Clinical trials: Aorta Disease
Aortic Valve Stenosis, Valvular Heart Disease
CoreValve Advance-II Study: Prospective International Post-market Study
The CoreValve ADVANCE-II Study is a best practices investigation of patients implanted with the Medtronic CoreValve bioprosthesis.
- Trial name
- Advance-II (NCT01624870)
- Where
- 9 sites in Belgium, Czechia and 4 more
- Volunteers
- 200 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Hypertension, Dyslipidemia
Duowell® vs. Telmisartan Monotherapy in Mild Dyslipidemia Patients With Hypertension
This study is to evaluate effect and safety on central blood pressure with Duowell compared to telmisartan monotherapy in mild dyslipidemia patients with hypertension during 16 weeks.
- Trial name
- NCT03267329
- Testing
- Duowell®, Telmisartan
- Where
- South Korea
- Volunteers
- 80 people
- Sponsor
- Yuhan Corporation
Aortic Valve Disease
PAR I - Patient-to-Annulus Relation I
The Prosthesis-to-Annulus Relation I (PAR I) trial is a German multicenter study assessing the relation between the prosthetic GOA and the area of LVOT as potentially new parameter for the prediction of hemodynamic outcome.
- Trial name
- PARI (NCT02981004)
- Where
- 7 sites in Germany
- Volunteers
- 304 people
- Sponsor
- Abbott Medical Devices
Abdominal Aortic Aneurysm
Global Fenestrated Anaconda Clinical STudy
This study is a prospective non-interventional, multi-centre study of the Vascutek Fenestrated Anaconda™ system, and is essentially a post-market study.
- Trial name
- Global FACT (NCT03180996)
- Testing
- Vascutek Fenestrated Anaconda™ Custom AAA Stent Graft System
- Where
- 11 sites in Australia, Austria and 3 more
- Volunteers
- 160 people
- Sponsor
- Vascutek Ltd.
Abdominal Aortic Aneurysms, Iliac Aneurysms
Zenith(R) Low Profile AAA Endovascular Graft Clinical Study
The Zenith® Low Profile AAA Endovascular Graft Clinical Study is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® Low Profile AAA Endovascular Graft to treat abdominal aortic, aorto-iliac…
- Conditions
- Abdominal Aortic Aneurysms, Iliac Aneurysms, Aorto-iliac Aneurysms
- Trial name
- NCT00833924
- Testing
- Zenith(R) Low Profile AAA Endovascular Graft
- Where
- 27 sites in United States, China and 3 more
- Volunteers
- 120 people
- Sponsor
- Cook Group Incorporated
Aortic Valve Stenosis, Aortic Valve Insufficiency
Enable® Aortic Sutureless Bioprosthesis Evaluation
The EASE Enable study is intended to collect additional data on the clinical outcomes of the Medtronic Enable® Aortic Bioprosthesis in "real world" patients.
- Trial name
- EASE (NCT01720342)
- Testing
- Aortic Valve Replacement surgery
- Where
- 17 sites in France, Germany and 5 more
- Volunteers
- 225 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Aneurysm of Aorta, Thoracic, Dissection of Aorta, Thoracic
TBE Zone 0/1 PMS in Japan
The goal of this surveillance is to confirm the safety and efficacy of TBE under actual use in the Zone 0/1 lesion on post-marketing usage conditions.
- Conditions
- Aneurysm of Aorta, Thoracic, Dissection of Aorta, Thoracic, Trauma
- Trial name
- NCT07691931
- Testing
- Gore® TAG® Thoracic Aortic Branch Stent Graft System
- Volunteers
- 75 people
- Sponsor
- W.L.Gore & Associates
Aortic Stenosis
ECG-based AI Screening for Cases of Undiagnosed Moderate-to-Severe Aortic Stenosis in the Primary Care Setting
The goal of this observational study is to learn whether AccurKardia's AK-AVS algorithm can help identify moderate-to-severe aortic stenosis (AS), a narrowing of the heart's aortic valve, in older adults who have not yet been…
- Trial name
- NCT07827105
- Testing
- AK-AVS
- Where
- United States
- Volunteers
- 4,000 people, healthy volunteers welcome
- Sponsor
- AccurKardia, Inc.
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.
Aortic Arch Aneurysm
Guo's Aortic Arch Reconstruction :The Prospective ,Multiple Center Study About the Safety and Efficacy of WeFlow-Arch Modeler Embedded Branch Stent Graft System (GIANT Study)
A prospective ,Multiple Center Study About the Safety and Efficacy of WeFlow-Arch Modeler Embedded Branch Stent Graft System manufactured by EndoNom Medtech (Hangzhou) Co., Ltd.
- Trial name
- NCT04765592
- Testing
- WeFlow-Arch Modeler Embedded Branch Stent Graft System
- Where
- 23 sites in China
- Volunteers
- 88 people
- Sponsor
- Hangzhou Endonom Medtech Co., Ltd.
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
Breastfeeding, Hypertrophic Cardiomyopathy
Mavacamten Pregnancy Surveillance Program
The purpose of this observational pregnancy safety study is to assess maternal, fetal, and infant outcomes after exposure to mavacamten at any time during pregnancy and/or breastfeeding.
- Conditions
- Breastfeeding, Hypertrophic Cardiomyopathy, Pregnancy Related
- Trial name
- NCT05939700
- Testing
- Mavacamten
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Bristol-Myers Squibb
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.
Abdominal Aortic Aneurysms (AAA)
The Vascutek Custom Fenestrated Anaconda Post-Market Surveillance Study
This is a multicentre, prospective, observational post-market registry (follow-up 1 month, 1 year, 2 years, 3 years, 4 years and 5 years) to monitor the post-market clinical safety and effectiveness of the Vascutek AnacondaTM…
- Trial name
- NCT01826344
- Where
- 71 sites in Austria, Belgium and 10 more
- Volunteers
- 628 people
- Sponsor
- Vascutek Ltd.
TAAA, AAA - Abdominal Aortic Aneurysm
Data Collection of the TUVA BX and iCover Stent Grafts Implanted During Branched Endovascular Aortic Repair (BEVAR)
The study aims to check whether the TUVA BX and iCover stent grafts are safe and work well when used during a specific type of minimally invasive surgery (BEVAR) to treat complex aortic aneurysms.
- Trial name
- NCT07540507
- Testing
- Endovascular Aortic Repair
- Where
- Netherlands
- Volunteers
- 105 people
- Sponsor
- JOTEC GmbH
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.
Aortic Stenosis
Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement (REPRISE Japan)
The objective of this study is to confirm the safety and effectiveness of the Lotus™ Valve System in the Japanese medical environment for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe…
- Trial name
- NCT02491255
- Testing
- Lotus Valve System
- Where
- 5 sites in Japan
- Volunteers
- 70 people
- Sponsor
- Boston Scientific Corporation
Aortic Insufficiency
HAART 200 Aortic Valve Annuloplasty Trial
The HAART 200 "Aortic Annuloplasty during Bicuspid Aortic Valve Reconstruction" Trial is a prospective, non-randomized, multi-center trial to evaluate the safety and effectiveness of the HAART 200 bicuspid annuloplasty ring when…
- Trial name
- NCT02071849
- Testing
- HAART 200 Aortic Valve Annuloplasty Device
- Where
- 4 sites in Germany
- Volunteers
- 20 people
- Sponsor
- Biostable Science & Engineering
Transcatheter Aortic Valve Replacement (TAVR), Cerebral Vascular Accident (CVA)/Stroke
Evaluation of the Safety and Effectiveness of CHORDS® Cerebral Protection System During TAVR: DUET Trial
This is a prospective, multi-center, randomized controlled study. The goal of the study is to assess the safety and effectiveness of the Resonova® CHORDS® Cerebral Protection System in capturing and removing embolic debris during…
- Trial name
- NCT07648693
- Testing
- CHORDS® Cerebral Protection System, Sentinel Cerebral Protection System
- Where
- 15 sites in China
- Volunteers
- 240 people
- Sponsor
- Resonova (Shanghai) Medtech Limited
Aortic Stenosis Senile, Aortic Stenosis Symptomatic
Safety and Clinical Performance of the Next-Generation SAFESYNC Transcatheter Heart Valve in Patients With Severe Aortic Stenosis
The objective of this pivotal, prospective, multicenter, single-arm clinical trial is to evaluate the safety and clinical performance of the Next-Generation INOVARE® SAFESYNC Bioprosthetic Heart Valve, implanted via a…
- Conditions
- Aortic Stenosis Senile, Aortic Stenosis Symptomatic, Aortic Stenosis
- Trial name
- SAFESYNC NG (NCT07806409)
- Testing
- INOVARE® SAFESYNC Next-Generation Bioprosthetic Heart Valve
- Volunteers
- 40 people
- Sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda.