Clinical trials: Aortic Diseases
Iliac Aneurysm, Aortic Aneurysm
Cook Iliac Branch Graft Post-market Registry
The Cook Iliac Branch Graft Post-market Registry will obtain case reports of physician experience with a CE-marked Cook Iliac Branch Graft to further confirm device safety and performance.
- Trial name
- NCT01055275
- Testing
- Implantation with a Cook Iliac Branch Graft
- Where
- Spain
- Volunteers
- 2 people
- Sponsor
- Cook Group Incorporated
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
Abdominal Aortic Aneurysm
Zenith® AAA Endovascular Graft Clinical Study
The purpose of this study is to evaluate the safety and effectiveness of the Cook Zenith Endovascular Graft for the treatment of abdominal aortic (AAA), aortoiliac, and iliac aneurysms.
- Trial name
- NCT00196092
- Testing
- Roll-in, Surgical, Standard Risk
- Volunteers
- 819 people
- Sponsor
- Cook Group Incorporated
Heart Valve Diseases, Aortic Valve Stenosis
BIOVALVE - I / II Clincial Investigation
First-in-Human clinical investigation to evaluate the safety and clinical performance of the BIOVALVE prosthesis in subjects presenting with severe symptomatic aortic valve stenosis, which are as judged by the heart team…
- Trial name
- BIOVALVE (NCT02249000)
- Testing
- BIOVALVE prosthesis
- Where
- 13 sites in Belgium, Germany and 2 more
- Volunteers
- 68 people
- Sponsor
- Biotronik AG
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
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 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
PILot Aortic Triflo Valve Study
A prospective, single arm, exploratory clinical investigation to assess preliminary safety and collect performance and effectiveness data of the TRIFLO Heart Valve.
- Trial name
- PILATUS (NCT06119607)
- Testing
- TRIFLO Heart Valve
- Where
- Lithuania
- Volunteers
- 10 people
- Sponsor
- Novostia SA
Congenital Heart Defect
Post-market Clinical Follow-up Study With Magnetic Resonance Imaging Conditional Guide Wire
This is post-market clinical follow-up study on 25 consecutive patients in two centers to evaluate the safety and performance of magnetic resonance imaging conditional guide wire and the acceptability of identified risks in the…
- Trial name
- MRWIREPMCF (NCT02493634)
- Testing
- pressure gradient measurement, MRWire
- Where
- 3 sites in Germany, United Kingdom
- Volunteers
- 25 people
- Sponsor
- Nano4Imaging GmbH
Aortic Aneurysm, Abdominal Aortic Aneurysm
Zenith® p-Branch™: Single-Center Study
The Zenith® p-Branch™: Single-Center Study is a clinical trial approved by Swedish Regulatory Authority to study the safety and effectiveness of the Zenith® p-Branch™ in the treatment of abdominal aortic aneurysms.
- Trial name
- PBCT (NCT01663064)
- Testing
- Endovascular treatment (Zenith® p-Branch™ endovascular graft)
- Where
- Sweden
- Volunteers
- 23 people
- Sponsor
- Cook Group Incorporated
Abdominal Aortic Aneurysms
Talent Converter Post-Approval Study
The primary endpoint is successful secondary endovascular treatment with the Talent Converter stent graft of subjects having received prior endovascular repair of infrarenal abdominal aortic or aortoiliac aneurysms using the…
- Trial name
- NCT01129609
- Testing
- Talent Converter Stent Graft and Talent Occluder with Occluder Delivery System
- Volunteers
- 20 people
- Sponsor
- Medtronic Cardiovascular
Acute Coronary Syndrome
Ticagrelor Removal Study Using CytoSorb® 300 mL Device During CPB in Patients Undergoing Emergent Cardiothoracic Surgery
The aim of CyTation is to demonstrate intra-operative removal of ticagrelor by CytoSorb® hemadsorption in patients on ticagrelor undergoing emergent cardiothoracic surgery requiring CPB, using platelet reactivity to adenosine…
- Trial name
- CyTation (NCT04625764)
- Testing
- Blood sampling and analysis
- Where
- 4 sites in Germany, Luxembourg
- Volunteers
- 6 people
- Sponsor
- CytoSorbents Europe GmbH
Aortic Aneurysm Abdominal
Zenith® p-Branch® Endovascular Graft Pivotal Study
The Zenith® p-Branch® Pivotal Study is a clinical trial approved by FDA to study the safety and effectiveness of the Zenith® p-Branch® endovascular graft in combination with the Atrium iCAST™ covered stents in the treatment of…
- Trial name
- NCT02396199
- Testing
- Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents
- Where
- 27 sites in United States
- Volunteers
- 80 people
- Sponsor
- Cook Research Incorporated
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.
Abdominal Aortic Aneurysm
TriVascular Evaluation of Females Who Are Underrepresented Candidates for Abdominal Aortic Aneurysm Repair in Europe
The LUCY Study is a prospective, consecutively enrolling, non-randomized multi center post-market study to evaluate the low profile (14F) Ovation® Abdominal Stent Graft Platform when used in the endovascular treatment of female…
- Trial name
- LUCY (NCT02703428)
- Where
- 10 sites in Belgium, Germany and 2 more
- Volunteers
- 30 people
- Sponsor
- TriVascular, Inc.
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
Aortic Valve Stenosis, Aortic Valve Calcification
REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve SystEm
This is a prospective, single-arm feasibility study designed to assess the acute safety and performance of the Lotus Valve System for transcatheter aortic valve replacement in symptomatic patients with calcified aortic valve…
- Conditions
- Aortic Valve Stenosis, Aortic Valve Calcification, Aortic Valve Disease
- Trial name
- REPRISE I (NCT01383720)
- Testing
- Lotus Valve System
- Where
- 3 sites in Australia
- Volunteers
- 11 people
- Sponsor
- Boston Scientific Corporation