Clinical trials: Aortic Disease
Valvular Heart Disease
The PROTEMBO C Trial
The PROTEMBO C Trial is an international, multi-center, single arm, non-inferiority study of the safety and performance of using the ProtEmbo System for cerebral embolic protection in subjects with severe native aortic valve…
- Trial name
- NCT04618718
- Testing
- cerebral embolic protection during TAVR
- Where
- 8 sites in Germany, Latvia and 1 more
- Volunteers
- 64 people
- Sponsor
- Protembis GmbH
Hypertension
Effect of the Fixed Dose Combination Amlodipine/Valsartan on Central Aortic Blood Pressure in Uncontrolled Essential Hypertension With Amlodipine 5 mg
Assess that for an equivalent brachial blood pressure (BP)lowering, a fixed dose combination amlodipine/valsartan based regimen reduces central aortic BP pressure to a larger extent than an atenolol/amlodipine combination based…
- Trial name
- EXPLOR (NCT00687973)
- Testing
- Valsartan/amlodipine 80/5 mg tablets, Amlodipine 5 mg capsules, Amlodipine 10 mg capsules
- Where
- France
- Volunteers
- 393 people
- Sponsor
- Novartis Pharmaceuticals
Aortic Dissection
Study to Evaluate the Clinical Performance of the Valiant Thoracic Stent Graft With the Captivia Delivery System (Valiant Captivia) for the Treatment of Acute, Complicated Type B Aortic Dissections
The purpose of this study is to determine if the Valiant stent graft is safe and effective in treating patients who have a thoracic dissection.
- Trial name
- NCT01114724
- Testing
- Valiant Thoracic Stent Graft with the Captivia Delivery System
- Where
- 17 sites in United States
- Volunteers
- 50 people
- Sponsor
- Medtronic Cardiovascular
Endovascular Repair of Infrarenal Abdominal Aortic Aneurysm Using Endovascular Stent Graft
Post-market European & Asian Registry to Evaluate the Minos™ Stent-Graft and Delivery System in Abdominal Aortic Aneurysm Treatment
The Minos™ Abdominal Aortic Stent-Graft and Delivery System is a medical device designed to treat abdominal aortic aneurysms using a minimally invasive procedure.
- Trial name
- PEARL (NCT07674173)
- Testing
- Implantation with Minos Stent graft
- Where
- 16 sites in China, Germany and 4 more
- Volunteers
- 200 people
- Sponsor
- Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd
Patients With an Indication for an Echocardiographic Examination With Suspicion of Valcular Heart Disease
Point-of-Care Echocardiography in Patients With Known or Suspected Aortic Stenosis
This is a prospective clinical trial intended to capture echocardiographic images in patients clinically indicated for an echocardiographic examination using an additional Point of Care Ultrasound device .
- Trial name
- POC (NCT06717373)
- Testing
- AutoAS
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- Caption Health, Inc.
Vascular Aneurysm
EASYII - E-tegra Stent Graft System - Imaging Cohort
The objective of the study is to assess the stent stability and durability as well as the seal of the stent graft during the cardiac cycle and over time as well as to evaluate safety and clinical performance of the E-tegra Stent…
- Trial name
- EASYII (NCT05586503)
- Testing
- ECG-gated CTAs
- Where
- 4 sites in Netherlands
- Volunteers
- 25 people
- Sponsor
- JOTEC GmbH
AORTIC VALVE DISEASES, Mitral Valve Disease
Early Feasibility Study of Surgical Implantation of a Polymer Prosthetic Mitral and Aortic Valve
The goal of this clinical trial is to explore the early feasibility, initial safety, and efficacy of surgical implantation of a polymer prosthetic heart valve in patients requiring either mitral valve replacement or aortic valve…
- Conditions
- AORTIC VALVE DISEASES, Mitral Valve Disease, Aortic Stenosis, Aortic Regurgitation
- Trial name
- POLYVALVE-FIH (NCT07097740)
- Testing
- Polymer Prosthetic Heart Valve
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Mitrassist Lifesciences Limited Co., Ltd.
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
Aortic Regurgitation
HLT® Meridian® TAVR Valve System Early Feasibility Study for Aortic Regurgitation
To evaluate the safety and performance of The Meridian® TAVR Valve in patients with severe aortic regurgitation who present at high risk for aortic valve replacement surgery.
- Trial name
- RIVAL - AR EFS (NCT05409378)
- Testing
- The HLT® Meridian® TAVR Valve (Meridian® with TriVentTM Anticalcification Treatment Valve and Pathfinder® Delivery System)
- Where
- 3 sites in United States
- Sponsor
- HLT Inc.
Aortic Valve Stenosis
Medtronic Evolut™ EXPAND TAVR I Feasibility Study
The purpose of the study is to obtain safety and effectiveness data of the Medtronic Evolut™ PRO+ TAVR System for the treatment of severe, asymptomatic aortic stenosis.
- Trial name
- NCT04639258
- Testing
- Medtronic Evolut™ PRO+ System
- Where
- 8 sites in United States, Australia and 3 more
- Volunteers
- 11 people
- Sponsor
- Medtronic Cardiovascular
Abdominal Aortic Aneurysm
TriVascular Canadian LIFE Study: Least Invasive Fast-Track EVAR (Endovascular Aneurysm Repair)
The primary objectives of the LIFE Study are to demonstrate the clinical cost and benefits associated with using the Ovation Prime Abdominal Stent Graft System under the least invasive conditions defined in the Fast-Track EVAR…
- Trial name
- NCT02451566
- Testing
- Ovation Prime Abdominal Stent Graft System
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- TriVascular, Inc.
Abdominal Aortic Aneurysm
ARBITER-II: Aorfix™ Bifurcated Safety and Performance Trial: Phase II, Angulated Vessels
To assess the safety and performance of Aorfix™ Stent Grafts in the treatment of Abdominal Aortic and Aorto-Iliac Aneurysm where a significant degree of vessel angulation exists at the neck of the aneurysm or in the common iliac…
- Trial name
- ARBITER-II (NCT00442065)
- Testing
- Aorfix™ Stent Grafts (AAA endovascular procedure)
- Where
- 6 sites in Czechia, Germany and 3 more
- Volunteers
- 30 people
- Sponsor
- Lombard Medical
Aortic Stenosis
Self-Centering Guide Catheter Feasibility Study
An evaluation of the feasibility of using the Self-Centering Guide Catheter to deliver a guide wire across a stenotic native aortic valve into the left ventricle.
- Trial name
- NCT02639494
- Testing
- Self-Centering Guide Catheter
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Boston Scientific Corporation
Aortic Valve Disease, Aortic Stenosis
EDWARDS INTUITY Valve System FOUNDATION Study
The purpose of this active post-market surveillance study is to confirm the safety and effectiveness of the EDWARDS INTUITY Valve System in the study population.
- Conditions
- Aortic Valve Disease, Aortic Stenosis, Rapid Deployment Valves
- Trial name
- FOUNDATION (NCT02338154)
- Where
- 27 sites in Austria, Denmark and 7 more
- Volunteers
- 516 people
- Sponsor
- Edwards Lifesciences
Valvular Heart Disease
Observational Study of Prosthetic Tissue Aortic and Mitral Heart Valve
This study is a multi-center, prospective, non-randomized, observational study. The objectives of this study are to confirm the clinical safety and efficacy of the SJM Epic valve.
- Trial name
- EPIC (NCT00329667)
- Testing
- EPIC
- Volunteers
- 761 people
- Sponsor
- Abbott Medical Devices
Abdominal Aortic Aneurysm, Endoleak
AneuFix - Prophylactic Sac Filling
This study is set up to assess the feasibility and safety of the clinical procedure using AneuFix in a prophylactic setting at the time of EVAR endograft implantation.
- Trial name
- NCT04307992
- Testing
- Prophylactic sac filling with AneuFix
- Where
- 3 sites in Netherlands
- Volunteers
- 20 people
- Sponsor
- TripleMed B.V.
Aortic Aneurysm, Aortic Dissection
Characterization of Aortic Tissue at Reoperation
This study will analyse factors contributing to cardiac re-operation to determine causative effects
- Trial name
- NCT02375542
- Where
- Italy
- Volunteers
- 11 people
- Sponsor
- CryoLife Europa
Symptomatic Severe Aortic Stenosis
Portico Next Generation Approval Study
The purpose of this clinical study is to evaluate the acute safety and effectiveness of the next-generation Navitor (Portico™ NG) Transcatheter Aortic Heart Valve as assessed by the rate of all-cause mortality at 30 days and the…
- Trial name
- NCT04011722
- Testing
- Portico™ NG (Navitor) Valve and FlexNav™ Delivery System, Navitor Titan Valve (35mm) Valve and Large FlexNav™ Delivery System
- Where
- 28 sites in United States, Australia and 3 more
- Volunteers
- 333 people
- Sponsor
- Abbott Medical Devices
Thoracic Aortic Aneurysm
South American Thoracic Stent-Graft Study
A prospective, non-randomized multi-center clinical evaluation of the performance of the TriVascular Thoracic Stent Graft System when used in the treatment of subjects with thoracic aortic aneurysms (TAA).
- Trial name
- NCT01082172
- Testing
- Implant Thoracic Stent Graft
- Where
- Chile
- Volunteers
- 2 people
- Sponsor
- TriVascular, Inc.
Aortic Valve Stenosis
Venus-Vitae Pivotal Study Smart-Align Study
The purpose is to evaluate the safety, effectiveness and performance of Venus-Vitae Transcatheter Heart Valve System in patients with severe aortic stenosis.
- Trial name
- NCT05991271
- Testing
- Venus-Vitae Transcatheter Heart Valve System
- Volunteers
- 150 people
- Sponsor
- Venus MedTech (HangZhou) Inc.