Clinical trials: Aortic Valve Disease
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.
Coronary Artery Disease, Valvular Heart Disease
Prehabilitation for Patients Undergoing Elective Cardiac Surgery
The objective of this clinical trial is to develop a novel rehabilitation model that, through the PRECICA program, will help to reduce perioperative and postoperative complications in the care process prior to planned cardiac…
- Conditions
- Coronary Artery Disease, Valvular Heart Disease, Chronic Thromboembolic Pulmonary Hypertension, Aortic Diseases
- Trial name
- PRECICA (NCT07704086)
- Testing
- Physical exercise, Educational program and respiration physiotherapy
- Where
- 2 sites in Spain
- Volunteers
- 86 people
- Sponsor
- Hospital Universitario 12 de Octubre
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
Bicuspid Aortic Valve
BIVOLUTX: Bicuspid Aortic Stenosis With Evolut Platform International Experience.
Prospective non interventional, observational registry of 150 patients undergoing TAVI with Evolut platform for bicuspid aortic stenosis.
- Trial name
- BIVOLUTX (NCT03495050)
- Testing
- Transcatheter Aortic Valve Implantation
- Where
- France
- Volunteers
- 150 people
- Sponsor
- Clinique Pasteur
Aortic Stenosis, Coronary Artery Disease
Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial
The primary objective of this study is to compare, in patients with severe aortic stenosis and concomitant coronary artery disease accepted for transcatheter aortic valve implantation (TAVI) and percutaneous coronary intervention…
- Conditions
- Aortic Stenosis, Coronary Artery Disease, TAVI, PCI
- Trial name
- TAVI-PCI (NCT04310046)
- Testing
- PCI before TAVI, PCI after TAVI
- Where
- 48 sites in Austria, France and 4 more
- Volunteers
- 986 people
- Sponsor
- University of Zurich
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
Valvular Heart Disease
Evaluation and Validation of Management Strategy for Conductive Disorders After TAVR (EVATAVI)
Considering decrease of major complications and improvement of procedural results, conductive disorders currently remain the main issue after TAVR (Transcatheter aortic valve replacement).
- Trial name
- EVATAVI (NCT05417464)
- Testing
- Use of flowchart
- Where
- France
- Volunteers
- 250 people
- Sponsor
- University Hospital, Montpellier
Calcific Aortic Stenosis, Calcific Aortic Stenosis - Bicuspid Valve
Identification of Genetic Causes of Calcific Aortic Valve Disease
This study aims to identify the molecular genetic causes of the variability in development of calcific aortic valve disease in bicuspid and tricuspid aortic valves and their associated aortic dilation.
- Conditions
- Calcific Aortic Stenosis, Calcific Aortic Stenosis - Bicuspid Valve, Aortic Valve Disease, Aortic Valve Calcification
- Trial name
- NCT04149600
- Testing
- Patients scheduled to undergo aortic valve replacement or aortic surgery at BIDMC will be approached for participation in this study.
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Beth Israel Deaconess Medical Center
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
Aortic Valve Disease
Transcranial Doppler (TCD) Assessment During Early Anti-thrombotic Therapy After Bioprosthetic Aortic Valve Replacement
The purpose of this study is to determine if there is any difference in the counts of cerebral emboli and platelet function between two prophylactic treatments of thrombosis currently used at University of Ottawa Heart Institute…
- Trial name
- Tissue-Valve (NCT00465218)
- Testing
- Prophylaxis of Thrombosis after aortic valve replacement
- Where
- Canada
- Volunteers
- 70 people
- Sponsor
- Ottawa Heart Institute Research Corporation