Clinical trials: Aortic Valve Stenosis
Aortic Stenosis
PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis
To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement.
- Trial name
- P3 (NCT02675114)
- Testing
- SAVR, SAPIEN 3 THV
- Where
- 77 sites in United States, Australia and 3 more
- Volunteers
- 1,000 people
- Sponsor
- Edwards Lifesciences
Hypertrophic Cardiomyopathy
A Study to Assess Health-Related Quality of Life in Patients With Hypertrophic Cardiomyopathy in Japan
This cross-sectional, non-interventional study will assess health-related quality of life in in patients with hypertrophic cardiomyopathy in Japan. The study consists of two phases.
- Trial name
- NCT06181617
- Testing
- Quality of life assessment
- Where
- Japan
- Volunteers
- 149 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Mitral Valve Insufficiency, Aortic Stenosis Senile
Clinical and Geriatric Assessment in Elderly Patients Before and After TAVI or MitraClip Positioning
Since October of 2014, the Policlinico Umberto I Hospital has an "Heart Team", a group of selected specialists with the task of assessing and identifying eligible patients for valvular aortic transcatheter implantation (TAVI) or…
- Trial name
- NCT03145376
- Testing
- geriatric assessment
- Where
- 2 sites in Italy
- Volunteers
- 100 people
- Sponsor
- University of Roma La Sapienza
Aortic Stenosis
Transcatheter Heart Valve (THV) Sizing and Leakage After Transcatheter Aortic Valve Implantation (TAVI) Before and After Establishing Routine Preprocedure Multi Slice Computerized Tomography (MSCT) Aortic Assessment. A Retrospective Registry Study
The objective of this study is to evaluate the effect of annular sizing strategy (MDCT versus TEE) in transcatheter aortic valve implantation on the prevalence and severity of paravalvular regurgitation.
- Trial name
- NCT02005640
- Where
- Denmark
- Volunteers
- 150 people
- Sponsor
- Aarhus University Hospital Skejby
Aortic Stenosis
Construction and Application Plan of Home Cardiac Rehabilitation for Patients Undergoing TAVR
Cardiac rehabilitation is a long-term process, but patients have poor compliance with cardiac rehabilitation. The theory of behavior change rotation aims to comprehensively intervene from three aspects: ability, opportunity, and…
- Trial name
- NCT06418555
- Testing
- A home rehabilitation program centered on exercise
- Where
- China
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Severe Aortic Valve Disease
Five-year Outcomes of Rapid-deployment Aortic Valve Replacement With the Edwards Intuity TM Valve
Objectives: This report presents 5-year outcomes of the rapid-deployment Edwards Intuity TM valve in a single-center prospective study.
- Trial name
- NCT04696926
- Testing
- Edwards Intuity TM Valve implantation
- Where
- France
- Volunteers
- 170 people
- Sponsor
- Assistance Publique Hopitaux De Marseille
Heart Disease
4 Cities for Assessing CAlcification PRognostic Impact After TAVI
Transcatheter Aortic Valve Implantation (TAVI) indications are progressing rapidly as an alternative to conventional surgery for aortic stenosis cure.
- Trial name
- C4CAPRI (NCT02935491)
- Testing
- Transcatheter Aortic Valve Implantation (TAVI)
- Where
- France
- Volunteers
- 1,600 people
- Sponsor
- Hospices Civils de Lyon
Aortic Valve Stenosis
Controlled Arterial Protection to Ultimately Remove Embolic Material
The objective of this study is to demonstrate device feasibility, safety and investigate performance of the EmStop Embolic Protection System when used as indicated in 15 subjects at 2 investigational sites in the U.S.
- Trial name
- CAPTURE-1 (NCT06103591)
- Testing
- The EmStop Embolic Protection System (EmStop System)
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- EmStop Inc
Aortic Valve Stenosis
Transfemoral Replacement of Aortic Valve With HLT MeriDIAN Valve Feasibility Trial CANADA
To evaluate the safety and performance of the HLT System in patients with severe aortic stenosis who present at high risk for aortic valve replacement surgery.
- Trial name
- RADIANT CANADA (NCT02838680)
- Testing
- HLT Transcatheter Aortic Valve System
- Where
- 2 sites in Canada
- Volunteers
- 15 people
- Sponsor
- HLT Inc.
Aortic Valve Stenosis
Improving Echo Measurements in the Diagnosis of Aortic Stenosis
Aortic stenosis is a common valvular heart disease, affecting mainly people over age 60. It is characterized by years to decades of slow progression followed by rapid clinical deterioration and a high death rate once symptoms…
- Trial name
- NCT02146755
- Where
- 2 sites in United States
- Volunteers
- 396 people
- Sponsor
- Baylor Research Institute
Aortic Stenosis Disease
Clinical and CPET Parameters That Predict Improvement in Functional Capacity After TAVI
Determining Clinical and Cardiopulmonary exercise testing Parameters that may predict Improvement in Capacity After Transcatheter Aortic Valve Implantation
- Trial name
- NCT06833762
- Where
- Spain
- Volunteers
- 161 people
- Sponsor
- Hospital Clinic of Barcelona
Renal Infarction
Trans-aortic Valve Replacement and Renal Infarction
Kidney Magnetic Resonance assessment before and after undergoing transcatheter aortic valve replacement
- Trial name
- NCT03474250
- Testing
- Magnetic Resonance test for kidney
- Where
- Israel
- Volunteers
- 20 people
- Sponsor
- Sheba Medical Center
Acute Pain
Human Experimental Models of Pain (HEMP)
This pilot study will test an innovative way to establish how pain medicines provide analgesia in healthy adults. The study uses a group of short, controlled pain tests to look at different types of pain responses in the body.
- Trial name
- NCT07549490
- Testing
- Naproxen, Pregabalin
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- National Center for Complementary and Integrative Health (NCCIH)
Cardiomyopathy, Hypertrophic, Physical Exercise
Effect of an Aerobic Exercise Session on Cardiovascular and Autonomic Parameters of Adults With Hypertrophic Cardiomyopathy
Hypertrophic cardiomyopathy is a genetic heart disease with symptoms that may include dyspnea and fatigue predominantly on exertion, with or without chest pain, palpitations, syncope/presyncope and sudden cardiac death, mostly in…
- Conditions
- Cardiomyopathy, Hypertrophic, Physical Exercise, Autonomic Nervous System, Endothelium
- Trial name
- NCT07127640
- Testing
- Exercise
- Where
- Brazil
- Volunteers
- 10 people
- Sponsor
- Instituto de Cardiologia do Rio Grande do Sul
Cardiovascular Diseases, Heart Diseases
Reproduction and Survival After Cardiac Defect Repair
To create a registry of all Oregon children undergoing surgical repair of congenital heart disease since 1958 in order to determine mortality, morbidity, and disability after surgery and to assess the safety of pregnancy in women…
- Conditions
- Cardiovascular Diseases, Heart Diseases, Defect, Congenital Heart, Aortic Valve Stenosis
- Trial name
- NCT00005190
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Aortic Valve Stenosis
PREVAIL-20J - Transfemoral Placement of 20mm Aortic Balloon Expandable Transcatheter Valve Trial
A single arm, prospective multicenter non-randomized pivotal clinical trial evaluating the 20mm Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX), NovaFlex™ transfemoral delivery system, and crimper accessories.
- Trial name
- PREVAIL-20J (NCT01419015)
- Testing
- SAPIEN XT NovaFlex delivery system
- Where
- 4 sites in Japan
- Volunteers
- 17 people
- Sponsor
- Edwards Lifesciences
Severe Symptomatic Aortic Stenosis (Defined as New York Heart Association (NYHA) Class ≥ II)
PERFECT - Portuguese Evolut Registry Studying the Outcomes of Medtronic Evolut™ FX+ TAVI System by Evaluating an Optimal Care Pathway for TAVI
The goal of this registry is to learn how the Medtronic Evolut™ FX+ transcatheter aortic valve implantation (TAVI) System performs in adults with severe, symptomatic aortic stenosis who need valve replacement.
- Trial name
- PERFECT (NCT07343674)
- Where
- 12 sites in Portugal
- Volunteers
- 500 people
- Sponsor
- Portuguese Association of Interventional Cardiology
Aortic Valve Stenosis
Biological Variation of Cardiac Biomarkers in Aortic Valve Stenosis
Calcified aortic valve stenosis (CAVS) is a progressive disease and nowadays, the cornerstone in diagnostics and follow-up is echocardiography.
- Trial name
- NCT02510482
- Testing
- No intervention
- Where
- Netherlands
- Volunteers
- 25 people
- Sponsor
- Maastricht University Medical Center
Hypertrophic Cardiomyopathy
Will Elevated Left Ventricle Filling Pressures Decrease by a Group Exercise Program in Patients With Hypertrophic CardioMyopathy?
Aims and objectives: The primary objective of this study is to assess whether a structured exercise program improves cardiac relaxing properties in patients with hypertrophic cardiomyopathy (HCM).
- Trial name
- WEDGE-HCM (NCT03537183)
- Testing
- Exercise training
- Where
- Denmark
- Volunteers
- 61 people
- Sponsor
- Bispebjerg 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
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