Clinical trials: Valve Replacement
Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR)
ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent
To demonstrate the safety and effectiveness of the Edwards Alterra Adaptive Prestent in conjunction with the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow…
- Conditions
- Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR), Tetralogy of Fallot, Congenital Heart Disease
- Trial name
- NCT03130777
- Testing
- Edwards Alterra Adaptive Prestent with SAPIEN 3 THV
- Where
- 14 sites in United States
- Volunteers
- 86 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis and/or Insufficiency, Hypoattenuated Leaflet Thickening
SYMmetric Valve fraME Expansion To Reduce hYpoattenuated Leaflet Thickening After Balloon-expandable TAVI: the SYMMETRY Trial
Rationale: Transcatheter aortic valve implantation (TAVI) has become the standard of care for aortic stenosis across all surgical risk categories, including low-risk, younger patients (≥70 years).
- Conditions
- Aortic Valve Stenosis and/or Insufficiency, Hypoattenuated Leaflet Thickening, Valve Expansion, Transcatheter Aortic Valve Replacement
- Trial name
- SYMMETRY (NCT07872020)
- Testing
- Double-TAP post-dilatation
- Where
- 5 sites in Germany, Netherlands
- Volunteers
- 422 people
- Sponsor
- Erasmus Medical Center
Surgical Valve Replacement, Dental
Impact of Preoperative Dental Screening in Reducing Infective Endocarditis Risk in Surgical Valve Replacement Patients
In Odense University Hospital preoperative dental screening (PDS) protocol for patients treated with surgical valve replacement was changed from mandatory to targeted PDS to from march 2024.
- Conditions
- Surgical Valve Replacement, Dental, Endocarditis
- Trial name
- DENSVAR (NCT06403839)
- Testing
- No preoperative dental screening
- Where
- Denmark
- Volunteers
- 1,000 people
- Sponsor
- Odense University Hospital
Aortic Valve Stenosis and Insufficiency, Coronary Artery Disease(CAD)
Assessment of Coronary Artery Disease Before Transcatheter Aortic Valve Replacement: A Randomized, Multicenter, Non-Inferiority Trial
The goal of this clinical trial is to determine whether a non-invasive coronary assessment strategy using photon-counting detector computed tomography (PCD-CT) is non-inferior to invasive coronary angiography (ICA) for evaluating…
- Conditions
- Aortic Valve Stenosis and Insufficiency, Coronary Artery Disease(CAD), Transcatheter Aortic Valve Replacement (TAVR)
- Trial name
- TAVR-CT (NCT07107568)
- Testing
- Standard Invasive Coronary Angiography, PCD-CT-Guided Diagnostic Strategy
- Where
- 2 sites in Austria
- Volunteers
- 700 people
- Sponsor
- Medical University Innsbruck
Aortic Valve Replacement
INSPIRIS China PMCF Study
The objective of this post-market trial is to evaluate long term safety and performance of the Edwards Lifesciences INSPIRIS RESILIA aortic valve in Chinese patients in a real-world clinical setting.
- Trial name
- INSPIRIS China (NCT05404880)
- Testing
- EDWARDS INSPIRIS RESILIA Aortic Valve
- Where
- 12 sites in China
- Volunteers
- 255 people
- Sponsor
- Edwards Lifesciences
Ethics, Cardiac Rehabilitation
The Role of 4 Different Consent Approaches on a Pilot Study to Increase Cardiac Rehabilitation Attendance
Cardiac Rehabilitation is a lifestyle and exercise program for patients with heart disease. Cardiac Rehabilitation is strongly recommended in guidelines, but only 30% of eligible patients attend.
- Conditions
- Ethics, Cardiac Rehabilitation, Coronary Heart Disease (CHD), Heart Failure
- Trial name
- MOST-CR (NCT07123480)
- Testing
- Usual Care Group, More Support and Tools
- Where
- United States
- Volunteers
- 160 people
- Sponsor
- Baystate Medical Center
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
Bleeding Post-mechanical Valve Replacement, Thromboembolism Post-mechanical Valve Replacement
Low INR to Minimize Bleeding With Mechanical Valves Trial
This study evaluates the use of a lower INR target (1.5 to 2.5) in patients with a mechanical bileaflet heart valve in the aortic position.
- Trial name
- LIMIT (NCT03636295)
- Testing
- Warfarin
- Where
- 45 sites in Belgium, Botswana and 16 more
- Volunteers
- 2,625 people
- Sponsor
- Population Health Research Institute
Mitral Regurgitation, Mitral Stenosis
Abbott Cephea Mitral Valve Disease Registry
The objective of this registry is to gather clinical data on symptomatic patients with mitral valve disease, including patients with mitral regurgitation, mitral stenosis, and mixed mitral valve disease.
- Conditions
- Mitral Regurgitation, Mitral Stenosis, Mitral Valve Disease, Mitral Valve (MV) Regurgitation
- Trial name
- NCT07069673
- Where
- 24 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Abbott Medical Devices
Stellate Ganglion Block, Heart Valve Replacement (Mechanical or Biological With AF)
Effect of Ultrasound-guided Left Stellate Ganglion Block on Rapid Recovery of Patients Undergoing Cardiac Valve Replacement and Its Mechanism
In this study, Valve replacement patients undergoing cardiopulmonary bypass were randomly divided into control group and experimental group (SGB Group) , main outcome measures: postoperative complications (pulmonary infection…
- Trial name
- NCT05587023
- Testing
- stellate ganglion block
- Where
- China
- Volunteers
- 62 people
- Sponsor
- Zhonghua Chen,MD
Aortic Valve Replacement
INSPIRIS RESILIA Aortic Valve, Valve-in-Valve Surveillance Study
The primary objective of the INSPIRIS RESILIA Aortic Valve-in-valve (ViV) Surveillance Study ("the Study") is to capture Adverse Event information and valve measurement data from dysfunctional INSPIRIS RESILIA aortic valves…
- Trial name
- INVIVITY (NCT04902053)
- Testing
- Subjects previously implanted with INSPIRIS RESILIA Model 11500A and are undergoing planned valve-in-valve treatment.
- Where
- 7 sites in United States
- Volunteers
- 50 people
- Sponsor
- Edwards Lifesciences
Acute Myocardial Infarction (AMI), Percutaneous Coronary Intervention (PCI)
BRIDGE Trial: Embedding Consumer-grade mHealth Technologies Into Cardiac Rehabilitation
The purpose of the BRIDGE study is to learn whether supplementing traditional center-based cardiac rehabilitation (CBCR) with a mobile health technology intervention can help patients monitor their health, stay engaged in healthy…
- Conditions
- Acute Myocardial Infarction (AMI), Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Graft Surgery (CABG), Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)
- Trial name
- BRIDGE (NCT07741396)
- Testing
- CBCR, BRIDGE mHealth intervention
- Volunteers
- 30 people
- Sponsor
- University of Illinois at Chicago
Transcatheter Aortic Valve Replacement (TAVR), Aortic-Stenosis
Prospective, Long-term Evaluation of the SAPIEN 3 Ultra RESILIA Valve
Evaluation of clinical outcomes and valve performance of the SAPIEN 3 Ultra Resilia (S3UR) valve over 10 years.
- Conditions
- Transcatheter Aortic Valve Replacement (TAVR), Aortic-Stenosis, Aortic Insufficiency, Degenerative Valve Disease
- Trial name
- RESOUND-EU (NCT06953206)
- Testing
- Transcatheter aortic valve (S3UR) replacement (TAVR)
- Where
- Germany
- Volunteers
- 500 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
Transcatheter Aortic Valve Replacement (TAVR), Left Ventricular Hypertrophy
Angiotensin Receptor Blocker After TAVR in Severe Aortic Stenosis With Left Ventricular Hypertrophy (ARBITAR)
This is a multicenter, prospective, open-label, randomized, investigator-initiated trial evaluating whether angiotensin receptor blocker (ARB) therapy improves clinical outcomes in patients with severe aortic stenosis (AS) and…
- Conditions
- Transcatheter Aortic Valve Replacement (TAVR), Left Ventricular Hypertrophy, Severe Aortic Stenosis
- Trial name
- ARBITAR (NCT07735130)
- Testing
- Angiotensin Receptor Blocker (ARB)
- Where
- South Korea
- Volunteers
- 632 people
- Sponsor
- Seoul National University Hospital
Severe Aortic Valve Stenosis, Aortic Valve Stenosis
Single Antiplatelet Treatment With Ticagrelor or Aspirin After Transcatheter Aortic Valve Implantation
The optimal pharmacological therapy after transcatheter aortic valve implantation (TAVI) to prevent valve thrombosis and reduce thromboembolic complications without significantly increasing the risk of bleeding is not yet fully…
- Conditions
- Severe Aortic Valve Stenosis, Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement (TAVR), Transcatheter Aortic Valve Implantation (TAVI)
- Trial name
- REAC-TAVI2 (NCT05283356)
- Testing
- Ticagrelor 60mg
- Where
- Spain
- Volunteers
- 1,206 people
- Sponsor
- Fundacin Biomedica Galicia Sur
Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement (TAVR)
CHATEAU Registry: Clinical Outcomes After Transcatheter Aortic Valve Replacement
This study is a multicenter, retrospective registry study using the CHATEAU Registry. The study will evaluate patients who underwent transcatheter aortic valve replacement between January 2021 and December 2025.
- Trial name
- CHATEAU (NCT07709858)
- Testing
- Transcatheter Aortic Valve Replacement
- Where
- South Korea
- Volunteers
- 4,000 people
- Sponsor
- Eunpyeong St. Mary's Hospital
Cardiac Surgery, Coronary Artery Bypass Graft
Micro- and Macro-Circulation in Cardiac Surgery Patients
The hypothesis under the study is that there could be a link between a dysfunction in peripheral microcirculation, sublingual microcirculation or cardiovascular control and the development of post cardiac surgery major…
- Conditions
- Cardiac Surgery, Coronary Artery Bypass Graft, Surgical Aortic Valve Replacement
- Trial name
- MiMaC (NCT05706545)
- Testing
- Acquisition of cardiovascular signals and microcirculation sidestream darkfield images
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- IRCCS Policlinico S. Donato
Valve Replacement Surgery
Comparison of Anti-Thrombotic Treatments Between Aspirin and Warfarin During Initial Six Months After Bioprosthetic Heart Valve Replacement
This trial is a multinational, multicenter, randomized, open-label, active-controlled clinical trial comparing the safety of aspirin versus vitamin K antagonists (warfarin) as oral antithrombotic therapy during the initial 6…
- Trial name
- CONCLAVE (NCT07431762)
- Testing
- Aspirin, Vitamin K antagonist(warfarin)
- Where
- 3 sites in Japan, South Korea
- Volunteers
- 1,058 people
- Sponsor
- Asan Medical Center
Transcatheter Aortic Valve Replacement
CT TAVR Abdomen Study
A standard polyenergetic CT (computed tomography) procedure utilizes 100 ml of iodinated contrast. A recent world-wide shortage of iodine based intravenous contrast has highlighted the need to search for alternative methods or…
- Trial name
- CT TAVR (NCT05758701)
- Testing
- Iodinated Contrast Agent (Omnipaque), Dual Energy CT
- Where
- United States
- Volunteers
- 164 people, healthy volunteers welcome
- Sponsor
- University of Maryland, Baltimore
Coronary Artery Bypass, Coronary Artery Bypass Graft
A Single Centre Study Comparing Continuous Interstitial Fluid Lactate Detection to Standard Measurements of Lactate in Patients Undergoing Elective Coronary Artery Bypass Graft Surgery and/or Valve Replacement.
The main goal of this study is to see if a wearable device can reliably track changes in lactate levels in the body. We\'ll compare the device\'s readings to standard blood tests to ensure accuracy.
- Conditions
- Coronary Artery Bypass, Coronary Artery Bypass Graft, Coronary Artery Bypass Graft Surgery (CABG), Valve Replacement
- Trial name
- CONTINUUM LINT (NCT06602336)
- Testing
- Continuous Lactate Monitoring Device
- Where
- United Kingdom
- Volunteers
- 61 people
- Sponsor
- Queen Mary University of London