Clinical trials: Aortic Stenosis
Aortic Stenosis
SecOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in TAVI
Aim of the study is to demonstrate equivalence of second-generation self-expandable valves (CoreValve Evolut R) in comparison to second-generation balloon-expandable valves (Edwards Sapien 3) and of local anesthesia with…
- Trial name
- SOLVE-TAVI (NCT02737150)
- Testing
- CoreValve Evolut R, Edwards Sapien 3, Local anesthesia with conscious sedation
- Where
- Germany
- Volunteers
- 444 people
- Sponsor
- Helios Health Institute GmbH
Cardiac Valve Disease, Aortic Valve Stenosis
Remote ECG Monitoring of TAVI Patients
After surgery, patients who undergo transcatheter aortic valve implantation (TAVI) are at risk of developing cardiac arrhythmias such as heart blocks and atrial fibrillation.
- Trial name
- NCT03810820
- Testing
- mobile Cardiac Arrhythmia Diagnostics Service (m-CARDS)
- Where
- Canada
- Volunteers
- 240 people
- Sponsor
- Population Health Research Institute
Aortic Valve Stenosis, Aortic Valve Regurgitation
Hemodynamic Matched Comparison of the Balloon-Expandable Transcatheter Heart Valves Myval and Sapien-3 for the Treatment of Aortic Stenosis
Transcatheter aortic valve implantation (TAVI) is recommended for patients with severe aortic stenosis (AS) at high to intermediate surgical risk.
- Trial name
- MATCH-BALL (NCT04548726)
- Testing
- Sapien 3 Transcather Aortic Valve Implant, Myval Transcather Aortic Valve Implant
- Where
- 6 sites in Italy, Spain
- Volunteers
- 416 people
- Sponsor
- Ignacio J. Amat Santos
Aortic Stenosis, Aortic Valve Disease
Radial Versus Femoral Secondary Access During TAVI
The R-TAVI study is a randomized pilot study examining the use of the right radial artery versus the femoral artery for secondary vascular access during transcatheter aortic valve implantation (TAVI).
- Conditions
- Aortic Stenosis, Aortic Valve Disease, Vascular Access Complication
- Trial name
- R-TAVI (NCT03879824)
- Testing
- Secondary Radial Artery Access, Secondary Femoral Artery Access
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Carilion Clinic
Aortic Valve Stenosis
A Study Evaluating the Effects of Ataciguat (HMR1766) on Aortic Valve Calcification
The primary objective of the current study is to determine whether Ataciguat (HMR1766) slows progression of valve calcification in patients with moderate calcific aortic valve stenosis.
- Trial name
- CAVS (NCT02481258)
- Testing
- Ataciguat (HMR1766)
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Mayo Clinic
Coarctation of Aorta, Aortic Stenosis
Cardiac Remodeling and Circulating Biomarkers in Pediatric Left Ventricular Pressure Loading Lesions
This study is designed to learn more about children who have blockage of the left side of their heart. The goal is to determine how much the heart muscle has thickened before surgery and how it changes in the months after…
- Conditions
- Coarctation of Aorta, Aortic Stenosis, Cardiac Hypertrophy
- Trial name
- LVOTO (NCT02545790)
- Testing
- Echocardiogram, Serology
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- University of Colorado, Denver
Aortic Aneurysm, Iliac Aneurysm
Comparison of Aorto-iliac Endovascular Interventions With and Without the EndoNaut Workstation
The aim of this retrospective, multicenter study is to demonstrate that the use of EndoNaut for aortoiliac endovascular procedures has a clinical impact for the patient (reduction in irradiation and the volume of contrast…
- Conditions
- Aortic Aneurysm, Iliac Aneurysm, Stenoses, Aortic, Iliac Artery Stenosis
- Trial name
- COM-ENDO (NCT04714268)
- Testing
- Aorto-iliac endovascular procedure
- Where
- France
- Volunteers
- 150 people
- Sponsor
- Therenva
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
Aortic Stenosis Symptomatic, Aortic Valve Stenosis
Romanian National Registry of Outcomes After Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Stenosis - RO-TAVI
RO-TAVI is a national prospective, observational, multi-center registry registry of patients with aortic valve stenosis undergoing transcatheter aortic valve implantation (TAVI) to assess patient care and outcomes.
- Trial name
- RO-TAVI (NCT04694859)
- Testing
- Transcatheter Aortic Valve Implantation
- Where
- Romania
- Volunteers
- 500 people
- Sponsor
- Romanian Society of Cardiology
Aortic Stenosis
Cerebral Lesion and Neurocognitive Status Changes After TAVR
The CLEVER-TAVR cohort (Cerebral Lesion and Neurocognitive Status Changes after Transcatheter Aortic Valve Replacement) is a multicenter observational cohort study.
- Trial name
- CLEVER-TAVR (NCT04678934)
- Testing
- TAVR
- Where
- China
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Second Xiangya Hospital of Central South University
Aortic Stenosis
CHANGE Neo™ TA Registry With ACURATE Neo™ Aortic Bioprosthesis and ACURATE Neo™ TA Transapical Delivery System
The purpose of this registry is to collect specific health and patient data to identify more precisely the patient population undergoing TA aortic valve replacement with the ACURATE neo™ Aortic biprosthesis and ACURATE neo™ TA…
- Trial name
- NCT03454360
- Testing
- ACURATE neo™ Aortic Bioprosthesis
- Where
- 10 sites in Germany
- Volunteers
- 107 people
- Sponsor
- Symetis SA
Aortic Valve Stenosis
VitaFlow™ Transcatheter Aortic Valve System Pre-market Trial
This is a pre-market clinical investigation aiming to evaluate the safety and effectiveness of MicroPort™ CardioFlow VitaFlow™ Transcatheter Aortic Valve System for the treatment of severe aortic stenosis.
- Trial name
- NCT04655742
- Testing
- VitaFlow™ Transcatheter Aortic Valve System
- Where
- 4 sites in China
- Volunteers
- 120 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Aortic Valve Stenosis
Impact of SAVR and TAVR on Patient's Activity and Mobility
This is an independent, investigator-initiated, prospective multicenter observational study with restricted grant provided by Edwards Lifesciences that aims to describe baseline (preoperative) physical function and to assess and…
- Trial name
- CAPABILITY (NCT03843320)
- Testing
- SAPIEN 3, SAPIEN XT, INSPIRIS RESILIA
- Where
- 2 sites in Italy
- Volunteers
- 340 people
- Sponsor
- University of Padova
Aortic Valve Stenosis
Vascular Closure Device in Transcatheter Aortic Valve Replacement
Evaluation of the safety and efficacy of a percutaneous plug-based large-bore vascular closure device for femoral artery closure in an unselected consecutive patient cohort undergoing transcatheter aortic valve implantation in a…
- Trial name
- NCT04392492
- Testing
- MANTA vascular closure device
- Where
- Sweden
- Volunteers
- 1,000 people
- Sponsor
- Karolinska University Hospital
Platelet Function Tests, Predictive Value of Tests
Risk Stratification Post TAVI Using TEG
Transcatheter aortic valve implantation (TAVI) has become the standard of care in elderly patients at increased risk for surgical aortic valve replacement . However, the optimal antithrombotic strategy post TAVI is still unclear.
- Conditions
- Platelet Function Tests, Predictive Value of Tests, Thrombelastography, Cardiovascular Diseases
- Trial name
- RISTRATAVI (NCT03649594)
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- Torben Pottgiesser
Aortic Stenosis, Aortic Insufficiency
JUPITER Study: Transapical Aortic Valve Implantation for Aortic Regurgitation
The purpose of this registry is to observe longterm performance and safety of the JenaValve TAVI system, in routine medical and everyday conditions.
- Conditions
- Aortic Stenosis, Aortic Insufficiency, Aortic Regurgitation
- Trial name
- JUPITER (NCT01598844)
- Testing
- Transcatheter aortic valve replacement
- Where
- 15 sites in Germany, Netherlands and 2 more
- Volunteers
- 210 people
- Sponsor
- JenaValve Technology, Inc.
Ischemic Heart Disease, Coronary Artery Disease
Epitranscriptomic Blood Biomarkers for Coronary Artery Disease - A Prospective Cohort Study (IHD-EPITRAN)
Despite advancements in medical care, ischemic heart disease (IHD) remains the leading global cause of death. IHD develops through lipid accumulation into the coronary arteries with subsequent formation of larger atherogenic…
- Conditions
- Ischemic Heart Disease, Coronary Artery Disease, Aortic Valve Stenosis, Acute Myocardial Infarction
- Trial name
- IHD-EPITRAN (NCT04533282)
- Testing
- Blood samples., Collection of right atrial appendage tissue sample., Health Survey, Clinical symptom scaling
- Where
- Finland
- Volunteers
- 200 people
- Sponsor
- Hospital District of Helsinki and Uusimaa
Severe Aortic Stenosis, TAVI
Improved HRV, Inflammation Markers and Endothelial Function After TAVI
Severe aortic valve stenosis is known to affect heart haemodynamics, endothelial function and body inflammation markers. Our aim is to investigate the weather transcatheter aortic valve implantation in patients with severe aortic…
- Trial name
- bTAVI (NCT04286893)
- Testing
- Flow mediated vasodilatation, High resolution ECG, Blood withdrawal
- Where
- Slovenia
- Volunteers
- 50 people
- Sponsor
- University Medical Centre Ljubljana
Aortic Valve Stenosis
PREVAIL-TF: Transfemoral 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"), its transfemoral delivery system, and crimper…
- Trial name
- NCT00820599
- Testing
- Sapien XT™ transcatheter heart valve and delivery system
- Where
- 11 sites in Belgium, France and 2 more
- Volunteers
- 214 people
- Sponsor
- Edwards Lifesciences
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