Clinical trials: Aortic Diseases
Symptomatic Severe Aortic Stenosis
Early Feasibility Study (EFS) of Abbott's Balloon-expandable (BE) TAVI System for the Treatment of Severe, Symptomatic Aortic Stenosis
The purpose of this study is to evaluate the safety and functionality of Abbott's BE TAVI system for the treatment of patients with symptomatic severe aortic valve stenosis.
- Trial name
- NCT07116551
- Testing
- Abbott BE TAVI System
- Where
- 5 sites in United States, France
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Abbott Medical Devices
Hypertrophic Cardiomyopathy
Efficacy, Safety, and Tolerability of Perhexiline in Subjects With Hypertrophic Cardiomyopathy and Heart Failure
A Study on the Efficacy, Safety, and Tolerability of Perhexiline maleate in Subjects with Hypertrophic Cardiomyopathy and Moderate-To-Severe Heart Failure
- Trial name
- NCT02431221
- Testing
- Perhexiline
- Sponsor
- Heart Metabolics Limited
Abdominal Aortic Aneurysm
The Long-Term EVAR Assessment and Follow-Up (LEAF) Study for the AFX2 System
This is an observational, retrospective, multicenter study to evaluate the performance of the AFX2 System using real world evidence from VQI-VISION.
- Trial name
- LEAF (NCT06990048)
- Testing
- AFX2 System
- Where
- United States
- Volunteers
- 2,000 people
- Sponsor
- Endologix
Hypertrophic Cardiomyopathy
A Trial of HRS-1893 in Healthy Volunteers
The purpose of this study is to assess the safety and PK characteristics of a single oral dose of HRS-1893 in healthy voluunters.
- Trial name
- NCT07033455
- Testing
- HRS-1893
- Where
- Australia
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Atridia Pty Ltd.
Thoracic Aortic Aneurysm, Thoracic Aorta Injury
CTAG Dissection/Trauma Post Marketing Surveillance Japan
Post Marketing Surveillance of the Conformable GORE® TAG® Thoracic Endoprosthesis
- Conditions
- Thoracic Aortic Aneurysm, Thoracic Aorta Injury, Thoracic Aortic Dissection
- Trial name
- NCT05414318
- Testing
- Conformable GORE® TAG® Thoracic Endoprosthesis
- Volunteers
- 55 people
- Sponsor
- W.L.Gore & Associates
Abdominal Aortic Aneurysm
TriVascular Post-Market Registry
This is a prospective observational post-market study of subjects receiving the Ovation™ or Ovation Prime™ Abdominal Stent Graft System ("Ovation™ or Ovation Prime™ Abdominal Stent Graft System Post-Market Study") in the…
- Trial name
- NCT01372709
- Testing
- Ovation™ or Ovation Prime™ Abdominal Stent Graft System
- Where
- 30 sites in Austria, Belgium and 6 more
- Volunteers
- 501 people
- Sponsor
- TriVascular, Inc.
Abdominal Aortic Aneurysms
Endurant Bifurcated and Aorto-Uni-Iliac (AUI) Stent Graft System
To demonstrate safety and effectiveness of the Endurant Stent Graft in the treatment of Abdominal Aortic or Aorto-Uni-Iliac Aneurysms.
- Trial name
- NCT00705718
- Testing
- Endurant Stent Graft System
- Where
- 30 sites in United States
- Volunteers
- 194 people
- Sponsor
- Medtronic Cardiovascular
Aortic Stenosis
Feasibility Study of the transShield Embolic Protection System
The objective of this study is to evaluate the initial safety and performance of the transShield EPS used for embolic protection during Transcatheter Aortic Valve Replacement (TAVR).
- Trial name
- NCT06652841
- Testing
- transShield Embolic Protection System
- Where
- New Zealand
- Volunteers
- 2 people
- Sponsor
- TransAortic Medical, Inc.
Thoracic Aorta Aneurysm, Aneurysm, Ruptured
Early Feasibility Study of the RelayBranch Thoracic Stent-Graft System
The purpose of this study is to conduct an early clinical evaluation of the Relay Branch System, which will provide initial insight into the clinical safety and function of the device.
- Conditions
- Thoracic Aorta Aneurysm, Aneurysm, Ruptured, Aortic Aneurysm
- Trial name
- RelayBranch (NCT03214601)
- Testing
- penetrating atherosclerotic ulcer, aorta branch cardiovascular implant
- Where
- 12 sites in United States
- Volunteers
- 30 people
- Sponsor
- Bolton Medical
Cardiomyopathy, Hypertrophic, Cardiomyopathy, Hypertrophic, Familial
Open-Label Study of Perhexiline in Patients With Hypertrophic Cardiomyopathy and Moderate to Severe Heart Failure
The purpose of this study is to evaluate the effect of perhexiline on exercise performance (efficacy) and safety in patients with hypertrophic cardiomyopathy and moderate-to-severe heart failure following dosing for 16 weeks.
- Trial name
- NCT02862600
- Testing
- Perhexiline, Use of bioanalytical assay to monitor plasma levels of perhexiline
- Where
- 11 sites in United States
- Volunteers
- 35 people
- Sponsor
- Heart Metabolics Limited
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
Retinal Detachment, Achilles Tendon
A Study of Fluoroquinolones Exposure and Collagen-Related Serious Adverse Events
The purpose of this study is to evaluate whether there is an increased risk of achilles tendon rupture (ATR), retinal detachment (RD) or aortic aneurysm and dissection (AAD) following exposure to fluoroquinolone (FQ) or other…
- Conditions
- Retinal Detachment, Achilles Tendon, Aneurysm, Dissecting
- Trial name
- NCT03479736
- Testing
- Oral Fluoroquinolones (FQ), Other Antibiotics, Febrile Illness Not Treated with Antibiotics Will be Analyzed as an Exposure
- Where
- United States
- Volunteers
- 117,911 people
- Sponsor
- Janssen Research & Development, LLC
Aortic Valve Stenosis
FORWARD PRO Study Interventional Post-market Study With the Evolut™ PRO System
Prospective, single-arm, multi-center, interventional post-market study. After signing informed consent, eligible subjects will be implanted with the CE marked Evolut™ PRO system.
- Trial name
- NCT03417011
- Testing
- Medtronic CoreValve™ Evolut™ PRO System (Evolut™ PRO System)
- Where
- 39 sites in Austria, Belgium and 12 more
- Volunteers
- 638 people
- Sponsor
- Medtronic Cardiovascular
Aortic Valve Stenosis
Impact of Postdilatation With the InterValve V8 Aortic Valvuloplasty Balloon Following TAVI Procedure
This study is designed to monitor the safety and performance of the V8 balloon when used as a postdilatation balloon in self-expanding Transcatheter Aortic Valve Implantation (TAVI) device procedures.
- Trial name
- PostCorE (NCT02472106)
- Testing
- Post-dilatation
- Volunteers
- 9 people
- Sponsor
- InterValve, Inc.
Homozygous Familial Hypercholesterolemia
Effects of Lomitapide on Carotid and Aortic Atherosclerosis
Study to assess changes in carotid and aortic atherosclerosis in patients being treated with lomitapide.
- Trial name
- NCT02399852
- Testing
- Lomitapide
- Sponsor
- Aegerion Pharmaceuticals, Inc.
Thoracoabdominal Aortic Aneurysm, Endovascular Repair of Aortic Aneurysm
ANATOMICAL FEASIBILITY OF BRAILE STANDARD BRANCHED ENDOGRAFT
The objective of this retrospective observational study is to evaluate the theoretical anatomical suitability of the new Braile off-the-shelf multi-branched endograft in patients with thoracoabdominal aneurysm.
- Conditions
- Thoracoabdominal Aortic Aneurysm, Endovascular Repair of Aortic Aneurysm, Vascular Diseases, Aortic Diseases
- Trial name
- BMETA (NCT07118995)
- Testing
- Analysis of preoperative CTA
- Where
- Brazil
- Volunteers
- 100 people
- Sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda.
Aortic Aneurysm, Abdominal
Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms
The purpose of the study is to assess the safety and effectiveness of the GORE® EXCLUDER® Conformable AAA Endoprosthesis to treat an infrarenal aneurysm located in the abdominal aorta.
- Trial name
- NCT02489539
- Testing
- GORE® EXCLUDER® Conformable AAA Endoprosthesis
- Where
- 51 sites in United States
- Volunteers
- 175 people
- Sponsor
- W.L.Gore & Associates
Aortic Valve Stenosis, Aortic Valve Calcification
ACURATE Enhance Post Market Study
The objective of the ACURATE Enhance study is to assess valve frame expansion and hemodynamics in a routine clinical setting when optimized procedural steps for valve implantation are followed.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Calcification, Aortic Diseases
- Trial name
- NCT06959862
- Testing
- Transcatheter Aortic Valve Implantation/Replacement
- Sponsor
- Boston Scientific Corporation
Aortic Valve Stenosis, Aortic Valve Failure
Portico Valve-in-Valve Retrospective Registry
The objective of this data-collection study is to retrospectively evaluate the safety and clinical performance of the Portico transthoracic aortic valve for Valve-in-Valve treatment of a failed aortic surgical bioprosthetic valve…
- Conditions
- Aortic Valve Stenosis, Aortic Valve Failure, Aortic Insufficiency, Aortic Stenosis
- Trial name
- NCT05002088
- Testing
- Transcatheter Aortic Valve Replacement
- Where
- 7 sites in Australia, Denmark and 2 more
- Volunteers
- 71 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Stenosis
A Registry to Evaluate the Direct Flow Medical Transcatheter Aortic Valve System
The purpose of this postmarket Registry is to assess the standard of care and clinical outcomes of the Direct Flow Medical Transcatheter Aortic Valve System used in clinical routine according to the approved commercial…
- Trial name
- DISCOVER (NCT01845285)
- Testing
- Aortic Valve Replacement
- Where
- 2 sites in Germany, Italy
- Volunteers
- 1,000 people
- Sponsor
- Direct Flow Medical, Inc.