Clinical trials: AORTIC VALVE DISEASES
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 Stenosis Disease
Impact of Enhanced Information on Subjective Information Level and PROMs in Patients with Aortic Stenosis
The aim of this trial is to evaluate if an enhanced information by using a mobile App can increase subjective information level in patients with severe aortic stenosis and may therefore improve patient-reported outcomes.
- Trial name
- TAVI-SDM-APP (NCT06706635)
- Testing
- Application of App
- Where
- Germany
- Volunteers
- 250 people
- Sponsor
- Heart and Diabetes Center North-Rhine Westfalia
Aortic Valve Stenosis, Valve Heart Stenosis
Prospective European Multicenter Study on Aortic Valve Replacement: (E-AVR Registry)
Traditional and transcatheter surgical treatments of severe aortic valve stenosis (SAVS) are increasing in parallel with the improved life-expectancy.
- Trial name
- E-AVR (NCT03143361)
- Testing
- Aortic valve replacement
- Where
- Italy
- Volunteers
- 8,000 people
- Sponsor
- University of Parma
Hypertrophic Cardiomyopathy
Insertable Cardiac Monitors in Hypertrophic Cardiomyopathy
Hypertrophic cardiomyopathy (HCM) is associated with sudden cardiac death and an increased risk of atrial fibrillation and subsequent embolic event.
- Trial name
- ElucidateHcm (NCT03259113)
- Testing
- Insertable cardiac monitor
- Where
- Sweden
- Volunteers
- 30 people
- Sponsor
- Region Gävleborg
Symptomatic Severe Aortic Stenosis
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk
The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN XT transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic…
- Trial name
- PII A (NCT01314313)
- Testing
- TAVR Implantation with SAPIEN XT, SAVR Implantation
- Where
- 57 sites in United States, Canada
- Volunteers
- 2,032 people
- Sponsor
- Edwards Lifesciences
Hypertrophic Cardiomyopathy
Exercise Intolerance in Non-obstructive Hypertrophic Cardiomyopathy
The EXCITE-HCM study is a randomized, controlled, blinded clinical trial designed to evaluate the effect of moderate intensity exercise training versus usual physicial activity on the improvement of HCM-related symptoms and…
- Trial name
- EXCITE-HCM (NCT05818605)
- Testing
- Moderate Intensity Exercise Program
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- University of California, San Francisco
Transcatheter Aortic Valve Replacement (TAVR), Aortic Valve Stenosis
Patient Quality of Recovery After TAVR With Different Sedation Regimens
The goal of this clinical trial is to learn whether the type of sedation medication used during a transcatheter aortic valve replacement (TAVR) affects how people recover after the procedure.
- Trial name
- NCT07556523
- Testing
- Propofol, Dexmedetomidine, Midazolam
- Where
- United States
- Volunteers
- 126 people
- Sponsor
- David Lyubashevsky
Bicuspid Aortic Valve
Bicuspid Aortic Valve (BAV) Registry
The purpose of this registry is to gather information on patients with bicuspid aortic valve disease.
- Trial name
- BAV (NCT01756222)
- Where
- United States
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- University of Michigan
HCM - Hypertrophic Cardiomyopathy, Sudden Cardiac Death
Left Bundle Branch Pacing in Patients With Hypertrophic Cardiomyopathy After Myectomy
Pilot interventional randomized clinical trial to study the efficacy of left bundle branch pacing in patients with hypertrophic cardiomyopathy after myectomy for the prevention of progression of heart failure, prevent the…
- Conditions
- HCM - Hypertrophic Cardiomyopathy, Sudden Cardiac Death, Left Bundle Branch Pacing, ICD
- Trial name
- LEFTpaceHCM (NCT07372196)
- Testing
- ICD with left bundle branch area pacing (LBBAP), dual-chamber ICD
- Where
- Russia
- Volunteers
- 30 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Aortic Valve Stenosis
Impact of Local Tissue Inflammation on Intramyocardial Conduction Pathways Post Percutaneous Valve : Evaluation by Positron Emission Tomography on Exploratory Cohort
Aortic valve stenosis is the most common valve disease leading to surgical or percutaneous intervention in Europe and North America.
- Trial name
- IMPACT (NCT05308888)
- Testing
- 18F-FDG PET-CT
- Where
- France
- Volunteers
- 100 people
- Sponsor
- University Hospital, Brest
Neurodevelopmental Disorders, Neurodevelopmental Disorders (NDD)
Intensive Multimodal Neurorehabilitation Targeting Neuroplasticity in Pediatric Neurodevelopmental and Chromosomal Disorders
This observational study evaluates functional and developmental outcomes in pediatric participants undergoing a two week intensive multimodal neurorehabilitation program.
- Conditions
- Neurodevelopmental Disorders, Neurodevelopmental Disorders (NDD), Neurodevelopmental Disorders and Developmental Abnormalities, Developmental Delay (Disorder)
- Trial name
- GEN-HOPE (NCT07493096)
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Healing Hope International
Symptomatic Degenerative Aortic Stenosis, Severe Aortic Stenosis
CONFIDENCE Registry to Assess Safety and Performance of Portico System to Treat Patients With Severe Aortic Stenosis.
The purpose of this clinical investigation is to characterize the procedural safety and device performance of transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in patients with symptomatic degenerative…
- Trial name
- NCT03752866
- Testing
- Portico™ Valve, Portico Delivery System(s) and Loading System(s), Portico™ Valve, FlexNav Delivery System(s) and Loading System(s)
- Where
- 28 sites in Australia, Belgium and 7 more
- Volunteers
- 1,001 people
- Sponsor
- Abbott Medical Devices
Vascular Calcification, Chronic Kidney Diseases
a-Klotho in Relation to Calcification in the Coronary Arteries and Aortic Valve in Patients With Chronic Kidney Disease
To define the correlation of the levels of a-Klotho with the severity of vascular calcification in the coronary arteries and aortic valve.
- Trial name
- NCT03858413
- Testing
- No intervention
- Volunteers
- 60 people
- Sponsor
- Royal Brompton & Harefield NHS Foundation Trust
Williams Syndrome
Vitamin D Metabolism and the Williams Syndrome
The Williams syndrome is a disease in which supravalvular aortic stenosis, an elfin facies, mental retardation and other congenital defects are sometimes associated with abnormal vitamin D and calcium metabolism.
- Trial name
- NCT00013962
- Testing
- Vitamin D
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- National Center for Research Resources (NCRR)
Aortic Regurgitation Disease
Aspirin Monotherapy Versus Sequential Warfarin-Aspirin Therapy After TAVR in Patients With Pure Aortic Regurgitation
This multicenter randomized controlled trial evaluates antithrombotic strategies post-TAVR in severe aortic regurgitation patients without long-term anticoagulation.
- Trial name
- AWATAR (NCT07677410)
- Testing
- Aspirin, Warfarin
- Where
- China
- Volunteers
- 1,172 people
- Sponsor
- Shanghai Zhongshan Hospital
Peripheral Artery Disease, Coronary Disease
Evaluation of Patients With Known or Suspected Heart Disease
In this study researchers will admit and evaluate patients with known or suspected heart disease referred to the Cardiology Branch of the National Heart, Lung, and Blood Institute (NHLBI).
- Conditions
- Peripheral Artery Disease, Coronary Disease, Diabetes and Heart Failure, Dilated Cardiomyopathy
- Trial name
- NCT00001313
- Where
- 2 sites in United States
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Aortic Stenosis
Feasibility Study of the transShield Embolic Protection System
The objective of this study is to evaluate the initial safety and performance of the transShield EPS used for embolic protection during Transcatheter Aortic Valve Replacement (TAVR).
- Trial name
- NCT06652841
- Testing
- transShield Embolic Protection System
- Where
- New Zealand
- Volunteers
- 2 people
- Sponsor
- TransAortic Medical, Inc.
Myocardial Infarction (MI), Hypertrophic Cardiomyopathy (HCM)
The Application of T1 Mapping in Real-World
The goal of this observational study is to create a comprehensive real-world spectrum of T1 mapping measurements across different heart conditions.
- Conditions
- Myocardial Infarction (MI), Hypertrophic Cardiomyopathy (HCM), Dilated Cardiomyopathy (DCM), Arrhythmogenic Cardiomyopathy
- Trial name
- NCT07354646
- Testing
- Magnetic Resonance Imaging with Contrast
- Where
- China
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
Aortic Valve Stenosis
REPRISE EDGE 29 mm EU Study
The objective of the REPRISE EDGE 29 mm EU study is to evaluate performance and safety of the 29 mm LOTUS Edge™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe native…
- Trial name
- NCT02964962
- Testing
- 29 mm LOTUS Edge™ Valve System
- Sponsor
- Boston Scientific Corporation
Aorta Aneurysm, Aorta Dissection
Spanish Percutaneous Aortic INtervention REGISTRY (SPAIN REGISTRY)
Multicentre prospective registry including consecutive patients undergoing Percutaneous Endovascular Aneurysm Repair (PEVAR), Percutaneous Endovascular Thoracic Aneurysm Repair (PTEVAR) or Transcatheter Aortic Valve Implantation…
- Conditions
- Aorta Aneurysm, Aorta Dissection, Aorta Stenosis, Aortic Coarctation
- Trial name
- SPAIN (NCT04307888)
- Testing
- Perclose Proglide (Abbott)
- Volunteers
- 600 people
- Sponsor
- Sociedad Espanola de Angiologia y Cirugia Vascular