Clinical trials: Aortic Valve Replacement
This Study is Being Conducted to Collect Echocardiographic Data to Test the Lumify Ultrasound With Hemodynamic Automation Device
Testing Automated Echocardiography
The purpose of this research is to determine if software can accurately predict certain heart parameters from chest wall ultrasound (non-radiation, non-invasive, imaging modality).
- Trial name
- NCT04943965
- Testing
- Ultrasound imaging
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- University of Pennsylvania
Myocardial Function of the Stenosis Aortic Valve Before and Beyond Valve Replacement
Myocardial Function of the Setonis Aortic Valve Before and Beyond Valve Replacement
Study the consequences on heart muscle of the stenosis aortic valve before and after the replacement procedure, the repercussion on heart.
- Trial name
- AOMYOC (NCT03686527)
- Testing
- stenosis aortic valve
- Where
- France
- Volunteers
- 277 people
- Sponsor
- Rennes University Hospital
Severe Symptomatic Calcified Native Aortic Valve Stenosis
Cerebral Protection in Transcatheter Aortic Valve Replacement
The Sentinel System will be a safe and effective method for capturing and removing embolic material (thrombus/debris) during transcatheter aortic valve replacement in order to reduce the ischemic burden in the cerebral anterior…
- Trial name
- NCT02214277
- Testing
- Cerebral Protection System-The SENTINEL System with TAVR, TAVR
- Where
- 15 sites in United States, Germany
- Volunteers
- 363 people
- Sponsor
- Claret Medical
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, Transcatheter Aortic Valve Implantation
Feasibility, Safety, and Effectiveness of the ACURATE neo2 Transcatheter Heart Valve for Severe Bicuspid Aortic Stenosis
The goal of the NEO2 BAV registry is to investigate the safety, effectiveness, and clinical performance of TAVI using the ACURATE neo2 valve in patients with severe BAV stenosis.
- Conditions
- Aortic Stenosis, Transcatheter Aortic Valve Implantation, Bicuspid Aortic Valve, Transcatheter Aortic Valve Replacement
- Trial name
- Neo2BAV (NCT06212050)
- Testing
- Transcatheter Aortic Valve Implantation
- Where
- 3 sites in Germany, Ireland and 1 more
- Volunteers
- 200 people
- Sponsor
- National University of Ireland, Galway, Ireland
Aortic Valve Stenosis
Inspiris Resilia Durability Registry
Prospective, open-label, multicenter, European registry with a follow-up of 5 years to assess the clinical outcomes of patients younger than 60 years who undergo surgical AVR with the INSPIRIS RESILIA Aortic Valve™.
- Trial name
- INDURE (NCT03666741)
- Testing
- AVR with or without CABG
- Where
- 21 sites in Austria, Belgium and 7 more
- Volunteers
- 400 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
Aortic Stenosis, Coronary Artery Disease
Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial
The primary objective of this study is to compare, in patients with severe aortic stenosis and concomitant coronary artery disease accepted for transcatheter aortic valve implantation (TAVI) and percutaneous coronary intervention…
- Conditions
- Aortic Stenosis, Coronary Artery Disease, TAVI, PCI
- Trial name
- TAVI-PCI (NCT04310046)
- Testing
- PCI before TAVI, PCI after TAVI
- Where
- 48 sites in Austria, France and 4 more
- Volunteers
- 986 people
- Sponsor
- University of Zurich
Aortic Valve Stenosis, Cardiovascular Diseases
The Nordic Aortic Valve Intervention Trial 4 (NOTION-4)
A randomized clinical trial investigating the incidence and temporal dynamics of subclinical leaflet thickening by cardiac CT in transcatheter bioprosthetic aortic valves in patients randomised to different anti-thrombotic…
- Conditions
- Aortic Valve Stenosis, Cardiovascular Diseases, Heart Diseases, Heart Valve Diseases
- Trial name
- NOTION-4 (NCT06449469)
- Testing
- Rivaroxaban, Acetylsalicylic acid, Clopidogrel
- Where
- 2 sites in Denmark
- Volunteers
- 352 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Severe Aortic Stenosis, Transcatheter Aortic Valve Replacemen
Alwide Plus China Post-market Clinical Investigation
This is a prospective, single-arm, multi-center, post-market registry study conducted in China. The purpose is to evaluate the safety and effectiveness of the AlwideTM Plus balloon catheter for pre-dilatation of the aortic valve…
- Trial name
- NCT07304427
- Where
- 4 sites in China
- Volunteers
- 75 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Aortic Stenosis, Transcatheter Aortic Valve Replacement
EffecTAVI Registry
Aortic stenosis (AS) is the most common valvular heart disease among elderly population, with a increasing prevalence due to population ageing.
- Conditions
- Aortic Stenosis, Transcatheter Aortic Valve Replacement, TAVI
- Trial name
- NCT05235555
- Testing
- Transcatheter heart valve (THV) with CE approval
- Where
- Italy
- Volunteers
- 1,000 people
- Sponsor
- Federico II University
Degenerative Aortic Valve Stenosis
The Effect of Transaortic Valve Replacement on the Endothelial Integrity and Function
Degenerative aortic valve stenosis (AVS) is the leading cause of aortic valve morbidity with a prevalence of 2-7% at ages above 65 years, with ever-increasing incidence especially in the 8th decades.
- Trial name
- NCT01993485
- Where
- Germany
- Volunteers
- 61 people
- Sponsor
- Heinrich-Heine University, Duesseldorf
Transcatheter Aortic Valve Replacement, Procedural Sedation
Comparison of Procedural Sedation With Propofol and Dexmedetomidine During Transcatheter Aortic Valve Implantation
Aortic valve stenosis is the most common valvular heart disease in the developed world, affecting 3,9% of population over 70 years of age.
- Trial name
- NCT03747432
- Testing
- Propofol, Dexmedetomidine
- Where
- Slovenia
- Volunteers
- 70 people
- Sponsor
- University Medical Centre Ljubljana
Aortic Valve Disorder
Frequency of Reduced Leaflet Motion After Surgical Aortic Valve Replacement and Transcatheter Aortic Valve Replacement.
This is a prospective, randomized pilot study in patients undergoing Sugical Aortic Valve Replacement (SAVR) and Transcatheter Aortic Valve Replacement (TAVR) to estimate the incidence of reduced leaflet motion and assess the…
- Trial name
- NCT02696226
- Testing
- SAVR Warfarin, SAVR Aspirin, TAVR Warfarin and clopidogrel
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- The Cleveland Clinic
Aortic Valve Stenosis, Heart Valve Diseases
ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation
The objective of ENVISION is to evaluate the safety and effectiveness of the Navitor Transcatheter Aortic Valve Implantation (TAVI) System for treating patients with symptomatic, severe native aortic stenosis who are considered…
- Conditions
- Aortic Valve Stenosis, Heart Valve Diseases, Aortic Valve Disease, Heart Disease Structural Disorder
- Trial name
- ENVISION (NCT05932615)
- Testing
- Navitor Transcatheter Aortic Valve Implantation (TAVI) System, Any Commercially Available Transcatheter Aortic Valve (CAV) System
- Where
- 107 sites in United States, Australia and 11 more
- Volunteers
- 1,500 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Stenosis
Perioperative Hemodynamic and Microcirculatory Physiological Study During TAVI
The Physiological Study of Haemodynamic and Microcirculatory Evolution before/after Transcatheter Aortic Valve Replacement (TAVI) aims to investigate the physiological changes induced by the implantation of a prosthetic aortic…
- Trial name
- TAVI (NCT06154642)
- Testing
- Determination of arterial compliance using blood pressure waveform analysis, Measurement of plasma Vascular Endothelium Growth Factor, Skin temperature gradient
- Where
- Switzerland
- Volunteers
- 21 people
- Sponsor
- University Hospital, Geneva
Aortic Valve Stenosis
Anticoagulant Versus Dual Antiplatelet Therapy for Preventing Leaflet Thrombosis and Cerebral Embolization After Transcatheter Aortic Valve Replacement
This trial is to compare the efficacy of NOAC(Novel Oral Anticoagulants) with edoxaban vs. dual antiplatelet therapy (DAPT) for prevention of leaflet thrombosis (documented by cardiac CT imaging) and cerebral embolization…
- Trial name
- ADAPT-TAVR (NCT03284827)
- Testing
- NOAC, DAPT
- Where
- 5 sites in Hong Kong, South Korea and 1 more
- Volunteers
- 235 people
- Sponsor
- Duk-Woo Park, MD
Severe Aortic Valve Stenosis
Validation of Accurate Commissural Alignment During Transcatheter Aortic Valve Implantation
Background: Transcatheter aortic valve replacement (TAVR) has become the preferred therapy for aortic stenosis. Given the growing life-expectancy, the risk of requiring coronary interventions or of developing prosthesis…
- Trial name
- ACA (NCT05097183)
- Testing
- Accurate Commissural Alignment (ACA)
- Where
- 15 sites in Spain
- Volunteers
- 274 people
- Sponsor
- Ignacio J. Amat Santos
Heart Block, Aortic Stenosis
Glucocorticoid Treatment in Transaortic Valve Replacement to Reduce the Incidence of Conduction Disturbances (GLUCO-TAVR).
The goal of this phase IV, randomized, controlled and open-label study is to assess the efficacy of peri-procedure glucocorticoid treatment in the prevention of conduction abnormalities and the need for pacemaker implantation in…
- Conditions
- Heart Block, Aortic Stenosis, Bundle-Branch Block
- Trial name
- GLUCO-TAVR (NCT06076824)
- Testing
- Methylprednisolone
- Where
- Spain
- Volunteers
- 100 people
- Sponsor
- Hospital General Universitario de Alicante
Aortic Stenosis
PRessure-based Evaluation of Disease Improvement in the Course of TAVI
The goal of this prospective observational study is to learn if advanced heart pressure wave analysis (using methods called WIA and REPA) can help predict the success of the procedure and long-term recovery in adults (aged 60-90)…
- Trial name
- PREDIC-TAVI (NCT07509554)
- Testing
- Transcatheter aortic valve replacement (TAVR / TAVI)
- Where
- Turkey (Türkiye)
- Volunteers
- 100 people
- Sponsor
- Istanbul Mehmet Akif Ersoy Educational and Training Hospital
Aortic Valve Stenosis, Arrhythmia
Electrophysiological Outcomes After Transcatheter Aortic Valve Replacement
The TAVR-ELECTRO Registry (Electrophysiological Outcomes After Transcatheter Aortic Valve Replacement) is a single-center, observational cohort study designed to systematically evaluate the occurrence, temporal evolution, and…
- Trial name
- TAVR-ELECTRO (NCT07390513)
- Testing
- TAVR Aspirin and clopidogrel
- Where
- China
- Volunteers
- 1,000 people
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital