Clinical trials: Aortic Valve Disease, open to volunteers
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
Familial Hypercholesterolemia - Homozygous
Study to Evaluate Safety, Tolerability and Efficacy of Inclisiran in Children With Homozygous Familial Hypercholesterolemia
This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in children (aged 2 to <12 years) with homozygous familial hypercholesterolemia (HoFH) and elevated low density lipoprotein…
- Trial name
- ORION-19 (NCT06597006)
- Testing
- Inclisiran
- Where
- 19 sites in United States, Austria and 9 more
- Volunteers
- 9 people
- Sponsor
- Novartis Pharmaceuticals
Complex Congenital Heart Defect, Dysfunctional RVOT Conduit
COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
This study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems in subjects with a dysfunctional right ventricular outflow tract (RVOT)…
- Conditions
- Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration
- Trial name
- NCT02744677
- Testing
- SAPIEN 3/SAPIEN 3 Ultra RESILIA THV, SAPIEN 3 THV, SAPIEN 3 Ultra RESILIA THV
- Where
- 27 sites in United States
- Volunteers
- 108 people
- Sponsor
- Edwards Lifesciences
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
Aortic Stenosis
Multicenter Study for the Validation of Willem AI: Aortic StenoSis Early Diagnosis With AI-electrocardiogram Study
AoS-SEDAI study is an observational, multicenter, retrospective and prospective clinical study. This study aims to assess Willem Artificial Intelligence (AI) ability to distinguish between aortic stenosis (AS) and non-AS patients…
- Trial name
- AoS-SEDAI (NCT07479992)
- Testing
- Willem AI ECG assessment
- Where
- 2 sites in Germany
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Idoven 1903 S.L.
Aortic Stenosis
Post-Market Clinical Follow Up Study With Navitor Valve
Evaluation of the safety and performance of the Navitor TAVI System in a Global Study
- Trial name
- VISTA Nova (NCT06008080)
- Testing
- Navitor Transcatheter Aortic Valve, FlexNav Delivery System, Navitor Loading System
- Where
- 50 sites in Australia, France and 9 more
- Volunteers
- 1,000 people
- Sponsor
- Abbott Medical Devices
Aortic Stenosis Disease, Valvular Heart Disease
Optimized Expansion of the Implanted Transcatheter Aortic Valve
Optimized Expansion of the implanted transcatheter aortic valve to reduce hypoattenuating leaflet thickening in non-atrial fibrillation patients undergoing transcatheter aortic valve implantation (TAVI): an international…
- Trial name
- OptEx-TAVI (NCT07042529)
- Testing
- OptEx-TAVI, SoC-TAVI
- Where
- 17 sites in Belgium, Denmark and 4 more
- Volunteers
- 1,010 people
- Sponsor
- Ole De Backer
AORTIC VALVE DISEASES, Thromboembolism
Long-term Anticoagulation With Oral Factor Xa Inhibitor Versus Vitamin K Antagonist After Mechanical Aortic Valve Replacement
This study evaluates the long-term anticoagulation with oral factor Xa inhibitor versus vitamin K antagonist in patients receiving a mechanical aortic valve replacement.
- Trial name
- RENOVATE (NCT04258488)
- Testing
- Rivaroxaban Oral Tablet, Vitamin K antagonist(warfarin)
- Where
- 16 sites in South Korea
- Volunteers
- 1,300 people
- Sponsor
- Joon Bum Kim
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
Transcatheter Aortic Valve Replacement
Comparison of Single vs. Dual Perclose Devices for Large-Bore Access Closure in TAVR
This study will compare the use of one Perclose device to the usual approach of two devices for pre-closure during Transcatheter Aortic Valve Replacement (TAVR).
- Trial name
- NCT06871774
- Testing
- Single Perclose Pro vascular closure device, Dual Perclose vascular closure device
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Wake Forest University Health Sciences
Valve Heart Disease, Coronary Artery Disease
Construction of a Prospective Cohort Database for the Perioperative Period of Cardiac Surgery
Cardiovascular disease (CVD) is the leading cause of global morbidity and mortality, with its prevalence increasing significantly from 1990 to 2019.
- Conditions
- Valve Heart Disease, Coronary Artery Disease, Coronary Heart Disease, Aortic Diseases
- Trial name
- NCT07662317
- Testing
- Cardiac surgey
- Where
- China
- Volunteers
- 10,000 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Aortic Aneurysm and Dissection, Coronary Artery Disease (CAD)
Effects of Myofascial Release on Cardiac Patients After Median Sternotomy
After deciding to join this study and signing the informed consent form, participants will undergo the following interventions: All participants will receive a preoperative assessment (Tp) before surgery.
- Conditions
- Aortic Aneurysm and Dissection, Coronary Artery Disease (CAD), Valve Heart Disease
- Trial name
- NCT07649330
- Testing
- myofascial release+Routine Physical Therapy, Routine Physical therapy
- Where
- Taiwan
- Volunteers
- 50 people
- Sponsor
- Siou-Pin Huang
Aortic Valve, Bicuspid
Follow-up of a Cohort of Patients With Aortic Valve Bicuspidia
The aortic valve bicuspidia (BVA) is a congenital condition corresponding to the presence of 2 sigmoids instead of 3. This is the most common cardiac congenital anomaly affecting 0.5 to 2% of the population The general rule.
- Trial name
- NCT03139786
- Testing
- Study the natural history of bicuspid
- Where
- France
- Volunteers
- 232 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Aortic Stenosis, Chronic Coronary Syndrome
Derivation and Validation of the Aortic Valve Echocardiographic Calcium Score to Confirm Severe Aortic Stenosis: the Echo-AVCS Study
The Echo-AVCS Study is an investigator-initiated, prospective, multicenter observational study designed to derive and validate an artificial intelligence (AI)-based echocardiographic aortic valve calcium score (Echo-AVCS) for…
- Conditions
- Aortic Stenosis, Chronic Coronary Syndrome, Calcific Aortic Valve Disease, Calcific Aortic Stenosis
- Trial name
- Echo-AVCS (NCT07620925)
- Testing
- Echocardiography and Cardiac CT
- Where
- 5 sites in Italy
- Volunteers
- 250 people
- Sponsor
- Azienda Ospedaliera "Sant'Andrea"
Aortic Valve Stenosis, Chronic Kidney Diseases
Impact of Trans-catheter Aortic Valve Implantation on Renal Function
Both contrast-induced acute kidney injury (AKI) and pre-existing chronic kidney disease are associated with an increased mortality risk in patients requiring aortic valve replacement.
- Conditions
- Aortic Valve Stenosis, Chronic Kidney Diseases, Renal Failure Acute Chronic
- Trial name
- TAVIKOD (NCT07626710)
- Testing
- Trans-catheter aortic valve implantation (TAVI)
- Where
- Italy
- Volunteers
- 1,000 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Aortic Stenosis Disease
Aortic Stenosis - Prognosis, Risk and Outcomes
The investigators will prospectively enroll 300 patients undergoing TAVI at Sahlgrenska University Hospital, which is the second largest TAVI hospital in Sweden.
- Trial name
- MASTER (NCT06863883)
- Where
- 2 sites in Sweden
- Volunteers
- 300 people
- Sponsor
- Vastra Gotaland Region
AORTIC VALVE DISEASES, Bicuspid Aortic Valve (BAV)
Sapien 3 Transcatheter Aortic Valve Replacement in Young Aortic Valve Stenosis Patients From China
Safety, effectiveness and durability of Sapien 3 transcatheter aortic valve replacement in young aortic valve stenosis patients from China：A multi-center, retrospective and prospective, single arm, observational study
- Trial name
- NCT06830499
- Testing
- Transcatheter Aortic Valve Replacement (TAVR)
- Where
- 4 sites in China
- Volunteers
- 450 people
- Sponsor
- Xijing Hospital
Severe Aortic Stenosis
Navitor Japan Study
The Navitor Japan Study is designed to evaluate the safety and performance of the Navitor™ valve used in combination with the FlexNav™ delivery system in a contemporary, real-world setting.
- Trial name
- NCT07193888
- Testing
- Navitor Transcatheter Aortic Valve Implantation
- Where
- 3 sites in Japan
- Volunteers
- 100 people
- Sponsor
- Abbott Medical Devices
Type A Aortic Dissection, Ascending Aortic Dissection
Outcomes of Aortic Dissection Repair
Type A aortic dissection (TAAD) is a potentially life-threatening pathology associated with significant risk of mortality and morbidity.
- Conditions
- Type A Aortic Dissection, Ascending Aortic Dissection, Aortic Diseases, Aortic Arch
- Trial name
- STAAD (NCT05927090)
- Testing
- Conservative Root- Sparing Aortic Valve Resuspension with or without Hemiarch Repair, Extensive Ascending Aorta Replacement (AAR) with Aortic Root Replacement (ARR), Extensive Ascending Aorta Replacement (AAR) with Total Arch Replacement (TARP)
- Where
- France
- Volunteers
- 1,200 people
- Sponsor
- Centre Cardiologique du Nord
Familial Hypercholesterolemia - Heterozygous
Study to Evaluate Efficacy and Safety of Inclisiran in Children With Heterozygous Familial Hypercholesterolemia
This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in children (aged 6 to <12 years) with heterozygous familial hypercholesterolemia (HeFH) and elevated low density lipoprotein…
- Trial name
- ORION-20 (NCT06597019)
- Testing
- Inclisiran
- Where
- 66 sites in United States, Argentina and 21 more
- Volunteers
- 60 people
- Sponsor
- Novartis Pharmaceuticals