Clinical trials: Aortic Diseases
- Condition Aortic Diseases
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
Heart Valve Disease
Aortic Replacement Using Individualised Regenerative Allografts - ARISE (the "Surveillance")
Evaluation of decellularized human heart valves for aortic heart valve replacement in comparison to current valve substitutes. Safety endpoints include cardiovascular adverse events, time to re-operation, re-intervention and…
- Trial name
- ARISE (NCT02527629)
- Testing
- Decellularized human heart valves
- Where
- 8 sites in Belgium, Germany and 5 more
- Volunteers
- 144 people
- Sponsor
- corlife
Coarctation of the Aorta
Large Diameter Advanta™ V12 Covered Stent Trial for Coarctation of the Aorta
This study is designed as a prospective, multicenter, non-randomized, single arm study to assess the safety and effectiveness of the Large Diameter Advanta™ V12 Covered Stent for stent implantation in coarctations of the aorta.
- Trial name
- NCT00978952
- Testing
- Large Diameter Advanta™ V12 Covered Stent
- Where
- 9 sites in Australia, Brazil and 5 more
- Volunteers
- 70 people
- Sponsor
- Atrium Medical Corporation
Heart Diseases, ASD - Atrial Septal Defect
Abbott Structural Heart Device Registry
The Abbott Structural Heart (SH) Registry is being conducted to confirm the safety and performance of Abbott's SH devices in a post-market, real-world setting.
- Conditions
- Heart Diseases, ASD - Atrial Septal Defect, VSD - Muscular Ventricular Septal Defect, PFO - Patent Foramen Ovale
- Trial name
- SH-Registry (NCT06590467)
- Testing
- Amplatzer™ Occlusion Devices, Epic™ Surgical Tissue Heart Valve devices
- Where
- 36 sites in United States, Denmark and 8 more
- Volunteers
- 2,500 people
- Sponsor
- Abbott Medical Devices
Aortic Stenosis
PARTNER II Trial: S3iCAP
Following completion of enrollment in the PARTNER II SAPIEN 3 intermediate risk trial, this trial provided continued access to treatment for subjects with severe aortic stenosis who were at intermediate surgical risk.
- Trial name
- PII S3i CAP (NCT02687035)
- Testing
- SAPIEN S3 valve
- Where
- 56 sites in United States, Canada
- Volunteers
- 1,822 people
- Sponsor
- Edwards Lifesciences
Stroke
PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter Aortic Valve Replacement
To demonstrate that use of the Sentinel® Cerebral Protection System significantly reduces the risk of peri-procedural stroke (≤72 hours) after transcatheter aortic valve replacement (TAVR).
- Trial name
- PROTECTED TAVR (NCT04149535)
- Testing
- Sentinel® Cerebral Protection System
- Where
- 57 sites in United States, Australia and 4 more
- Volunteers
- 3,000 people
- Sponsor
- Boston Scientific Corporation
Aortic Valve Disease
SJM Masters HP 15mm Rotatable Mechanical Heart Valve as Aortic Valve Replacement Therapy
This PAS is an observational, non-randomized, multi-center, single arm, clinical study to evaluate long term safety and effectiveness of the SJM™ Masters Series Hemodynamic Plus (HP) 15mm aortic mechanical heart valve (15…
- Trial name
- NCT03924661
- Testing
- Aortic Valve Replacement
- Where
- 13 sites in United States, Germany
- Volunteers
- 20 people
- Sponsor
- Abbott Medical Devices
Severe Aortic Stenosis
Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement
The purpose of the study is to evaluate the safety and efficacy of the Medtronic CoreValve® System in the treatment of symptomatic severe aortic stenosis in subjects who have a predicted high risk for aortic valve surgery and/or…
- Trial name
- NCT01240902
- Testing
- Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI), Surgical Aortic Valve Replacement (SAVR)
- Where
- 45 sites in United States
- Volunteers
- 1,453 people
- Sponsor
- Medtronic Cardiovascular
Thoracic Aortic Aneurysm, Penetrating Aortic Ulcer
Zenith Thoracic Alpha (ZTA) Post-Market Data Collection
This study aims to gather real-world clinical data demonstrating the continued safety and performance of the a marketed stent graft (Zenith® Alpha Thoracic Endovascular Graft [ZTA]) and collect longer term follow-up to better…
- Trial name
- NCT06094127
- Testing
- Endovascular aortic treatment
- Where
- 10 sites in France, Germany and 2 more
- Volunteers
- 300 people
- Sponsor
- Cook Research Incorporated
Aortic Aneurysm, Thoracoabdominal
Post-market Observational Study Zenith® t-Branch™
The Zenith® t-Branch™ Thoracoabdominal Endovascular Graft Study is a post-market observational study to evaluate the performance of the Zenith® t-Branch™ in the treatment of thoracoabdominal aortic aneurysms in routine care.
- Trial name
- NCT02104089
- Testing
- Zenith® t-Branch™ Thoracoabdominal Endovascular Graft
- Where
- 3 sites in Germany, Sweden
- Volunteers
- 80 people
- Sponsor
- Cook Group Incorporated
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 Stenosis
Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement
The objective of this study is to evaluate the safety and effectiveness of the Lotus™ Valve System and LOTUS Edge™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe…
- Trial name
- REPRISE III (NCT02202434)
- Testing
- Lotus Valve System, CoreValve/Evolut R Transcatheter Aortic Valve Replacement System, LOTUS Edge Valve System
- Where
- 58 sites in United States, Australia and 4 more
- Volunteers
- 1,425 people
- Sponsor
- Boston Scientific Corporation
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.
Colon Ischemia, Aortic Aneurysm
Prevention of Colon Ischemia During Aortic Aneurysm (AAA) Repair
Patients undergoing surgery on their Aorta can get ischemia, a lack of blood flow, to their intestines and colon. This is very serious, as 2 out of 3 patients who have this problem die before leaving the hospital.
- Trial name
- NCT00671203
- Testing
- Reestablish colon blood flow
- Where
- 2 sites in United States
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Spectros Corporation
Aortic Stenosis, Aortic Insufficiency
JUPITER Study: Transapical Aortic Valve Implantation for Aortic Regurgitation
The purpose of this registry is to observe longterm performance and safety of the JenaValve TAVI system, in routine medical and everyday conditions.
- Conditions
- Aortic Stenosis, Aortic Insufficiency, Aortic Regurgitation
- Trial name
- JUPITER (NCT01598844)
- Testing
- Transcatheter aortic valve replacement
- Where
- 15 sites in Germany, Netherlands and 2 more
- Volunteers
- 210 people
- Sponsor
- JenaValve Technology, Inc.
Aortic Valve Stenosis
Clinical Evaluation of MDT-2111 in Subjects With Small Aortic Annuli and Symptomatic Severe Aortic Stenosis
The primary objective of the present trial is to demonstrate the safety and effectiveness of the MDT-2111 in the treatment of symptomatic severe aortic stenosis in subjects with small aortic annuli and deemed difficult for…
- Trial name
- NCT01634269
- Testing
- MDT-2111 TAVI 23 mm
- Where
- 4 sites in Japan
- Volunteers
- 20 people
- Sponsor
- Medtronic Cardiovascular
Aortic Valve Stenosis
CENTERA PMCF: Post-Market Follow-up of the CENTERA Transcatheter Heart Valve System
This study will monitor device performance and safety of the Edwards CENTERA Transcatheter Heart Valve (THV) system in patients with severe, symptomatic aortic valve stenosis who are indicated for aortic valve replacement.
- Trial name
- NCT03699345
- Testing
- Transcatheter Aortic Valve Replacement (TAVR)
- Where
- 11 sites in Denmark, France and 4 more
- Volunteers
- 87 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis
HLT Meridian Valve CE Mark Trial
To evaluate the safety and performance of the HLT System in patients with symptomatic heart disease due to severe aortic stenosis who are judged by the Heart Team to be at Intermediate or High Risk for aortic valve replacement…
- Trial name
- RADIANT CE (NCT03805711)
- Testing
- HLT® Transcatheter System
- Where
- Canada
- Volunteers
- 1 people
- Sponsor
- HLT Inc.
Aortic Arch Aneurysm
The NEXUS™ Compassionate Use Data Collection Study
A Multicenter, observational Data Collection Study to Evaluate the Safety and Performance of the Nexus™ Aortic Arch Stent Graft System in patients that were implanted with the device as part of Compassionate Use Procedures.
- Trial name
- NCT03420066
- Testing
- Retrospective data collection
- Where
- 4 sites in Italy, New Zealand and 1 more
- Volunteers
- 7 people
- Sponsor
- Endospan Ltd.
Aortic Stenosis
CHANGE Neo™ TA Registry With ACURATE Neo™ Aortic Bioprosthesis and ACURATE Neo™ TA Transapical Delivery System
The purpose of this registry is to collect specific health and patient data to identify more precisely the patient population undergoing TA aortic valve replacement with the ACURATE neo™ Aortic biprosthesis and ACURATE neo™ TA…
- Trial name
- NCT03454360
- Testing
- ACURATE neo™ Aortic Bioprosthesis
- Where
- 10 sites in Germany
- Volunteers
- 107 people
- Sponsor
- Symetis SA
Aortic Valve Stenosis
REPRISE EDGE 29 mm EU Study
The objective of the REPRISE EDGE 29 mm EU study is to evaluate performance and safety of the 29 mm LOTUS Edge™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe native…
- Trial name
- NCT02964962
- Testing
- 29 mm LOTUS Edge™ Valve System
- Sponsor
- Boston Scientific Corporation