Clinical trials: Severe Heart Valve Disease
Severe Aortic Stenosis, Valve-in-valve Procedures
A Clinical Trial Assessing the Safety and Effectiveness of the DurAVR® THV System
Prospective, randomized, controlled, multicenter, international study. Up to 1054 subjects with a severe native calcific aortic stenosis who are determined by the local Heart Team to have an indication for Transcatheter Aortic…
- Trial name
- PARADIGM (NCT07194265)
- Testing
- TAVR with DurAVR® THV, TAVR with SAPIEN THV series or the Evolut THV series
- Where
- Denmark
- Volunteers
- 1,650 people
- Sponsor
- Anteris Technologies Ltd.
Severe Mitral Valve Regurgitation, Severe Mitral Valve Stenosis
The Feasibility Study of Polymer Artificial Heart Valve for the Treatment the Mitral Valve Disease.
The study aims to evaluate the feasibility and safety of polymer artificial heart valve designed and developed by Shanghai HeartEpoch Medical technology Co. Ltd. for the treatment of the mitral valve diseases.
- Trial name
- HeartEpoch (NCT07243184)
- Testing
- mitral valve replacement
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Shanghai HeartEpoch Medical Technology Co., Ltd
Severe Aortic Stenosis
Safety and Efficacy of SYM-SV/DS-002 in Patients With Severe Aortic Stenosis
Safety and Efficacy of SYM-SV/DS-002 in Patients with Severe Aortic Stenosis
- Trial name
- NCT03004599
- Testing
- SYM-SV-002 Aortic Bioprosthesis and SYM-DS-002 Transfemoral Delivery System
- Where
- 5 sites in Japan
- Volunteers
- 11 people
- Sponsor
- Medico's Hirata Inc.
Mitral Regurgitation
Dutch-AMR: Early Mitral Valve Repair Versus Watchful Waiting in Asymptomatic Patients With Severe Mitral Regurgitation
Rationale: Severe asymptomatic organic Mitral Valve (MV) regurgitation with preserved left ventricular (LV) function is a challenging clinical entity as data on the recommended treatment strategy for these patients are scarce and…
- Trial name
- Dutch-AMR (NCT03975998)
- Testing
- Mitral valve repair
- Where
- 6 sites in Netherlands
- Volunteers
- 500 people
- Sponsor
- UMC Utrecht
Mitral Regurgitation
Prospective Treatment Algorithm Guiding Repair of Severe Ischemic Mitral Regurgitation
Ischemic mitral regurgitation is a disease where the mitral valve is regurgitant, or leaking, as a result of changes in the muscle of the heart caused by coronary artery disease Ischemic mitral regurgitation, or IMR, is normally…
- Trial name
- NCT03292497
- Testing
- Treatment Algorithm, No Treatment Algorithm
- Where
- Canada
- Volunteers
- 110 people
- Sponsor
- Ottawa Heart Institute Research Corporation
Mitral Valve Insufficiency, Coronary Artery Disease
Long Term Follow Up for CTSN Mitral Valve Repair Studies
This study is a continuation of two previous studies --- the Severe Ischemic Mitral Regurgitation (SMR) Trial (NCT00807040) and the Moderate Ischemic Mitral regurgitation (MMR) Trial (NCT00806988) --- to learn more about…
- Trial name
- NCT03066050
- Testing
- MV Repair, MV Replacement, CABG
- Where
- 24 sites in United States, Canada
- Volunteers
- 368 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Severe Tricuspid Regurgitation
Treatment of Severe Secondary TRIcuspid Regurgitation in Patients With Advance Heart Failure With CAval Vein Implantation of the Edwards Sapien XT VALve (TRICAVAL)
The purpose of this study is to assess the efficacy and safety of implanting an Edwards Sapien XT Valve into the vena cava inferior (VCI; between right atrium and the hepatic vein) on clinical variables, exercise tolerance and…
- Trial name
- NCT02387697
- Testing
- Edwards Sapien XT Valve
- Where
- Germany
- Volunteers
- 28 people
- Sponsor
- Charite University, Berlin, Germany
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
Severe Tricuspid Valve Regurgitation
Patients With Severe TrIcuspid Regurgitation After triCvALve System Implantation
International Registry to collect patients with severe TR undergoing TricValve implantation from multiple Italian and European centers, aimed at: Assessing the effect of TricValve implantation on cardiovascular and all-cause…
- Trial name
- CRITICAL (NCT05820516)
- Testing
- TricValve implantation
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Azienda Ospedaliero, Universitaria Pisana
Severe Mitral Valve Regurgitation (Disorder)
Transcatheter Versus Standard Surgical Mitral Valve Operation for Secondary Mitral Regurgitation
The mechanical intervention is treating secondary mitral regurgitation (SMR) which may be performed using the standard open surgical approach or transcatheter edge to edge repair (TEER).
- Trial name
- TEERMISO (NCT05090540)
- Testing
- Trancatheter Edge to Edge Repair, Mitral Valve Replacement, Restrictive Mitral Annuloplastie
- Where
- 2 sites in France
- Volunteers
- 600 people
- Sponsor
- Centre Cardiologique du Nord
Aortic Valve Stenosis, Heart Failure
ENAVOgliflozin Outcome Trial in Patients With Severe Aortic Stenosis After Transcatheter Aortic Valve Replacement
The goal of this trial is to to determine whether use of a novel SGLT2 inhibitor, Enavogliflozin 0.3 mg once daily is superior to placebo, when added to standard-of-care, in reducing the composite of major cardiovascular events…
- Trial name
- ENAVO-TAVR (NCT05672836)
- Testing
- Enavogliflozin, Standard-of-Care
- Where
- 31 sites in South Korea
- Volunteers
- 1,040 people
- Sponsor
- Duk-Woo Park, MD
Mitral Valve Disease
Mitral Implantation of TRAnscatheter vaLves
The purpose of this trial is to establish the safety and feasibility of the Edwards SAPIEN XT™and SAPIEN 3™ device and delivery systems in patients with severe symptomatic calcific mitral valve disease with severe mitral annular…
- Trial name
- MITRAL (NCT02370511)
- Testing
- Transcatheter Mitral Valve Replacement
- Where
- 15 sites in United States
- Volunteers
- 91 people
- Sponsor
- Mayra Guerrero
Aortic Valve Stenosis
The SAPIEN 3 Ultra System in Intermediate Risk Patients With Symptomatic, Severe Aortic Stenosis
This study will confirm the procedural safety and performance of the SAPIEN 3 Ultra System in subjects with severe, calcific AS who are at intermediate operative risk for standard aortic valve replacement.
- Trial name
- NCT03471065
- Testing
- SAPIEN 3 Ultra Delivery System with the SAPIEN 3 Ultra THV
- Where
- 6 sites in Canada, United Kingdom
- Volunteers
- 100 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis, Heart Failure
The Effectiveness and Safety of Levosimendan in Patients With Severe Aortic Stenosis and Heart Failure Undergoing Transcatheter Aortic Valve Replacement
A study to evaluate the effectiveness and safety of levosimendan compared with placebo in subjects with severe aortic stenosis and heart failure undergoing transcatheter aortic valve replacement
- Conditions
- Aortic Valve Stenosis, Heart Failure, Inotropic Agents, Safety Issues
- Trial name
- NCT04573049
- Testing
- Levosimendan
- Where
- China
- Volunteers
- 124 people
- Sponsor
- China National Center for Cardiovascular Diseases
Symptomatic Severe Native Aortic Stenosis, Aortic Stenosis
STAR Trial (Siegel Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis)
To evaluate the safety and efficacy of Siegel™ TAVR System in the treatment of subjects with symptomatic severe native aortic stenosis.
- Trial name
- NCT07278310
- Testing
- TAVR Device, Siegel TAVR Device
- Where
- United States
- Volunteers
- 1,025 people
- Sponsor
- MiRus
Severe Aortic Stenosis, Aortic Regurgitation
Evaluate the Transcatheter Artificial Aortic Valve and Transcatheter Artificial Heart Values Delivery System
The purpose of this study is to demonstrate that transcatheter artificial aortic valve and transcatheter artificial heart values delivery system is associated with a reduction of all-cause mortality in severe aortic stenosis or…
- Trial name
- TAVI (NCT03788590)
- Testing
- Jenscare TAVI
- Volunteers
- 133 people
- Sponsor
- Ningbo Jenscare Biotechnology Co., Ltd.
Severe Native Calcific Aortic Stenosis, Symptomatic Heart Disease Due to Severe Native Calcific Aortic Stenosis
Validation Of anatomY-specific Aortic Valve Implantation Guided by Software Using EncantoR
VOYAGER CE Clinical Study using the Encantor TAVI System.
- Trial name
- VOYAGER CE (NCT07696182)
- Testing
- Prospective, single-arm, multi-center study.
- Volunteers
- 150 people
- Sponsor
- Abbott Medical Devices
Severe Aortic Stenosis, TAVI(Transcatheter Aortic Valve Implantation)
Observational Study Relating to the Long-term Follow-up of Patients with Severe Aortic Stenosis Evaluated for Percutaneous Aortic Valve Replacement (TAVI).
All patients with severe aortic stenosis undergoing evaluation for TAVI are routinely subjected to a series of assessments: Pre-implantation: thoraco-abdominal CT angiography, coronary angiography, echocardiography, clinical…
- Trial name
- ROARING-TAVI (NCT06679517)
- Testing
- TAVI
- Where
- Italy
- Volunteers
- 600 people
- Sponsor
- University Hospital of Ferrara
Severe Aortic Valve Stenosis, Cardiovascular Diseases
Pilot Study to Evaluate a Noninvasive Electrocardiographic Monitoring Strategy Associated With Early Discharge in Patients With Conduction Disorders Following TAVI Implantation (IMPROVE Study)
Study to evaluate the efficacy and safety of a non-invasive electrocardiographic monitoring strategy associated with early discharge in patients with conduction disorder after transfemoral TAVI implantation, and its potential…
- Trial name
- IMPROVE (NCT07456280)
- Testing
- Standard care, PhysioMem PM 100 4G ambulatory monitoring system
- Where
- Spain
- Volunteers
- 100 people
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute
Severe Aortic Stenosis
Transfemoral TAVI With or Without Coronary Angiogram in Patients With Severe Aortic Stenosis (PURE TAVI)
This study will be conducted in patients with severe aortic stenosis who are referred for transcatheter aortic valve implantation (TAVI). TAVI is the recommended treatment for severe aortic stenosis.
- Trial name
- PURETAVI (NCT06898086)
- Testing
- Transcatheter aortic valve implantation
- Where
- 23 sites in Austria, Czechia and 5 more
- Volunteers
- 620 people
- Sponsor
- Rede Optimus Hospitalar SA