Clinical trials: Aortic Stenosis
Aortic Valve Stenosis
Evaluation of BAV in Different Hemodynamic Entities of Severe AS
The purpose of this retrospective, observational study is to compare the profit of BAV and TAVI in different subtypes of serve aortic stenosis.
- Trial name
- BAV (NCT04053192)
- Testing
- BAV, BAV + TAVR, SAVR
- Where
- Germany
- Volunteers
- 166 people
- Sponsor
- Heinrich-Heine University, Duesseldorf
Coronary Artery Disease, Aortic Stenosis, Severe
NIRS-IVUS to Improve Assessment of Coronary Artery Disease Severity in Patients Referred for Transcatheter Aortic Valve Implantation
The aim of the IMPACTavi prospective cohort study is to test feasibility and safety of clinically indicated intravascular coronary imaging with NIRS-IVUS in addition to routine coronary angiography in patients scheduled for TAVI…
- Trial name
- IMPACTavi (NCT04976062)
- Testing
- Combined near-infrared spectroscopy and intravascular ultrasound imaging (NIRS-IVUS)
- Where
- 2 sites in Germany, Switzerland
- Volunteers
- 150 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Aortic Stenosis
Medtronic CoreValve Evolut R U.S. Clinical Study
The study objectives are to assess the safety and efficacy of the CoreValve Evolut R transcatheter aortic valve replacement (TAVR) system in patients with severe symptomatic aortic stenosis are considered at high or extreme risk…
- Trial name
- NCT02207569
- Testing
- CoreValve Evolut R TAVR system
- Where
- 23 sites in United States
- Volunteers
- 241 people
- Sponsor
- Medtronic Cardiovascular
Aortic Valve Stenosis, TAVI
Exercise Training After Transcatheter Aortic Valve Implantation
In this prospective, controlled trial, patient after TAVI will be randomized to either exercise training or usual care group.
- Conditions
- Aortic Valve Stenosis, TAVI, Transcatheter Aortic Valve Implantation, Rehabilitation
- Trial name
- FitTAVI (NCT03966417)
- Testing
- Exercise training
- Where
- Slovenia
- Volunteers
- 30 people
- Sponsor
- University Medical Centre Ljubljana
Amyloidosis, Aortic Valve Stenosis
Early Detection of Cardiac Amyloidosis
Due to a lack of therapeutic options, the diagnosis of cardiac (wt)-ATTR amyloidosis was for a long time overshadowed by other diseases and therefore was or still is often diagnosed with considerable delay.
- Trial name
- NCT05010980
- Testing
- CMR, scintigraphy
- Where
- Germany
- Volunteers
- 400 people
- Sponsor
- Heinrich-Heine University, Duesseldorf
Iron Deficiency Anemia Due to Blood Loss, Aortic Stenosis
IV Sodium Ferric Gluconate Complex in Patients Undergoing TAVI
Iron deficiency is common among patients undergoing TAVI. It is estimated at 54-79%. Previous non-randomized small trial have shown symptomatic benefit in treating iron deficiency in this group of patients.
- Trial name
- NCT04797832
- Testing
- IV Sodium Ferric Gluconate Complex
- Where
- Israel
- Volunteers
- 200 people
- Sponsor
- Rambam Health Care Campus
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
Severe Aortic Stenosis
Safety and Efficacy Continued Access Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in Very High Risk Subjects and 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 very high risk and high risk for aortic…
- Trial name
- NCT01531374
- Testing
- Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 45 sites in United States
- Volunteers
- 2,777 people
- Sponsor
- Medtronic Cardiovascular
Aortic Stenosis, Calcific
Prognostic Value of Myocardial Fibrosis in Severe Aortic Valve Stenosis
Degenerative aortic valve stenosis (AS) is the most common valve heart disease in the developed Western countries. The hemodynamic progression of AS occurs over time and leads to LV hypertrophy (LVH) as a compensation mechanism…
- Trial name
- FIB-AS (NCT03585933)
- Testing
- Cardiac magnetic resonance imaging
- Where
- 2 sites in Denmark, Lithuania
- Volunteers
- 110 people
- Sponsor
- Vilnius University
Aortic Valve Stenosis
Early neo2 Registry of the Acurate neo2 TAVI Prosthesis
The Early neo2 registry will study up to 500 patients treated with the updated Boston Acurate neo2 TAVI prosthesis at various European hospitals.
- Trial name
- NCT04810195
- Testing
- Boston Scientific Acurate neo2 TAVR device
- Where
- 4 sites in Denmark, Germany and 1 more
- Volunteers
- 554 people
- Sponsor
- Andreas Rück
Calcific Aortic Valve Disease, Aortic Valve Stenosis
Serum and Cellular Biomarkers for Aortic Valve Stenosis
AthenaValve aims to develop and initial validate a novel serum diagnostic kit, for the assessment of severity and prognosis of progression of aortic valve stenosis (AS, a devastating disease without early diagnosis and medical…
- Conditions
- Calcific Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve, Calcification of
- Trial name
- AthenaValve (NCT04312139)
- Testing
- Echocardiography, Computerized Tomography Aortic Valve Calcium Score, Untargeted LC/MS and LC-MS/MS
- Where
- 2 sites in Greece
- Volunteers
- 280 people
- Sponsor
- National and Kapodistrian University of Athens
Aortic Valve Stenosis, Multidetector Computed Tomography
The Aortic Valve DECalcification (AVADEC) Trial
Aortic stenosis is a common heart valve disease and due to the growing elderly population the prevalence is increasing. The disease is progressive with increasing calcification of the valve cusps.
- Conditions
- Aortic Valve Stenosis, Multidetector Computed Tomography, Vitamin K 2, Randomised Clinical Trial
- Trial name
- AVADEC (NCT03243890)
- Testing
- Menaquinone-7 720 µg/day including the recommended daily dose of vitamin D (25 µg/day).
- Where
- Denmark
- Volunteers
- 389 people
- Sponsor
- Axel Diederichsen
Severe Aortic Stenosis
Safety and Performance Study of the Optimum Transcatheter Aortic Valve
The TAVI (Thubrikar Aortic Valve, Inc.) -1 Study: Safety and Performance Study of the Optimum Transcatheter Aortic Valve- First-in-human study to assess feasibility and safety of the Optimum Aortic Valve Implant
- Trial name
- NCT04076150
- Testing
- Transcatheter Aortic Valve (TAV) Implantation With The Optimum TAV System
- Where
- Poland
- Volunteers
- 5 people
- Sponsor
- Thubrikar Aortic Valve, Inc.
Aortic Stenosis, Aortic Regurgitation
Study to Evaluate the Effect on Improvement of LVH by the Control of BP in Hypertension Patients With AV Disease
To compare changes in Left Ventricular Mass (LVM) depending on each blood pressure regulation between the intensive care group and the usual care group for patients with hypertension accompanied by aortic valve disease and…
- Conditions
- Aortic Stenosis, Aortic Regurgitation, Hypertension, LVM
- Trial name
- NCT03666351
- Testing
- Amlodipine 5mg, Losartan, Losartan and Amlodipine
- Where
- South Korea
- Volunteers
- 128 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Aortic Valve Stenosis, Transcatheter Aortic Valve Implantation
Safety and Efficacy of Emergent TAVI in Patients With Severe AS
This is a single-centre, prospective, observational cohort study focusing on of patients suffering severe aortic valve stenosis (AS) undergoing emergent transcatheter aortic valve implantation (TAVI).
- Conditions
- Aortic Valve Stenosis, Transcatheter Aortic Valve Implantation, Emergencies
- Trial name
- NCT05528211
- Volunteers
- 10 people
- Sponsor
- Qilu Hospital of Shandong University
Aortic Valve Stenosis
STS/ACC Transcatheter Valve Therapy Registry (TVT Registry)
The TVT Registry™ is a benchmarking tool developed to track patient safety and real-world outcomes related to the transcatheter aortic valve replacement (TAVR) procedure.
- Trial name
- TVTR (NCT01737528)
- Testing
- Transcatheter Aortic Valve Replacement
- Where
- United States
- Volunteers
- 16,000 people
- Sponsor
- The Society of Thoracic Surgeons
Aortic Valve Stenosis
CPX in Paradoxical Low Flow Aortic Stenosis
Severe aortic stenosis is a condition with poor life expectancy once it becomes symptomatic. There are no prospective studies illustrating the utility of cardiopulmonary stress (CPX) testing in diagnosing and prognosticating…
- Trial name
- NCT05481814
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Henry Ford Health System
Aortic Valve Stenosis, Cognitive Impairment
Cardiac Output, Cerebral Perfusion and Cognition in Patients Undergoing TAVI
Rationale: Cardiovascular disease and cognitive diseases are closely related. Cognitive impairment is common (21-39%) among patients with severe aortic valve stenosis.
- Conditions
- Aortic Valve Stenosis, Cognitive Impairment, Cognitive Change
- Trial name
- CAPITA (NCT05481008)
- Testing
- transcatheter aortic valve implantation
- Where
- Netherlands
- Volunteers
- 142 people
- Sponsor
- Ronak Delewi
Aortic Valve Stenosis
Rotterdam EDOXaban Leaflet Evaluation in Patients After Transcatheter Aortic Valve Implantation
A single-center, investigator-initiated, single arm interventional study in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) in the Erasmus Medical Center in Rotterdam (NL).
- Trial name
- REDOX-TAVI (NCT04171726)
- Testing
- Edoxaban
- Where
- Netherlands
- Volunteers
- 100 people
- Sponsor
- Erasmus Medical Center
Aortic Valve Stenosis, Bicuspid Cardiac Valve
Addition of Computer Simulations to Minimize Adverse Events After Transcatheter Aortic Valve Implantation
The objective is to assess the influence of FEops HEARTguide on overall device success in TAVI patients with challenging anatomies (Cohort A) or in transcatheter heart valve (THV) platform selection (Cohort B).
- Trial name
- PRECISE_TAVI (NCT04473443)
- Testing
- FEops HEARTguideTM
- Where
- Netherlands
- Volunteers
- 200 people
- Sponsor
- Erasmus Medical Center