Clinical trials: Aorta Disease
Aortic Valve Disease, Aortic Valve Stenosis
Early Feasibility Study for the Foldax Tria Aortic Heart Valve
The purpose of this study is to conduct the initial clinical investigation of the Foldax Polymer Aortic Valve to collect evidence on the device's safety and performance.
- Trial name
- NCT03851068
- Testing
- Foldax Tria Aortic Valve
- Where
- 5 sites in United States
- Volunteers
- 40 people
- Sponsor
- Foldax, Inc
Aortic Valve Calcification, Aortic Valve Stenosis
VALVOSOFT® Pivotal Study
The objective of the study is to evaluate the safety and performance of a new non-invasive ultrasound therapy (NIUT) with Valvosoft in the treatment of Calified Aortic Stenosis
- Trial name
- NCT05235568
- Testing
- VALVOSFT intervention
- Where
- 11 sites in France, Germany and 1 more
- Volunteers
- 60 people
- Sponsor
- Cardiawave SA
Aorta, Thoracic Pathologies, Aortic Aneurysm, Thoracic
RE-GENERATION: The Safety and Performance of the Relay Pro and Relay NBS Pro Stent-graft Devices in the European Union (EU)
The objective of the study is to evaluate the safety and performance of Relay Pro and Relay NBS Pro devices in humans having thoracic aortic pathologies. Clinical results will be used to apply for the CE certification.
- Conditions
- Aorta, Thoracic Pathologies, Aortic Aneurysm, Thoracic, Aortic Aneurysm
- Trial name
- RE-GENERATION (NCT03207568)
- Testing
- Thoracic Endovascular Aortic Repair (TEVAR)
- Volunteers
- 30 people
- Sponsor
- Bolton Medical
Aortic Stenosis
ACURATE Prime XL Human Feasibility Study
To evaluate feasibility and safety of the ACURATE Prime™ XL Transfemoral Aortic Valve System for transcatheter aortic valve implantation (TAVI) in subjects with severe native aortic stenosis who are indicated for TAVI.
- Trial name
- NCT05224245
- Testing
- ACURATE Prime XL Transfemoral Aortic Valve System
- Where
- 3 sites in Australia
- Volunteers
- 13 people
- Sponsor
- Boston Scientific Corporation
Critical Aortic Stenosis
THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial
The purpose of this study is to determine the safety and effectiveness of the device and delivery systems (transfemoral and transapical) in high risk, symptomatic patients with severe aortic stenosis.
- Trial name
- PARTNER (NCT00530894)
- Testing
- Edwards SAPIEN Transcatheter Heart Valve, Surgical Valve Replacement, medical management and/or balloon aortic valvuloplasty
- Where
- 26 sites in United States, Canada and 1 more
- Volunteers
- 1,057 people
- Sponsor
- Edwards Lifesciences
Aortic Stenosis
ACURATE Neo™ Aortic Bioprosthesis for Implantation Using the ACURATE TA™ LP Transapical Delivery System in Patients With Severe Aortic Stenosis
Trial of ACURATE neo(TM) Aortic Bioprosthesis for Implantation using the ACURATE TA(TM) LP Transapical Delivery System in Patients with Severe Aortic Stenosis for evaluating the Safety and performance of the study device
- Trial name
- TALP-FIM (NCT02986737)
- Testing
- ACURATE neo™ and ACURATE TA™ LP
- Where
- 2 sites in Germany
- Volunteers
- 15 people
- Sponsor
- Symetis SA
Acute Aortic Dissection, Aortic Rupture
Thoraflex Hybrid Post-Market Study
This is a global, prospective non-interventional, multi-centre, post-market study of the Vascutek Thoraflex™ Hybrid system in patients with acute thoracic aortic syndrome, subacute/chronic dissection of the aorta and aortic…
- Conditions
- Acute Aortic Dissection, Aortic Rupture, Penetrating Aortic Ulcer, Aortic Dissection
- Trial name
- THOR (NCT03414866)
- Testing
- EQ-5D-5L QOL questionnaire
- Where
- 7 sites in Canada, Germany and 2 more
- Volunteers
- 182 people
- Sponsor
- Vascutek Ltd.
Thoracoabdominal Aortic Aneurysms
Thoracoabdominal Artery Stent Graft System Exploratory Study
This study is designed as a single-center, prospective, single-arm, open-label, exploratory study. The objective is to evaluate the feasibility of Thoracoabdominal Artery Stent Graft System for endovascular treatment of…
- Trial name
- NCT06710938
- Testing
- The system includes the G-Branch™ thoracoabdominal aortic stent graft system, the peripheral vascular stent graft system, and the aortic extension stent graft system
- Where
- Germany
- Volunteers
- 11 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
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
Atrial Fibrillation, Coronary Artery Disease
Clinical and Economic Consequences of Left Atrial Bipolar Radiofrequency Ablation of Persistent and Permanent Atrial Fibrillation During Cardiac Surgery
The clinical effects of intra-operative radiofrequency ablation in patients with persistent or permanent atrial fibrillation and an indication for an implantation of a heart valve prosthesis or coronary bypass surgery are the…
- Trial name
- NCT00157807
- Testing
- bipolar radiofrequency ablation of persistent and permanent AF
- Where
- 5 sites in Germany
- Volunteers
- 24 people
- Sponsor
- Medtronic Cardiac Surgery
Aortic Dissection, Distal Entry Tear
Guo&Amp;'s Distal Entry Tear Repair With WeFlow-EndoPatch System (Gallant Study)
A Multicenter, Randomized Controlled Study About the Safety and Efficacy of WeFlow-EndoPatch Aortic Endovascular Patch System manufactured by EndoNom Medtech (Hangzhou) Co., Ltd. for Chronic Aortic Dissection . (GALLANT Study)
- Trial name
- Gallant (NCT06945809)
- Testing
- WeFlow-EndoPatch Aortic Endovascular Patch System, Conventional Treatment group
- Where
- China
- Volunteers
- 216 people
- Sponsor
- Hangzhou Endonom Medtech Co., Ltd.
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 Valve Disease, Aortic Stenosis
EDWARDS INTUITY Valve System CADENCE Study
The study purpose is to compare the EDWARDS INTUITY valve system with commercially available stented aortic bioprostheses, in patients requiring aortic valve replacement surgery with coronary artery bypass.
- Trial name
- CADENCE (NCT02688153)
- Testing
- EDWARDS INTUITY, Stented aortic bioprostheses
- Where
- France
- Volunteers
- 120 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Disease, Mitral Valve Disease, Prosthetic Heart Valve Dysfunction, Valvular Heart Disease Requiring Surgical Aortic or Mitral Valve Replacement
Safety and Performance of Dafodil Heart Valves in Real-World Aortic and Mitral Valve Replacement
This study, called the EuroDafodil Registry, is being conducted to understand how safe and effective the Dafodil™ and Dafodil Neo™ Pericardial Bioprosthetic heart valves are when used in routine medical practice.
- Trial name
- NCT07379112
- Testing
- Dafodil™ / Dafodil Neo™ Pericardial Bioprosthetic Heart Valve
- Volunteers
- 500 people
- Sponsor
- Meril Life Sciences Pvt. Ltd.
Aortic Dissection, Aortic Aneurysm
A PMCF Study in Patients With Acute or Chronic Aortic Dissection or Aortic Aneurysm Treated With E-vita OPEN NEO
The NEOS post-market clinical follow-up study is undertaken to demonstrate the safety and clinical performance of E-vita OPEN NEO in the treatment of aneurysm or dissection in the ascending aorta, aortic arch and descending…
- Trial name
- NEOS (NCT04676672)
- Testing
- Open repair
- Where
- 2 sites in Austria, Germany
- Volunteers
- 163 people
- Sponsor
- JOTEC GmbH
Hypertrophic Cardiomyopathy
Multi-center, Open-label, Single-ascending Dose Study of Safety and Tolerability of TN-201 in Adults With Symptomatic MYBPC3 Mutation-associated HCM
This is a first-in-human, non-randomized, open-label study designed to evaluate the safety, tolerability, and pharmacodynamics (PD) of TN-201 in adult patients with symptomatic hypertrophic cardiomyopathy (HCM) caused by…
- Trial name
- MyPEAK-1 (NCT05836259)
- Testing
- TN-201
- Where
- 10 sites in United States
- Volunteers
- 30 people
- Sponsor
- Tenaya Therapeutics
Abdominal Aortic Aneurysm
Post-Approval Study of the TREO Abdominal Stent-Graft System
The purpose of this study is to determine the long-term performance of the TREO Abdominal Stent-Graft as a treatment for patients with Infrarenal Abdominal Aortic Aneurysms or Aorto-iliac Aneurysms.
- Trial name
- TREO PAS (NCT04697784)
- Testing
- TREO Abdominal Stent-Graft System
- Where
- 40 sites in United States
- Volunteers
- 338 people
- Sponsor
- Bolton Medical
Obstructive Hypertrophic Cardiomyopathy (oHCM)
Mavacamten in Obstructive Hypertrophic Cardiomyopathy
The purpose of this study is to evaluate the real-world outcomes of individuals diagnosed with obstructive hypertrophic cardiomyopathy (oHCM) treated with mavacamten at the Hospital of The University of Pennsylvania in the US
- Trial name
- NCT07168655
- Testing
- Mavacamten
- Where
- United States
- Volunteers
- 163 people
- Sponsor
- Bristol-Myers Squibb
Abdominal Aortic Aneurysms
Talent Aortic Cuff Stent Graft System Compassionate Use Registry
An evaluation of the TALENT Aortic Cuff in patients with existing AneuRx stent grafts who have experienced sub-optimal stent graft outcomes and are not deemed suitable candidates for treatment with an AneuRx Aortic Cuff.
- Trial name
- NCT00604643
- Testing
- TALENT Aortic Cuff Abdominal Stent Graft
- Where
- 50 sites in United States
- Sponsor
- Medtronic Cardiovascular
Aortic Valve Insufficiency
Evaluation of ARi With OpSens SavvyWire
The goal of this observational study is to establish the degree of agreement to Aortic Regurgitation (AR) severity during aortic valve intervention between the Aortic Regurgitation Index (ARi) measured by the Opsens SavvyWire…
- Trial name
- ARi (NCT06295068)
- Testing
- Transcatheter Aortic Valve Replacement (TAVR), Balloon Aortic Valvuloplasty (BAV)
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Opsens, Inc.