Clinical trials: Heart Valve Diseases
Cardiac Amyloidosis, Aortic Stenosis
Aortic Stenosis and Cardiac Amyloidosis
The dual pathology of aortic stenosis (AS) and cardiac amyloidosis (CA) is increasingly recognized. Even tough efforts have been undertaken to bring cohorts together, the largest cohort of AS-ATTR to date is <50 patients.
- Trial name
- NCT06129331
- Testing
- Amyloid-specific treatment, No amyloid-specific treatment
- Where
- 2 sites in Austria, United Kingdom
- Volunteers
- 300 people
- Sponsor
- Medical University of Vienna
Tricuspid Regurgitation (TR), Valvular Heart Diseases
Robotic Transjugular Transcatheter Tricuspid Valve Replacement
Valvular heart disease (VHD), caused by abnormalities in heart valves, can lead to severe complications such as heart failure and death, with approximately 220 million affected patients worldwide.
- Conditions
- Tricuspid Regurgitation (TR), Valvular Heart Diseases, Transcatheter Valve Replacement
- Trial name
- Robotic Lux (NCT07516145)
- Testing
- Transcatheter tricuspid valve replacement
- Where
- Hong Kong
- Volunteers
- 10 people
- Sponsor
- Prince of Wales Hospital, Shatin, Hong Kong
Congenital Mitral Insufficiency
Study of Innovative Drug Strategies in Improving Left Ventricular Function After Mitral Repair
The goal of this observational study is to compare the safety and effectiveness of a modified drug therapy with traditional drug therapy in pediatric patients after mitral repair.
- Trial name
- NCT06039592
- Testing
- Captopril Tablets, Metoprolol Oral Tablet, Spironolactone Tablets
- Where
- China
- Volunteers
- 164 people
- Sponsor
- China National Center for Cardiovascular Diseases
Aortic Valve Stenosis
Venus-Vitae Pivotal Study Smart-Align Study
The purpose is to evaluate the safety, effectiveness and performance of Venus-Vitae Transcatheter Heart Valve System in patients with severe aortic stenosis.
- Trial name
- NCT05991271
- Testing
- Venus-Vitae Transcatheter Heart Valve System
- Volunteers
- 150 people
- Sponsor
- Venus MedTech (HangZhou) Inc.
Valvular Diseases
Effectiveness of Remote Cardiac Rehab After Surgery for Acquired Heart Valve Disease
The goal of this clinical trial is to learn if home-based cardiac rehabilitation using remote monitoring devices improves exercise capacity in patients after surgery for acquired heart valve diseases.
- Trial name
- NCT06984172
- Testing
- Remote cardiac rehabilitation, Facility-based cardiac rehabilitation
- Where
- Vietnam
- Volunteers
- 44 people
- Sponsor
- Hanoi Medical University
Atrial Fibrillation
Study to Learn More About the Benefits and Side-effects of Drugs Rivaroxaban and Apixaban Compared to the Drug Warfarin for Stroke Prevention in Patients With Rapid and Irregular Heartbeat Which is Not Due to a Heart-valve Fault (Non-valvular Atrial Fibrillation) in the UK Routine Clinical Practice
This population-based study will identify patients with rapid and irregular heartbeat which is not due to a fault with the heart valves (non-valvular atrial fibrillation) who initiate rivaroxaban, apixaban or warfarin as…
- Trial name
- SiERRA UK (NCT03847181)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939), Apixaban (Eliquis), Warfarin
- Where
- United Kingdom
- Volunteers
- 45,164 people
- Sponsor
- Bayer
Heart Failure, Valvular Heart Diseases
Observational Study to Validate a Family Physician Echocardiography Training Programme
Observational Study on the Validation of Family Doctors' Training in Echocardiography The Catalan Society of Family and Community Medicine (CAMFiC) developed a structured training program for Family Physicians in focused cardiac…
- Conditions
- Heart Failure, Valvular Heart Diseases, Atrial Fibrillation (AF), Arterial Hypertension
- Trial name
- HEART-CAMFiC (NCT07339007)
- Testing
- Cohort of GPs: Training program, Cohort of patients
- Where
- Spain
- Volunteers
- 500 people
- Sponsor
- Societat Catalana de Medicina Familiar i Comunitària, Assoc. (CAMFiC)
Severe Symptomatic Aortic Stenosis
Change in Coronary Microcirculation and FFR After TAVI in Patients With Cardiovascular Comorbidities
Change in coronary microcirculation and Fractional Flow Reserve after Transcatheter Aortic Valve Implantation in patients with concomitant coronary artery disease and severe aortic stenosis.
- Trial name
- NCT04663334
- Testing
- inverse myocardial remodeling
- Where
- France
- Volunteers
- 29 people
- Sponsor
- Nantes University Hospital
Bicuspid Aortic Valve (BAV), Aortic Aneurysm
Research on Aneurysm Growth Prediction in Vascular Dilation Caused by Bicuspid Aortic Valve Based on VDM and CFD
Bicuspid aortic valve (BAV) is the most common congenital valvular malformation, characterized by heterogeneous phenotypic subtypes that predispose patients to secondary aortic pathologies, including valvular dysfunction and…
- Conditions
- Bicuspid Aortic Valve (BAV), Aortic Aneurysm, TAVR
- Trial name
- NCT07782918
- Testing
- Transcatheter Aortic Valve Replacement
- Where
- 2 sites in China
- Volunteers
- 1,000 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
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 Disease
EXPLORE MRace (GE): Early Feasibility Experience of Posterior Leaflet Restoration to Reduce Mitral Regurgitation Using the MRace Implant
An early feasibility study to evaluate the safety and feasibility of the MRace Implant and Delivery System to treat severe mitral regurgitation and to gather preliminary data on its performance thereby providing guidance for…
- Trial name
- EXPLORE_MRace (NCT07796659)
- Testing
- Transcatheter mitral valve repair (MRace Implant and Delivery System)
- Where
- 4 sites in Georgia
- Volunteers
- 100 people
- Sponsor
- Polares Medical SA
Aortic Stenosis
CAN3T - Canadian TAVI Triage Tool
The goal of this trial is to see if a tool that may reduce wait times will reduce bad outcomes in participants on the TAVI waitlist.
- Trial name
- CAN3T (NCT06551610)
- Testing
- Triage Tool
- Volunteers
- 5,060 people
- Sponsor
- Sunnybrook Health Sciences Centre
Aortic Stenosis, Severe
ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve
The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS).
- Trial name
- NCT05172960
- Testing
- SAPIEN X4 THV, SAPIEN X4S
- Where
- 65 sites in United States, Australia and 2 more
- Volunteers
- 1,234 people
- Sponsor
- Edwards Lifesciences
Transcatheter Aortic Valve Implantation
Investigation of the ALLEGRA THV System With a New Delivery System in Patients With Aortic Stenosis or Failed Surgical Bioprosthesis
The EMPIRE study confirms the technical performance of the new IMPERIA Delivery System and evaluates the safety and efficacy of the entire ALLEGRA THV System.
- Trial name
- EMPIRE (NCT05478161)
- Testing
- (ALLEGRA Transcatheter Heart Valve) TAVI in severe calcified aortic stenosis or in failed surgical aortic bioprosthesis
- Where
- 11 sites in Germany, Netherlands and 1 more
- Volunteers
- 137 people
- Sponsor
- NVT GmbH
Heart Failure With Reduced Ejection Fraction, Heart Failure
STEPwise De-escalation and Optimizing Withdrawal of ARNI and SGLT2i in Normalized Heart Failure
This is a multicenter, randomized, open-label pilot study to evaluate whether stepwise withdrawal of two heart failure medications-angiotensin receptor-neprilysin inhibitor (ARNI) and sodium-glucose cotransporter-2 inhibitor…
- Conditions
- Heart Failure With Reduced Ejection Fraction, Heart Failure, Ventricular Dysfunction, Left
- Trial name
- STEP-DOWN HF (NCT07631156)
- Testing
- Stepwise Withdrawal of ARNI and SGLT2i, Continued Guideline-Directed Medical Therapy
- Where
- 5 sites in South Korea
- Volunteers
- 80 people
- Sponsor
- Kyungsub Song
Severe Aortic Stenosis
Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement
The purpose of the study is to evaluate the safety and efficacy of the Medtronic CoreValve® System in the treatment of symptomatic severe aortic stenosis in subjects who have a predicted high risk for aortic valve surgery and/or…
- Trial name
- NCT01240902
- Testing
- Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI), Surgical Aortic Valve Replacement (SAVR)
- Where
- 45 sites in United States
- Volunteers
- 1,453 people
- Sponsor
- Medtronic Cardiovascular
Heart Failure, Mitral Regurgitation
Montreal Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device
Reduction in mitral regurgitation due to safe placement of a PTMA device in the coronary sinus.
- Trial name
- PTOLEMY (NCT00571610)
- Testing
- PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant
- Where
- Canada
- Volunteers
- 5 people
- Sponsor
- Viacor
Severe Tricuspid Valve Regurgitation (Disorder)
Rhythm Control and Potential Early Surgery for Tricuspid Regurgitation
The purpose of this study is to understand the clinical impact of non-surgical and surgical treatment in atrial fibrillation induced tricuspid regurgitation (AFTR).
- Trial name
- NCT05045079
- Testing
- Inferior Vena Caval (IVC) Occlusion maneuver
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Mayo Clinic
Aortic Valve Stenosis
Anticoagulant Versus Dual Antiplatelet Therapy for Preventing Leaflet Thrombosis and Cerebral Embolization After Transcatheter Aortic Valve Replacement
This trial is to compare the efficacy of NOAC(Novel Oral Anticoagulants) with edoxaban vs. dual antiplatelet therapy (DAPT) for prevention of leaflet thrombosis (documented by cardiac CT imaging) and cerebral embolization…
- Trial name
- ADAPT-TAVR (NCT03284827)
- Testing
- NOAC, DAPT
- Where
- 5 sites in Hong Kong, South Korea and 1 more
- Volunteers
- 235 people
- Sponsor
- Duk-Woo Park, MD
Hypertrophic Cardiomyopathy
3D Non-invasive Myocardial Electrical Propagation Mapping as a New Tool to Predict Sudden Death Risk in Patients With Hypertrophic Cardiomyopathy
Hypertrophic cardiomyopathy (HCM) is very common. The thickened heart muscle can disrupt the normal functioning of the heart's electrical system, resulting in fast or irregular heartbeats.
- Trial name
- 3D-CMH (NCT03550573)
- Testing
- CardioInsight™ Noninvasive 3D Mapping System
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Hospices Civils de Lyon
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