Clinical trials: Aortic Stenosis
Aortic Valve Disease, Aortic Stenosis
Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement
Prospective, randomized, stratified non blinded multi-center, international, post market trial assessed in a non-inferiority study. The trial has a flexible sample size that will be determined adaptively.
- Trial name
- PERSIST-AVR (NCT02673697)
- Testing
- Perceval valve, other stented biological valve
- Where
- 47 sites in United States, Austria and 10 more
- Volunteers
- 914 people
- Sponsor
- Corcym S.r.l
Aortic Valve Disease
Safety and Feasibility of TRISKELE in Severe AS
This clinical study is a prospective、single arm and exploratory study, to explore the feasibility and safety of MitrAssist TRISKELE® transcatheter aortic valve system in the treatment of patients with severe aortic stenosis.
- Trial name
- NCT05391191
- Testing
- MitrAssist TRISKELE® transcatheter aortic valve system
- Where
- China
- Volunteers
- 7 people
- Sponsor
- Shanghai Zhongshan Hospital
Obstructive Hypertrophic Cardiomyopathy (oHCM)
Biological Collection for the Purpose of Exploring Genetic and Clinical-biological Factors Associated With Variability in Response to Mavacamten in the Treatment of Obstructive Hypertrophic Cardiomyopathy
The European Medicines Agency has required pre-treatment genotyping of CYP2C19 to determine the initial and maximum dosage, in order to avoid overexposure to mavacamten associated with a decrease in ventricular ejection fraction…
- Trial name
- MAVA PG (NCT07439952)
- Where
- 3 sites in France
- Volunteers
- 300 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Aortic Valve Stenosis
EMPagliflozin After Aortic Valve Replacement
The study is a randomized, placebo-controlled, and double-blinded trial in patients with aortic stenosis (AS) undergoing aortic valve replacement (AVR).
- Trial name
- EMPAVR (NCT06171802)
- Testing
- Empagliflozin
- Where
- Denmark
- Volunteers
- 206 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
HCM - Hypertrophic Cardiomyopathy, S-ICD System (implantable Defibrillator)
An Observational Study of Subcutaneous Implantable Cardioverter Defibrillator in Patients with Hypertrophic Cardiomyopathy At High Risk of Sudden Cardiac Death
1. To observe the failure rate of S-ICD screening in HCM patients at high risk of SCD. 2. To observe the incidence of IAS in HCM patients with S-ICD implantation and explore the related factors of IAS.
- Trial name
- NCT06604169
- Where
- China
- Volunteers
- 589 people
- Sponsor
- China National Center for Cardiovascular Diseases
Heart Failure, Cardiomyopathy, Hypertrophic
A Noninterventional, Single-Center Feasibility Study to Evaluate Measures of Heart Failure Risk
This is a non-invasive/observational study in healthy and mild HF subjects utilizing clinical and ambulatory measurements to improve detection, monitoring, and management of HF risks.
- Conditions
- Heart Failure, Cardiomyopathy, Hypertrophic, Left Ventricular Hypertrophy
- Trial name
- NCT05646056
- Testing
- Software
- Where
- United States
- Volunteers
- 82 people
- Sponsor
- Prolaio
Hypertrophic Cardiomyopathy
Morbidity and Mortality in Patients With Hypertrophic Cardiomyopathy: a CALIBER Study
The aim of this project is to study the association of a number of demographic and cardiovascular risk factors with death, health care utilisation and systemic embolisation by examining the clinical evolution of hypertrophic…
- Trial name
- HCM (NCT02424994)
- Testing
- No intervention
- Where
- United Kingdom
- Volunteers
- 12,464 people, healthy volunteers welcome
- Sponsor
- University College, London
Aortic Valve Stenosis
Study to Improve Outcomes in Aortic Stenosis
Multi-centre, multi-national, observational, prospective registry in four central full access centres in Germany (2), France (1) and the United Kingdom (1) and up to two satellites per hub (smaller hospitals / office based…
- Trial name
- NCT03112629
- Where
- 2 sites in France, Germany
- Volunteers
- 791 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
Mitral Regurgitation (MR), Moderate or Severe Aortic Stenosis (AS) (Mean Pressure Gradient ≥ 20 mm Hg or Aortic Valve Area ≤ 1.5 cm2)
Impact of Automatic Prompts in Echocardiographic Reports on Referral to Cardiology
Echo Prompts study is a multi-center randomized controlled study to evaluate the impact of automatic prompts added to the conclusion of the echocardiographic reports of patient diagnosed with significant VHD 1) suggesting…
- Trial name
- Echo Prompts (NCT06816888)
- Testing
- No Prompt, Prompt 1, Prompt 2
- Where
- Canada
- Volunteers
- 300 people
- Sponsor
- Ottawa Heart Institute Research Corporation
Aortic Valve Stenosis, Valvular Heart Disease
CoreValve Advance-II Study: Prospective International Post-market Study
The CoreValve ADVANCE-II Study is a best practices investigation of patients implanted with the Medtronic CoreValve bioprosthesis.
- Trial name
- Advance-II (NCT01624870)
- Where
- 9 sites in Belgium, Czechia and 4 more
- Volunteers
- 200 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Stenosis; Valve, Renal Failure
Transcatheter Implantation of Aortic Bioprosthesis Without the Use of Iodinated Contrast in Patients With Chronic Kidney Disease
Acute renal failure (ARF) after transcatheter aortic valve implantation (TAVI) is a frequent complication, with significant clinical consequences.
- Conditions
- Stenosis; Valve, Renal Failure, Renal Insufficiency
- Trial name
- NCT04581694
- Testing
- TAVI without contrast
- Where
- Brazil
- Volunteers
- 75 people
- Sponsor
- University of Sao Paulo General Hospital
Calcification of Aortic Valve, Aortic Valve Stenosis
Effects of Pioglitazone in Calcific Aortic Valve Disease
This is a prospective, randomized, comparative, clinical trial conducted by Wuhan Union Hospital that aims to evaluate the efficacy and safety of pioglitazone compared to placebo in patients with calcific aortic valve disease…
- Trial name
- NCT05875675
- Testing
- Drug: Pioglitazone Oral Tablet
- Volunteers
- 100 people
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Hypertrophic Cardiomyopathy
Diagnosis of HCM With AI-ECG
The study aims to establish a diagnostic model of hypertrophic cardiomyopathy with artificial intelligence-enhanced electrocardiogram.
- Trial name
- NCT06287892
- Where
- China
- Volunteers
- 10,000 people, healthy volunteers welcome
- Sponsor
- Shanghai Zhongshan Hospital
Aortic Stenosis
Assessment of Myocardial Tissue Damage in Aortic Stenosis
Aortic stenosis (AS) is the most common valve disease in the United States and most common indication for valve replacement surgery. Anatomical and hemodynamic severity of AS is insufficient for elucidating patients' prognosis.
- Trial name
- NCT02101619
- Where
- United States
- Volunteers
- 59 people
- Sponsor
- Mayo Clinic
Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: A Prospective Registry With Central Echocardiography Analysis.
The issue of valve durability has become one of the most important aspects in the TAVR field in recent years since transcatheter aortic valve replacement has been progressively applied to younger patients with a low co-morbidity…
- Trial name
- NCT06420830
- Testing
- SAPIEN 3 Ultra RESILIA Valve
- Where
- Canada
- Volunteers
- 150 people
- Sponsor
- Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Aortic Coarctation, Pulmonary Artery Stenosis
First-in-human Clinical Trial to Assess Safety and Efficacy of the CardiaZn Bioresorbable Stent in Children With Pulmonary Artery Stenosis and Aortic Coarctation
This study evaluates the safety and effectiveness of the CardiaZn stent, a novel bioresorbable stent designed specifically for infants and children with congenital cardiovascular conditions.
- Trial name
- Pediasorb (NCT07628101)
- Testing
- CardiaZn Bioresorbable Stent
- Volunteers
- 45 people
- Sponsor
- PediaStent LLC
Aortic Valve Stenosis
HLT Meridian Valve CE Mark Trial
To evaluate the safety and performance of the HLT System in patients with symptomatic heart disease due to severe aortic stenosis who are judged by the Heart Team to be at Intermediate or High Risk for aortic valve replacement…
- Trial name
- RADIANT CE (NCT03805711)
- Testing
- HLT® Transcatheter System
- Where
- Canada
- Volunteers
- 1 people
- Sponsor
- HLT Inc.
Aortic Stenosis
An Investigational Drug on Clinical Outcomes in Patients With Aortic Stenosis (Narrowing of the Major Blood Vessel of the Heart)(MK-0653A-043 AM4)(COMPLETED)
The purpose of this study is to evaluate whether treatment with an investigational drug as compared to placebo will reduce the risk of major cardiovascular events in patients with aortic stenosis.
- Trial name
- NCT00092677
- Testing
- ezetimibe (+) simvastatin
- Volunteers
- 1,873 people
- Sponsor
- Organon and Co
Primary Hypertension, Secondary Hypertension
HaemoDYNAMICs in Primary and Secondary Hypertension
The primary aim of the present study was to examine the haemodynamic changes in primary hypertension and secondary hypertension (renal diseases, endocrine diseases, obesity-associated hypertension) with a non-invasive…
- Conditions
- Primary Hypertension, Secondary Hypertension, Aortic Stenosis, Renal Insufficiency
- Trial name
- DYNAMIC (NCT01742702)
- Testing
- Nitroglycerin 0.25 mg (single dose, no longer given since January 2017), Salbutamol 400 µg (single dose, no longer given since January 2017), L-arginine (10 min infusion, no longer given since January 2017)
- Where
- 2 sites in Finland
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Tampere University
Aortic Stenosis, Severe, Aortic Stenosis
Same-Day Versus Standard Hospital Discharge After TAVI (HOME-TAVI)
Transcatheter aortic valve implantation (TAVI) has become the standard treatment for patients with severe aortic stenosis across a broad range of surgical risk.
- Trial name
- HOME-TAVI (NCT07738575)
- Testing
- Same-Day Discharge Strategy, Standard-of-Care Discharge Strategy
- Where
- 3 sites in Canada, Spain
- Volunteers
- 764 people
- Sponsor
- Hospital Clinic of Barcelona
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