Clinical trials: Aorta Disease
Aortic Stenosis
A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis
The purpose of this study is to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) administered subcutaneously once monthly compared to placebo in slowing the progression of calcific aortic valve stenosis.
- Trial name
- NCT05646381
- Testing
- Pelacarsen (TQJ230) 80mg
- Where
- 140 sites in United States, Austria and 13 more
- Volunteers
- 502 people
- Sponsor
- Novartis Pharmaceuticals
Aortic Valve Stenosis
The Medtronic TAVR 2.0 US Clinical Study
The study objective is to evaluate safety and efficacy of the Medtronic TAVR (Transcatheter Aortic Valve Replacement) 2.0 system in patients with severe symptomatic aortic stenosis who are considered at high through extreme risk…
- Trial name
- NCT02738853
- Testing
- Medtronic Transcatheter Aortic Valve 2.0 Replacement System
- Where
- 8 sites in United States
- Volunteers
- 93 people
- Sponsor
- Medtronic Cardiovascular
Complex Congenital Heart Defect, Dysfunctional RVOT Conduit
COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
This study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems in subjects with a dysfunctional right ventricular outflow tract (RVOT)…
- Conditions
- Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration
- Trial name
- NCT02744677
- Testing
- SAPIEN 3/SAPIEN 3 Ultra RESILIA THV, SAPIEN 3 THV, SAPIEN 3 Ultra RESILIA THV
- Where
- 27 sites in United States
- Volunteers
- 108 people
- Sponsor
- Edwards Lifesciences
Vascular Aneurysm
French Registry Conducted on E-vita OPEN NEO
Observational, prospective/retrospective, non-randomised, non-comparative, multicentre cohort study. Primary objective is evaluation of in-hospital all-cause mortality after treatment of extensive acute and chronic aortic…
- Trial name
- NEO (NCT05721001)
- Testing
- Surgical Repair
- Where
- 23 sites in France
- Volunteers
- 130 people
- Sponsor
- JOTEC GmbH
Aortic Stenosis
Multicenter Study for the Validation of Willem AI: Aortic StenoSis Early Diagnosis With AI-electrocardiogram Study
AoS-SEDAI study is an observational, multicenter, retrospective and prospective clinical study. This study aims to assess Willem Artificial Intelligence (AI) ability to distinguish between aortic stenosis (AS) and non-AS patients…
- Trial name
- AoS-SEDAI (NCT07479992)
- Testing
- Willem AI ECG assessment
- Where
- 2 sites in Germany
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Idoven 1903 S.L.
Thoracic Diseases, Aortic Aneurysm
Thoraflex Hybrid and Relay Extension Post-Approval Study
The goal of this observational study is to evaluate the Thoraflex Hybrid device alone and in combination with the RelayPro NBS stent-graft in the treatment of aortic disease affecting the aortic arch and descending aorta with or…
- Conditions
- Thoracic Diseases, Aortic Aneurysm, Aortic Dissection, Thoracic Aortic Aneurysm
- Trial name
- EXTEND (NCT05639400)
- Testing
- Thoraflex Hybrid, RelayPro NBS
- Where
- 27 sites in United States, Austria and 5 more
- Volunteers
- 352 people
- Sponsor
- Vascutek Ltd.
Abdominal Aortic Aneurysm (AAA)
Clinical Study of the Treovance Stent-Graft for Patients With Abdominal Aortic Aneurysms
The purpose of this clinical trial is to assess and evaluate the safety and efficacy of the Treovance Stent-Graft with Navitel Delivery System in subjects with Abdominal Aortic Aneurysms (AAA).
- Trial name
- NCT02009644
- Testing
- Subjects who receive the Treovance stent-graft
- Where
- 29 sites in United States
- Volunteers
- 158 people
- Sponsor
- Bolton Medical
Aortic Valve Stenosis, Mitral Regurgitation
Addressing Under-treatment and Health Equity in AS and MR Using an Integrated EHR Platform
This multi-center, prospective, cluster-randomized controlled trial will evaluate Tempus Next automated notifications as an intervention to support identification and evaluation of patients possibly indicated for Valve…
- Trial name
- ALERT (NCT06099665)
- Testing
- Automated alert
- Where
- 6 sites in United States
- Volunteers
- 2,118 people
- Sponsor
- Tempus AI
Heart Valve Diseases
ATS 3f(r) Aortic Bioprosthesis Model 1000, 19mm
The initial clinical investigation titled "ATS 3f(r) Aortic Bioprosthesis Model 1000 Study," was a prospective, non-randomized, multi-center study designed to evaluate the the safety and effectiveness obtained from 800 patient…
- Trial name
- NCT00657826
- Testing
- ATS 3f® Aortic Bioprosthesis, Model 1000, 19mm
- Where
- 2 sites in United States, Canada
- Volunteers
- 22 people
- Sponsor
- Medtronic Cardiovascular
Diseases of Aortic Valve, Aortic Regurgitation Disease
Clinical Trial in China
The purpose of this clinical study is to evaluate the effectiveness and safety of the transcatheter aortic valve system in the treatment of patients with severe aortic regurgitation disease who are at high or prohibitive surgical…
- Trial name
- NCT05580952
- Testing
- Transcatheter aortic valve replacement
- Where
- 15 sites in China
- Volunteers
- 120 people
- Sponsor
- Genesis Medtech Corporation
Cardiac Surgery, Coronary Artery Bypass
An Trial of Two Dosing Regimens of AP214 for the Prevention of Kidney Injury in Patients Undergoing Cardiac Surgery
This study investigates the effect of two dose-levels of AP214 on the prevention of (acute) kidney injury after cardiac surgery.
- Conditions
- Cardiac Surgery, Coronary Artery Bypass, Aortic Aneurysm, Valve Surgery
- Trial name
- NCT01256372
- Testing
- AP214
- Where
- Denmark
- Volunteers
- 77 people
- Sponsor
- Action Pharma A/S
Aortic Stenosis, Symptomatic Aortic Stenosis
China XT: Safety and Effectiveness of Edwards Lifesciences SAPIEN XT THV in the Chinese Population
To evaluate the safety and effectiveness of the SAPIEN XT (Edwards Lifesciences, Irvine, California) transcatheter heart valve implantation (TAVI) in Chinese patients with symptomatic severe calcific aortic stenosis who are…
- Conditions
- Aortic Stenosis, Symptomatic Aortic Stenosis, Aortic Regurgitation
- Trial name
- NCT03314857
- Testing
- SAPIEN XT THV with the NovaFlex+ delivery system
- Where
- 3 sites in China
- Volunteers
- 67 people
- Sponsor
- Edwards Lifesciences
Aortic Aneurysm, Abdominal
Aorfix Intelliflex First in Human Study
The First In Human (FIH) study is a long-term, single center, non-randomized study established by Lombard Medical, Inc. to collect "on-label" data in the clinical setting on patients undergoing endovascular repair with…
- Trial name
- FIH-NZ (NCT02907762)
- Testing
- Endovascular aneurysm repair EVAR
- Volunteers
- 10 people
- Sponsor
- Lombard Medical
Obstructive Hypertrophic Cardiomyopathy (oHCM)
Evaluation of Mavacamten-Based Practice in Chinese Adults With Obstructive Hypertrophic Cardiomyopathy
The study will describe how mavacamten is used in routine care for Chinese adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM), including use as monotherapy or with other background/concomitant oHCM medications.
- Trial name
- REMAP-HCM (NCT07846059)
- Testing
- Mavacamten
- Where
- China
- Volunteers
- 800 people
- Sponsor
- Bristol-Myers Squibb
Thoracic Aortic Aneurysms
Safety and Efficacy of Valiant Mona LSA Stent Graft System
The Valiant Mona LSA thoracic stent graft system is for the endovascular repair of aneurysms of the descending thoracic aorta (DTA) in patients who require coverage of the left subclavian artery (LSA).The study is intended to…
- Trial name
- NCT01839695
- Testing
- Valiant Mona LSA Stent Graft System
- Where
- 3 sites in United States, United Kingdom
- Volunteers
- 9 people
- Sponsor
- Medtronic Cardiovascular
Cardiovascular Procedures, Thoracic Aortic Aneurysm
Post Market Surveillance Study Evaluating BioFoam Surgical Matrix in Cardiovascular Surgery
This is a prospective, multicenter, single-arm study designed to collect clinical data to support the safety and effectiveness of BioFoam used as a surgical adjunct to anastomotic hemostasis following cardiovascular surgery.
- Conditions
- Cardiovascular Procedures, Thoracic Aortic Aneurysm, Aortic Valve Replacement, Type A Aortic Dissection
- Trial name
- NCT02164201
- Where
- 2 sites in Germany, Italy
- Volunteers
- 75 people
- Sponsor
- CryoLife Europa
Abdominal Aortic Aneurysm
TriVascular European Union (EU) Abdominal Stent Graft Trial
A Clinical Study to Evaluate the Safety and Performance of the TriVascular Ovation Abdominal Stent Graft System
- Trial name
- NCT01097772
- Testing
- Implant of Ovation Abdominal Stent Graft System
- Where
- 7 sites in Germany
- Volunteers
- 30 people
- Sponsor
- TriVascular, Inc.
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
Hypertrophic Obstructive Cardiomyopathy
First-in-Man Early Feasibility Study for Transcatheter HOCM Septal Ablation
Transcatheter Intra-septal RF ablation system (TIRA catheter with its supplemental devices) to treat hypertrophic obstructive cardiomyopathy.
- Trial name
- NCT04770142
- Testing
- TIRA catheter
- Where
- 9 sites in South Korea
- Volunteers
- 5 people
- Sponsor
- Tau-MEDICAL Co., Ltd.
Abdominal Aortic Aneurysm (AAA)
Comparative Study of a Software With the Gold Standard
Nurea wants to set-up a pivotal phase clinical study for its software PRAEVAorta, a decision-making support for diagnosis and follow-up of abdominal aorta aneurysm. This study is a comparative study.
- Trial name
- NCT04551183
- Testing
- Surgeons CT scan analysis, PRAEVAorta CT scan analysis
- Where
- France
- Sponsor
- Nurea