.
- Trial name
- NCT01175681
- Testing
- remote ischaemic preconditioning
- Where
- China
- Volunteers
- 73 people
- Sponsor
- Sun Yat-sen University
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