Clinical trials: Degenerative Valve Disease
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.
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
Mitral Valve Regurgitation
CardiAQ-Edwards™ Transcatheter Mitral Valve Replacement (TMVR) Study
Clinical study to evaluate the safety and performance of the CardiAQ-Edwards™ Transcatheter Mitral Valve
- Trial name
- RELIEF (NCT02722551)
- Testing
- Transcatheter Mitral Valve Re-placement (TMVR) with the CardiAQ-Edwards™ Transcatheter Mitral Valve
- Where
- 15 sites in Canada, Denmark and 5 more
- Sponsor
- Edwards Lifesciences
Bioprosthesis Failure, Allograft
Comparative Analysis of Stented Biological Prosthesis Versus Aortic Allograft in Patients With Degenerative Aortic Valve Disease
The aim of the observational study is to compare safety, clinical efficacy and time-to-event survival in patients age of 60-74 years with degenerative aortic valve disease that underwent aortic valve replacement with either…
- Trial name
- BIOCHOICE (NCT07210541)
- Testing
- aortic valve/root replacement
- Volunteers
- 93 people
- Sponsor
- Chelyabinsk Regional Clinical Hospital
Aortic Valve Stenosis, Structural Valve Deterioration
Single Perclose Escalation Technique for Vascular Closure in TAVR
This study examines in the safety and efficacy of using a single Perclose escalation technique (SPET) using a single Perclose Proglide device to preclose and the need for a rescue device based on a control angiography at the end…
- Conditions
- Aortic Valve Stenosis, Structural Valve Deterioration, Structural Valve Degeneration
- Trial name
- NCT05836311
- Testing
- One Perclose Proglide Suture, Two Perclose Proglide Suture
- Where
- Spain
- Volunteers
- 300 people
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute
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
Safety and Performance Study of the NeoChord Device
The purpose of this study is to demonstrate the safety and performance of the NeoChord DS1000 Artificial Chordae Delivery System in implanting ePTFE sutures(s) as artificial neochordae in patients with mitral regurgitation.
- Trial name
- TACT (NCT01777815)
- Testing
- NeoChord DS1000 Artificial Chordae Delivery System
- Where
- 8 sites in Denmark, Germany and 2 more
- Volunteers
- 30 people
- Sponsor
- NeoChord
Stenoses, Aortic Valve, Aortic Insufficiency
Perceval Aortic Bioprostheses : Durability Study.
Aortic valve replacement is one of the most commonly performed procedures in adult cardiac surgery in France. Patients over the age of 65 most often receive a bioprosthetic aortic valve during an isolated aortic valve replacement…
- Conditions
- Stenoses, Aortic Valve, Aortic Insufficiency, Aortic Diseases
- Trial name
- NCT07116265
- Volunteers
- 192 people
- Sponsor
- University Hospital, Montpellier
Mitral Regurgitation
Early Surgery Versus Conventional Treatment for Asymptomatic Severe Mitral Regurgitation
The timing of surgical intervention in asymptomatic patients with severe degenerative mitral regurgitation (MR) remains controversial.
- Trial name
- NCT01703806
- Testing
- Early Surgery, Watchful Observation
- Where
- 2 sites in South Korea
- Volunteers
- 1,063 people
- Sponsor
- Asan Medical Center
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
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
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
Friedreich Ataxia, Cardiomyopathy, Secondary
Study of LX2006 Gene Therapy in Friedreich Ataxia Cardiomyopathy
The purpose of Study LX2006-03, a multicenter, Phase 2, open-label, randomized, controlled study, is to evaluate the efficacy and safety of LX2006 gene therapy in participants with Friedreich ataxia (FA) cardiomyopathy (CM).
- Trial name
- SUNRISE-FA 2 (NCT07721025)
- Testing
- LX2006, Usual Care
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Lexeo Therapeutics
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
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
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
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
Tricuspid Regurgitation
Edwards CLASP TR EFS
Early feasibility study to assess the safety and performance of the Edwards PASCAL Transcatheter Valve Repair System in tricuspid regurgitation
- Trial name
- CLASP TR EFS (NCT03745313)
- Testing
- Edwards PASCAL Transcatheter Valve Repair System
- Where
- 15 sites in United States
- Volunteers
- 65 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis
The Effect of Subclinical Leaflet Thrombosis and Prosthesis Type on Transcatheter Aortic Valve Degeneration (POPular PET TAVI)
A multicentre cross-sectional cohort study to assess the difference in bioprosthetic micro-calcification activity, detected with 18F-NaF PET-CT, as early marker of transcatheter valve degeneration, between patients with vs.
- Trial name
- NCT05758662
- Testing
- 18F-sodium fluoride Positron Emission Tomography (18F-NaF PET), Cardiac Computed Tomography (CT), Transthoracic Echocardiography (TTE)
- Where
- 4 sites in Denmark, Netherlands and 1 more
- Volunteers
- 180 people
- Sponsor
- St. Antonius Hospital
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.