Clinical trials: Aorta Disease
Thoracic Aortic Dissection
DISSECT-N Post Market Data Collection Registry
DISSECT-N is a post-market registry designed to assess real-world safety and effectiveness of Valiant Navion Thoracic Stent Graft System in the treatment of thoracic aortic dissections in real world practice.
- Trial name
- DISSECT-N (NCT04267055)
- Testing
- Valiant Navion Thoracic Stent Graft System
- Where
- 22 sites in United States, Denmark and 8 more
- Volunteers
- 102 people
- Sponsor
- Medtronic Cardiovascular
Aortic Valve Stenosis, Aortic Valve Calcification
REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve SystEm
This is a prospective, single-arm feasibility study designed to assess the acute safety and performance of the Lotus Valve System for transcatheter aortic valve replacement in symptomatic patients with calcified aortic valve…
- Conditions
- Aortic Valve Stenosis, Aortic Valve Calcification, Aortic Valve Disease
- Trial name
- REPRISE I (NCT01383720)
- Testing
- Lotus Valve System
- Where
- 3 sites in Australia
- Volunteers
- 11 people
- Sponsor
- Boston Scientific Corporation
Abdominal Aortic Aneurysm
LUCY Study: TriVascular Evaluation of Females Who Are Underrepresented Candidates for Abdominal Aortic Aneurysm Repair
The LUCY Study is a prospective, consecutively enrolling, non-randomized multi center post-market registry to evaluate the low profile Ovation ® Abdominal Stent Graft Platform when used in the endovascular treatment of female…
- Trial name
- LUCY (NCT02479191)
- Testing
- Ovation Abdominal Stent Graft Platform
- Where
- United States
- Volunteers
- 225 people
- Sponsor
- TriVascular, Inc.
Aortic Stenosis, Severe
All Women Comparing Self-expanding ALLEGRA Valve to Any Other Balloon-expandable Valve
Study is aimed to demonstrate that the self-expandable Allegra TAVI system provides lower mean gradient assessed by TTE compared to balloon-expandable valve systems in a female patient population with symptomatic severe aortic…
- Trial name
- NCT05989074
- Testing
- ALLEGRA TAVI System TF, Ballon-expandable valve system
- Volunteers
- 130 people
- Sponsor
- Ceric Sàrl
Hypertrophic Cardiomyopathy
Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in PIONEER
This is a multicenter open-label study of the administration of mavacamten in participants with symptomatic obstructive HCM (oHCM) who previously participated in study MYK-461-004 (PIONEER-HCM).
- Trial name
- PIONEER-OLE (NCT03496168)
- Testing
- mavacamten
- Where
- 4 sites in United States
- Volunteers
- 13 people
- Sponsor
- Bristol-Myers Squibb
Aortic Valve Stenosis
Engager Direct Aortic Clinical Study
To confirm the safety and performance of the Medtronic Engager™ Transcatheter Aortic Valve Implantation System via direct aortic approach.
- Trial name
- NCT01789567
- Testing
- Engager™ aortic valve
- Where
- 6 sites in Czechia, Germany and 1 more
- Volunteers
- 20 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Carotid Stenosis
Gadobutrol Enhanced MRA of the Supra-aortic Vessels
Subjects referred for a routine CTA (computed tomography angiography) or MRA (magnetic resonance angiography) will be invited to participate in the study and subjects will be involved in the study for between 2 and 12 days.
- Trial name
- GEMSAV (NCT01344447)
- Testing
- Gadobutrol (Gadovist, BAY86-4875)
- Where
- 56 sites in United States, Argentina and 12 more
- Volunteers
- 479 people
- Sponsor
- Bayer
Atrial Fibrillation
Edoxaban Compared to Standard Care After Heart Valve Replacement Using a Catheter in Patients With Atrial Fibrillation (ENVISAGE-TAVI AF)
When the upper chambers of a person's heart receive or generate irregular electrical signals, it causes abnormal rhythm in the heartbeat. This is called atrial fibrillation.
- Trial name
- NCT02943785
- Testing
- Edoxaban-based Regimen, VKA-based Regimen
- Where
- 230 sites in United States, Austria and 12 more
- Volunteers
- 1,426 people
- Sponsor
- Daiichi Sankyo
Abdominal Aortic Aneurysms
China Post-market Study of the INCRAFT® AAA Stent Graft System in Subjects With Abdominal Aortic Aneurysms (INITIATION)
INITIATION is a postmarket clinical follow-up study in China. The purpose of the study is to continue to evaluate the safety and effectiveness/performance of Incraft in subjects with abdominal aortic aneurysms requiring…
- Trial name
- NCT03965364
- Testing
- INCRAFT
- Where
- China
- Sponsor
- Cordis US Corp.
Aortic Valve Disease, Aortic Stenosis
Sorin Universal REgistry on Aortic Valve Replacement
Multi-center, International, Prospective, Non comparative, Non randomized, Open label. 5,000 patients to be enrolled approximately worldwide.
- Trial name
- SURE-AVR (NCT02679404)
- Where
- 52 sites in United States, Australia and 15 more
- Volunteers
- 2,758 people
- Sponsor
- Corcym S.r.l
Thoracic Aortic Aneurysms
VALOR: The Talent Thoracic Stent Graft System Clinical Study
A Descending Thoracic Aneurysm is a bulge in the aorta. The aorta is a large blood vessel that carries blood away from your heart to organs in the rest of your body. Your aneurysm is caused by a weakening in the artery wall.
- Trial name
- VALOR (NCT00604799)
- Testing
- Talent Thoracic Stent Graft
- Where
- United States
- Volunteers
- 379 people, healthy volunteers welcome
- Sponsor
- Medtronic Cardiovascular
Aneurysm Abdominal, Peripheral Aneurysms
A Retrospective, Observational Study to Collect Clinical Safety and Performance Data of POLYMAILLE® EXTRA THIN Vascular Prothesis
The purpose of this PMCF study is to evaluate a minimum of 125 subjects in 1 or 2 sites in France at least 1-year follow-up after surgery until a maximum of 5 years in the indication of abdominal and peripheral arterial surgery…
- Conditions
- Aneurysm Abdominal, Peripheral Aneurysms, Arterial Disease Occlusive, Prothesis
- Trial name
- NCT05519826
- Testing
- Vascular surgery
- Where
- France
- Volunteers
- 373 people
- Sponsor
- Perouse Medical
Hypertrophic Cardiomyopathy (HCM), Cardiac Imaging
ENABLE-HCM - AI-ENabled Echocardiography With Ultrasound Beyond the Echo Lab for Better HCM Imaging and Expanded Access
This study evaluates whether healthcare providers without specialized ultrasound training can use UltraSight's machine learning based Guidance Software to perform limited transthoracic echocardiography in patients with…
- Conditions
- Hypertrophic Cardiomyopathy (HCM), Cardiac Imaging, Echocardiography, Mavacamten
- Trial name
- NCT07155434
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- UltraSight
Aortic Stenosis
ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement
To evaluate safety and effectiveness of the ACURATE Transfemoral Aortic Valve System for transcatheter aortic valve replacement (TAVR) in subjects with severe native aortic stenosis who are indicated for TAVR.
- Trial name
- NCT03735667
- Testing
- ACURATE neo2™ Transfemoral TAVR System, Medtronic CoreValve TAVR System, Edwards SAPIEN 3 TAVR System
- Where
- 75 sites in United States, Canada
- Volunteers
- 1,948 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation, Stroke
Philips Intracardiac Echocardiography (ICE) Clinical Registry
The purpose of this observational registry is to report real-world safety and performance of VeriSight for ultrasound guided ICE imaging in percutaneous cardiac intervention procedures when used in standard clinical practice.
- Conditions
- Atrial Fibrillation, Stroke, Valve Disease, Heart, Atrial Septal Defect
- Trial name
- NCT04950192
- Testing
- ICE Image guidance
- Where
- 5 sites in United States
- Volunteers
- 155 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Aortic Valve Stenosis
Hydra Single-centre Experience - Copenhagen, Denmark
The present study aims to evaluate the efficacy and safety of TAVI using the Hydra transcatheter aortic valve (THV) series, in patients with severe aortic stenosis up to 1-year after the procedure.
- Trial name
- NCT06342635
- Testing
- Hydra Transcatheter Aortic Valve (THV) Series
- Where
- Denmark
- Volunteers
- 50 people
- Sponsor
- Sahajanand Medical Technologies Limited
Abdominal Aortic Aneurysm
TriVascular Evaluation of Females Who Are Underrepresented Candidates for Abdominal Aortic Aneurysm Repair in Europe
The LUCY Study is a prospective, consecutively enrolling, non-randomized multi center post-market study to evaluate the low profile (14F) Ovation® Abdominal Stent Graft Platform when used in the endovascular treatment of female…
- Trial name
- LUCY (NCT02703428)
- Where
- 10 sites in Belgium, Germany and 2 more
- Volunteers
- 30 people
- Sponsor
- TriVascular, Inc.
Coronary Arterial Disease (CAD), Arterial Stiffness
SCAPIS 2 Cardio - Vibrometer Based Pulse Wave Analysis and CVD Risk Assessment
This clinical investigation will evaluate a novel contactless technology for assessing arterial stiffness and pulse wave characteristics and explore its potential in assessment of coronary artery disease, aortic stenosis and…
- Conditions
- Coronary Arterial Disease (CAD), Arterial Stiffness, Aortic Valve Disease, Heart Failure
- Trial name
- NCT07001007
- Testing
- Coronary Computer Tomography (CCTA), Laser Doppler Vibrometry and single-lead ECG, Echocardiography
- Where
- Sweden
- Volunteers
- 1,600 people, healthy volunteers welcome
- Sponsor
- HJN Sverige AB/Neko Health
Abdominal Aortic Aneurysm
Zenith® AAA Endovascular Graft Clinical Study
The purpose of this study is to evaluate the safety and effectiveness of the Cook Zenith Endovascular Graft for the treatment of abdominal aortic (AAA), aortoiliac, and iliac aneurysms.
- Trial name
- NCT00196092
- Testing
- Roll-in, Surgical, Standard Risk
- Volunteers
- 819 people
- Sponsor
- Cook Group Incorporated
Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis
DurAVR™ THV System: EMBARK Study
A prospective, non-randomized, single-arm, single-center, first-in-human study designed to evaluate the safety and feasibility of the DurAVR™ THV System in the treatment of subjects with symptomatic severe aortic stenosis.
- Conditions
- Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis, Aortic Valve Calcification
- Trial name
- NCT05182307
- Testing
- DurAVR™ THV System
- Where
- Georgia
- Volunteers
- 150 people
- Sponsor
- Anteris Technologies Ltd.