Clinical trials: Aortic Disease
Heart Valve Diseases
Clinical Investigation Of The Mitroflow Aortic Pericardial Heart Valve
This is a trial to demonstrate the safety and effectiveness of the Mitroflow Aortic Heart Valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.
- Trial name
- NCT00630916
- Testing
- Mitroflow Aortic Heart Valve
- Where
- 26 sites in United States, Canada
- Volunteers
- 756 people
- Sponsor
- Sorin Group USA, Inc.
Abdominal Aortic Aneurysm
Immediate Management of the Patient With Rupture : Open Versus Endovascular Repair
The purpose of this trial is to assess whether a strategy of endovascular repair (if aortic morphology is suitable, open repair if not) versus open repair reduces early mortality for patients with suspected ruptured abdominal…
- Trial name
- IMPROVE (NCT00746122)
- Testing
- Open repair, EVAR
- Where
- 30 sites in Canada, United Kingdom
- Volunteers
- 613 people
- Sponsor
- Imperial College London
Aortic Valve Stenosis
The SAPIEN 3 Ultra System in Intermediate Risk Patients With Symptomatic, Severe Aortic Stenosis
This study will confirm the procedural safety and performance of the SAPIEN 3 Ultra System in subjects with severe, calcific AS who are at intermediate operative risk for standard aortic valve replacement.
- Trial name
- NCT03471065
- Testing
- SAPIEN 3 Ultra Delivery System with the SAPIEN 3 Ultra THV
- Where
- 6 sites in Canada, United Kingdom
- Volunteers
- 100 people
- Sponsor
- Edwards Lifesciences
Aortic Stenosis, Coronary Artery Disease
COronary and MICrocirculatory Measurements in Patients With Aortic Valve Stenosis.
Although concomitant coronary artery disease (CAD) is frequent in patients with severe aortic stenosis (AS), hemodynamic assessment of CAD severity in patients undergoing valve replacement for severe AS is challenging.
- Trial name
- COMIC-AS (NCT04420325)
- Where
- 3 sites in Belgium
- Volunteers
- 116 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Aortic Stenosis
Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement
The objective of this study is to evaluate the safety and effectiveness of the Lotus™ Valve System and LOTUS Edge™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe…
- Trial name
- REPRISE III (NCT02202434)
- Testing
- Lotus Valve System, CoreValve/Evolut R Transcatheter Aortic Valve Replacement System, LOTUS Edge Valve System
- Where
- 58 sites in United States, Australia and 4 more
- Volunteers
- 1,425 people
- Sponsor
- Boston Scientific Corporation
Aortic Insufficiency
The HAART 300 Annuloplasty Ring Trial Extended Safety and Performance
This investigation is a prospective, non-randomized, multi-center trial to evaluate the extended safety and performance of the HAART model 300 annuloplasty ring when used to surgically repair the aortic valve using a 3-D…
- Trial name
- NCT01732835
- Testing
- HAART 300 Annuloplasty Device
- Where
- 8 sites in Czechia, Germany
- Volunteers
- 68 people
- Sponsor
- Biostable Science & Engineering
Abdominal Aortic Aneurysms
A Multicenter, Open Label, Prospective, Non-Randomized Study Of INCRAFT™ In Subjects With AAA (INNOVATION)
This study is a multi-center prospective, open label, non-randomized investigation of INCRAFT™ in subjects with abdominal aortic aneurysms. The study will enroll up to 60 subjects in up to 7 sites in Germany and Italy.
- Trial name
- INNOVATION (NCT01106391)
- Testing
- Cordis AAA stent graft system "INCRAFT TM"
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- Cordis US Corp.
Thoracoabdominal Aneurysm, Abdominal Aortic Aneurysm
Endovascular Exclusion of TAAA/AAA Utilizing Fenestrated/Branched Stent Grafts
The purpose of the study is to evaluate the role of fenestrated/branched stent-grafts in the exclusion of abdominal aortic and thoracoabdominal aneurysms.
- Trial name
- NCT00583050
- Testing
- Endovascular Aneurysm Repair
- Where
- United States
- Volunteers
- 1,366 people
- Sponsor
- The Cleveland Clinic
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
Abdominal Aortic Aneurysm
Percutaneous Endovascular Aneurysm Repair (PEVAR) Trial
To determine the safety and effectiveness of PEVAR.
- Trial name
- PEVAR (NCT01070069)
- Testing
- PEVAR (ProGlide closure), SEVAR (IntuiTrak), PEVAR (Prostar XL closure)
- Where
- 20 sites in United States
- Volunteers
- 192 people
- Sponsor
- Endologix
Takayasu's Arteritis, Giant Cell Arteritis
Abatacept for Treating Adults With Giant Cell Arteritis and Takayasu's Arteritis
Giant cell arteritis (GCA) and Takayasu's arteritis (TAK) are diseases that cause swelling of the arteries in the head, neck, upper body, and arms.
- Trial name
- NCT00556439
- Testing
- Abatacept
- Where
- 10 sites in United States, Canada
- Volunteers
- 97 people
- Sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Aortic Stenosis
Correlation of Auscultatory Severity of Aortic Stenosis With Trans Thoracic Echocardiography
According to the 2006 ACC/AHA practice guidelines for valvular heart disease, patients with asymptomatic aortic stenosis(AS) should have screening transthoracic echocardiograms (TTE) performed annually for severe disease, every…
- Trial name
- Cassette (NCT01605669)
- Testing
- Tranthoracic Echocardiogram, Cardiac Ascultation Recordings with Electronic stethoscope
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- United States Naval Medical Center, San Diego
Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)
Prevalence and Characteristics of Transthyretin Amyloidosis in Patients With Left Ventricular Hypertrophy of Unknown Etiology
The main purpose of this study is to determine the prevalence of ATTR Cardiomyopathy among patients admitted due to Left Ventricular Hypertrophy (LVH) >15mm of unknown etiology by using a 99mTc-tracer scintigraphy based protocol
- Trial name
- TTRACK (NCT03842163)
- Testing
- Diagnosis of TTR amyloidosis cardiomyopathy
- Where
- 18 sites in Australia, Austria and 8 more
- Volunteers
- 812 people
- Sponsor
- Pfizer
Aortic Dissection
ARISE: Evaluation of the GORE® Ascending Stent Graft in the Treatment of DeBakey Type I/II Aortic Dissection
Assess the feasibility of the treatment of DeBakey Type I/II aortic dissections with the GORE® Ascending Stent Graft
- Trial name
- NCT02380716
- Testing
- GORE® Ascending Stent Graft
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- W.L.Gore & Associates
Aortic Aneurysm, Thoracic, Chronic Type B Dissection
Evaluation of the Valiant Mona LSA Thoracic Stent Graft System in Descending TAA and Chronic Dissections
The purpose of the Feasibility study is to characterize the safety of the Valiant Mona LSA Thoracic Stent Graft System, including an assessment of the safety and effectiveness of the device acutely and at the 30 day visit in the…
- Trial name
- NCT02365467
- Testing
- Valiant Mona LSA Thoracic Stent Graft System
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Medtronic Cardiovascular
Marfan Syndrome
Effects of Losartan Versus Atenolol on Aortic and Cardiac Muscle Stiffness in Adults With Marfan Syndrome
Marfan syndrome is an inherited connective tissue disorder with morbidity and mortality from aortic dilation and dissection. The degree of aortic dilation and response to beta-blockade (standard of care) vary in adults with…
- Trial name
- NCT00723801
- Testing
- Atenolol, Losartan
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Brigham and Women's Hospital
Aortic Valve Stenosis
Clinical Evaluation of MDT-2111 in Subjects With Small Aortic Annuli and Symptomatic Severe Aortic Stenosis
The primary objective of the present trial is to demonstrate the safety and effectiveness of the MDT-2111 in the treatment of symptomatic severe aortic stenosis in subjects with small aortic annuli and deemed difficult for…
- Trial name
- NCT01634269
- Testing
- MDT-2111 TAVI 23 mm
- Where
- 4 sites in Japan
- Volunteers
- 20 people
- Sponsor
- Medtronic Cardiovascular
Abdominal Aortic Aneurysms
Physician-Sponsored IDE for Talent Endoluminal Spring Graft System in Patients With Abdominal Aortic Aneurysms (AAA)
The purpose of this study is to evaluate the safety and effectiveness of the Talent Endoluminal Spring Graft System, an investigational device, to treat abdominal aortic aneurysms (AAA).
- Trial name
- NCT00695253
- Testing
- Talent Endoluminal Spring Graft System
- Where
- United States
- Volunteers
- 49 people
- Sponsor
- Rodney A. White, M.D.
Abdominal Aortic Aneurysm
Suprarenal Proximal Cuff Study for Treatment of Abdominal Aortic Aneurysm
The use of a suprarenal extension device during the index AAA procedure to accommodate the patient's anatomy and to prevent or repair leakage.
- Trial name
- NCT00739401
- Testing
- Suprarenal Proximal Cuff Extension
- Where
- 8 sites in United States
- Volunteers
- 44 people
- Sponsor
- Endologix
Aortic Stenosis, Valvular Heart Disease
ADVANCE Direct Aortic Study
This study is intended to collect data regarding the clinical utility, safety and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in patients with severe symptomatic aortic valve…
- Trial name
- NCT01676727
- Testing
- CoreValve aortic valve
- Where
- 9 sites in Czechia, France and 4 more
- Volunteers
- 100 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure