Clinical trials: Aortic Valve Disease
Cardio-pulmonary Bypass, AORTIC VALVE DISEASES
Clinical Validation of a Novel Handsfree Doppler Ultrasound Device, RescueDoppler, in Adult Cardiac Surgery Patients
The goal of this study is to evaluate a new device called RescueDoppler (RD), which measures continuous blood flow in the common carotid artery. The device is handsfree and operator- independent.
- Conditions
- Cardio-pulmonary Bypass, AORTIC VALVE DISEASES, Coronary Arterial Disease (CAD), Aortic Aneurysm of the Proximal Arch
- Trial name
- RD_CPB (NCT06637540)
- Testing
- RescueDoppler
- Where
- 3 sites in Norway
- Volunteers
- 42 people
- Sponsor
- St. Olavs Hospital
Inflammation, Systemic Inflammatory Response Syndrome
Inflammatory Response in Aortic Valve Replacement
The study investigates inflammatory and antiinflammatory response in patients with severe aortic valve stenosis needing either surgical treatment (surgical aortic valve replacement) or interventional cardiology treatment…
- Conditions
- Inflammation, Systemic Inflammatory Response Syndrome, Thoracic Surgery, Aortic Valve Stenosis
- Trial name
- NCT02324140
- Testing
- Whole blood analysis
- Where
- Switzerland
- Volunteers
- 101 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Symptomatic Aortic Stenosis, Aortic Valve Stenosis
SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial
The purpose of this trial is to generate clinical evidence on valve safety and performance of self-expanding (SE) versus balloon-expandable (BE) transcatheter aortic valve replacement (TAVR) in subjects with a small aortic…
- Conditions
- Symptomatic Aortic Stenosis, Aortic Valve Stenosis, Aortic Valve Replacement
- Trial name
- SMART (NCT04722250)
- Testing
- Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems, Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems
- Where
- 92 sites in United States, Canada and 11 more
- Volunteers
- 1,103 people
- Sponsor
- Medtronic Cardiovascular
Amyloidosis
Prevalence and Significance of ATTR Aortic Valve Amyloidosis in Degenerative Aortic Stenosis
Cardiac amyloidosis is a restrictive cardiomyopathy with a potentially severe prognosis that can be life-threatening. It is linked in the vast majority of cases to a light chain deposition of immunoglobulin or transthyretin.
- Trial name
- RACAMYL (NCT04636684)
- Testing
- Proteomic analysis
- Where
- France
- Volunteers
- 100 people
- Sponsor
- University Hospital, Toulouse
Hypertrophic Cardiomyopathy, Heart Failure With Preserved Ejection Fraction
Use of SGLT2i in noHCM With HFpEF
This study aims to evaluate the impact of Sodium-dependent glucose transporters 2 inhibitor Empagliflozin on the exercise capacity,symptoms of heart failure, cardiac function, myocardial remodeling and quality of life of…
- Trial name
- NCT06401343
- Testing
- Empagliflozin 10 MG
- Where
- China
- Volunteers
- 94 people
- Sponsor
- China National Center for Cardiovascular Diseases
Aortic Valve Stenosis
Aortic Stenosis: Determinants of Progression, Severity and Left Ventricular Remodeling
Aortic stenosis (AS) is the most frequent valvulopathy in Western countries. The prevalence of AS is constantly increasing due to the aging of the population.
- Trial name
- AS-PROGRESSION (NCT03411317)
- Where
- France
- Volunteers
- 350 people
- Sponsor
- University Hospital, Rouen
Hypertrophic Obstructive Cardiomyopathy
Hyp Obst Cardiomyopathy
Hypertrophic Obstructive cardiomyopathy (HOCM) is the most common genetic cardiomyopathy, heterogeneous in phenotype and clinical course.
- Trial name
- NCT04329689
- Testing
- The Septal myectom
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Assiut University
AORTIC VALVE DISEASES, Aortic Regurgitation
TRanscAtheter TreatMent of PurE Aortic Regurgitation With VitaFlow Liberty System
This study is a prospective, multicenter, non-randomized controlled trial, planning to enroll 180 patients with pure native aortic regurgitation.
- Conditions
- AORTIC VALVE DISEASES, Aortic Regurgitation, Transcatheter Aortic Valve Replacement (TAVR)
- Trial name
- TRAMPERS (NCT06818084)
- Testing
- VitaFlow+GDMT, J-Valve+GDMT
- Where
- 4 sites in China
- Volunteers
- 120 people
- Sponsor
- Ruijin Hospital
Aortic Root Aneurysm, Aortic Regurgitation
Aortic Valve-sparing Root Replacement, According to the Inclusion Technique Described by Tirone David
Retrospective observational study of all patients undergoing aortic root surgery with aortic valve conservation, using the inclusion technique described by Tirone David, between January 1, 2004 and December 31, 2020, at six…
- Trial name
- AORTLANTIC (NCT05515848)
- Testing
- No intervention
- Where
- 5 sites in France
- Volunteers
- 529 people
- Sponsor
- Nantes University Hospital
Aortic Valve Stenosis, Stroke
Oxygenation of the Cerebrum and Cooling During Transcatheter Aortic Valve Implantation (TAVI) Procedures - Part II
The aim of this study is to assess the possible neuroprotective effects of cooling (targeted cooling of the brain to 33°C) during Transcatheter Aortic Valve Implantation (TAVI) procedures.
- Trial name
- NCT01822964
- Testing
- targeted brain cooling (33°C) by RhinoChill device
- Where
- 2 sites in Belgium
- Volunteers
- 30 people
- Sponsor
- Hasselt University
Low-gradient Aortic Stenosis, Aortic Stenosis
AI Assessment of Low-Gradient Aortic Stenosis Severity Based on Echocardiography
The purpose of this study is to evaluate the effectiveness of an artificial intelligence (AI) model developed by the investigators for identifying severe low-gradient aortic valve stenosis.
- Trial name
- ASAI-POL (NCT07144189)
- Testing
- AI diagnostic test for severe low-gradient aortic stenosis
- Where
- Poland
- Volunteers
- 300 people
- Sponsor
- National Institute of Cardiology, Warsaw, Poland
Infective Endocarditis
Characterization of RadiOlabeled Tracer Uptake Pattern in Noninfected Transcatheter Aortic Valves.
Therefore, the objective of the study is to characterize the pattern of radiolabeled tracer (18F-FDG) uptake in noninfected transcatheter heart valves in early follow-up after transcatheter aortic valve replacement (TAVR).
- Trial name
- COUNT (NCT03683355)
- Testing
- 18F-FDG PET/CT
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Coronary Artery Disease, Myocarditis
A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease
This study aims to identify and assess new CMR techniques that can improve current CMR protocols.
- Conditions
- Coronary Artery Disease, Myocarditis, Infiltrative Cardiomyopathy, Dilated Cardiomyopathy
- Trial name
- NCT04464655
- Where
- Canada
- Volunteers
- 2,130 people, healthy volunteers welcome
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Severe Aortic Valve Stenosis, High-degree AV Block
Infranodal Conduction Time During TAVR as Predictor of HAVB
Consecutive patients with high grade aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) with a self-expanding valve (Medtronic CoreValve Evolut R® or Edwards Sapien S3®) without pre-existing pacemaker…
- Conditions
- Severe Aortic Valve Stenosis, High-degree AV Block, Left Bundle-Branch Block
- Trial name
- HOM-TAVI (NCT04128384)
- Testing
- Limited electrophysiologic study including measurements of HV- and AH-intervals pre- and post-TAVR
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- University Hospital, Saarland
Aortic Valve Stenosis
Transapical Implantation of the Medtronic Engager Transcatheter Aortic Valve Implantation System - The Engager European Pivotal Trial
The purpose of the study is to evaluate the safety and clinical performance of the Engager Transcatheter Aortic Valve Implantation System in patients with severe aortic valve stenosis who are at high risk for surgical valve…
- Trial name
- NCT01348438
- Testing
- Medtronic Engager Transcatheter Aortic Valve Implantation System
- Where
- 9 sites in Belgium, Germany and 2 more
- Volunteers
- 125 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Aortic Stenosis
Association Between Changes in Aortic Valve Area and Pulmonary Congestion After Transcatheter Aortic Valve Implantation
This prospective, single-center observational study aims to evaluate the relationship between changes in aortic valve hemodynamics and pulmonary congestion in patients undergoing elective transfemoral transcatheter aortic valve…
- Trial name
- NCT07794436
- Testing
- Transcatheter Aortic Valve Implantation (TAVI)
- Where
- Turkey (Türkiye)
- Volunteers
- 52 people
- Sponsor
- Istanbul University - Cerrahpasa
Heart Diseases, Aortic Stenosis, Severe
EARLY TAVR: Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis
This study will evaluate the safety and effectiveness of the Edwards SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve (THV) compared with clinical surveillance (CS) in asymptomatic patients with severe, calcific aortic stenosis.
- Trial name
- EARLY TAVR (NCT03042104)
- Testing
- Edwards SAPIEN 3 / SAPIEN 3 Ultra THV
- Where
- 77 sites in United States, Canada
- Volunteers
- 901 people
- Sponsor
- Edwards Lifesciences
Aortic Stenosis, Transthyretin Amyloid Cardiomyopathy
Cardiac Amyloidosis in Patients With Aortic Stenosis
This study intends to conduct a prospective observation to investigate the prevalence of cardiac amyloidosis (CA) in patients with aortic stenosis (AS), compare the clinical characteristics between patients with isolated AS and…
- Trial name
- NCT07170306
- Testing
- transcatheter aortic valve replacement (TAVR)
- Volunteers
- 143 people
- Sponsor
- Shanghai Zhongshan Hospital
Aortic Valve Stenosis
PREVAIL-TA: Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe)
A single arm, prospective multicenter non-randomized confirmatory clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX; "study valve"), the next generation Ascendra™ transapical delivery…
- Trial name
- NCT01238835
- Testing
- SAPIEN XT™ Transapical aortic valve replacement
- Where
- 20 sites in Austria, France and 2 more
- Volunteers
- 220 people
- Sponsor
- Edwards Lifesciences
Hypertrophic Cardiomyopathy
Hypertrophic Cardiomyopathy Symptom Release by BX1514M
Hypertrophic cardiomyopathy (HCM) is the most frequent genetic cardiac disease characterized by an asymmetric hypertrophic. In two third of patients, an obstruction to blood ejection is observed within the left ventricle which is…
- Trial name
- Light-CARMIDO (NCT02590809)
- Testing
- Treatment BX1514M, Walk distance test, Exercise echocardiography
- Where
- France
- Volunteers
- 38 people
- Sponsor
- University Hospital, Bordeaux
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