Clinical trials: Aortic Diseases
Aortic Valve Stenosis
PREVAIL-J - Transfemoral & Transapical Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Japan)
A single arm, prospective multicenter non-randomized pivotal clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX), NovaFlex™ transfemoral delivery system, Ascendra2™ transapical delivery…
- Trial name
- NCT01113983
- Testing
- Transcatheter aortic valve implantation
- Where
- 3 sites in Japan
- Volunteers
- 64 people
- Sponsor
- Edwards Lifesciences
Abdominal Aortic Aneurysm
Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks
To determine the safety and efficacy of IMPEDE-FX Embolization Plug and/or IMPEDE-FX Rapid Fill to fill an abdominal aortic aneurysm (AAA) sac outside of an endovascular aneurysm repair (EVAR) stent graft.
- Trial name
- AAA-SHAPE (NCT04227054)
- Testing
- IMPEDE-FX Embolization Plug
- Where
- 2 sites in New Zealand
- Volunteers
- 15 people
- Sponsor
- Shape Memory Medical, Inc.
Aortic Valve Stenosis, Heart Valve Diseases
JENAVALVE AS EFS TRIAL: Pericardial TAVR Aortic Stenosis Study
To collect information about treatment for severe aortic stenosis (AS), which affects the aortic valve in the heart. Aortic stenosis is a narrowing of the aortic valve opening, which decreases blood flow from the heart and causes…
- Conditions
- Aortic Valve Stenosis, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases
- Trial name
- NCT02732691
- Testing
- JenaValve Pericardial TAVR System
- Where
- 13 sites in United States, Germany and 2 more
- Volunteers
- 68 people
- Sponsor
- JenaValve Technology, Inc.
AAA, AAA - Abdominal Aortic Aneurysm
JAGUAR Trial (Outside United States; OUS): ObJective Analysis to GaUge EVAR Outcomes Through Randomization
Prospective, randomized, multi-center study designed to evaluate the outcomes of commercially available contemporary EVAR in a real-world population.
- Trial name
- NCT05409118
- Testing
- Alto Abdominal Stent Graft System, FDA Approved EVAR AAA Graft Systems
- Sponsor
- Endologix
Aortic Valve Disease
Avalus Ultra Post-Approval Study (PAS)
The purpose of this study is to characterize the safety and effectiveness of the Medtronic Avalus Ultra aortic valve bioprosthesis in patients with aortic valve disease.
- Trial name
- NCT06506903
- Testing
- Medtronic Avalus Ultra
- Where
- 15 sites in United States
- Volunteers
- 190 people
- Sponsor
- Medtronic Cardiac Surgery
Aortic Aneurysm, Abdominal, Juxtarenal Aortic Aneurysm
Zenith® Fenestrated+ Clinical Study
The Zenith® Fenestrated+ Endovascular Graft Clinical Study will assess the safety and effectiveness of the Zenith® Fenestrated+ Endovascular Graft (ZFEN+) in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent…
- Conditions
- Aortic Aneurysm, Abdominal, Juxtarenal Aortic Aneurysm, Extent IV Thoracoabdominal, Pararenal Aneurysm
- Trial name
- NCT04875429
- Testing
- Zenith Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System and Unibody2
- Where
- 33 sites in United States, United Kingdom
- Volunteers
- 105 people
- Sponsor
- Cook Research Incorporated
Aortic Dissection Aneurysm
Guo's False Lumen Embolization : The First in Man Study of WeFlow-EndoSeal Aorta Vascular Plug System
A prospective, single-center, first in man study to evaluate the safety and efficacy of WeFlow-EndoSeal Aorta Vascular Plug System manufactured by Hangzhou Endonom Medtech Co., Ltd.
- Trial name
- NCT06062524
- Testing
- Aorta Vascular Plug System
- Where
- 3 sites in China
- Volunteers
- 20 people
- Sponsor
- Hangzhou Endonom Medtech Co., Ltd.
Aortic Valve Disease, Aortic Stenosis
Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement
Prospective, randomized, stratified non blinded multi-center, international, post market trial assessed in a non-inferiority study. The trial has a flexible sample size that will be determined adaptively.
- Trial name
- PERSIST-AVR (NCT02673697)
- Testing
- Perceval valve, other stented biological valve
- Where
- 47 sites in United States, Austria and 10 more
- Volunteers
- 914 people
- Sponsor
- Corcym S.r.l
Aortic Valve Disease, Aortic Valve Stenosis
PERCEVAL S Valve Clinical Study for Chinese Registration
This is a prospective, open, single arm, multi-center clinical study in China. The primary objective of this study is to demonstrate the safety and effectiveness of the PERCEVAL S heart valve when used to replace a diseased…
- Trial name
- PERFECT (NCT03481387)
- Testing
- Aortic Valve Replacement with Perceval S sutureless heart valve
- Where
- China
- Volunteers
- 61 people
- Sponsor
- Corcym S.r.l
Aortic Valve Disease, Aortic Valve Stenosis
PROACT Xa - A Trial to Determine if Participants With an On-X Aortic Valve Can be Maintained Safely on Apixaban
Currently, warfarin is the only approved anticoagulation for patients with mechanical valves. The purpose of this study is to determine if participants with an On-X Prosthetic Heart Valve / On-X aortic valve can be maintained…
- Conditions
- Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Failure
- Trial name
- NCT04142658
- Testing
- Apixaban 5 MG, Apixaban 2.5 MG, Warfarin
- Where
- 62 sites in United States
- Volunteers
- 863 people
- Sponsor
- Artivion Inc.
Cardiac Rhythm Disorders, Urological Disorders
Product Surveillance Registry
The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products.
- Conditions
- Cardiac Rhythm Disorders, Urological Disorders, Neurological Disorders, Cardiovascular Disorders
- Trial name
- PSR (NCT01524276)
- Where
- 402 sites in United States, Argentina and 39 more
- Volunteers
- 100,000 people
- Sponsor
- Medtronic
Symptomatic Hypertrophic Cardiomyopathy (HCM)
Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM
The purpose of this study is to collect long-term safety and tolerability data for aficamten.
- Trial name
- FOREST-HCM (NCT04848506)
- Testing
- Aficamten (5 - 20 mg)
- Where
- 141 sites in United States, Argentina and 17 more
- Volunteers
- 900 people
- Sponsor
- Cytokinetics
Severe Aortic Stenosis, Transcatheter Aortic Valve Replacement
Open-label, Randomized Trial in Participants Undergoing TAVR to Determine Safety & Efficacy of Bivalirudin vs UFH
The objective of this study is to assess the safety and efficacy of using bivalirudin instead of unfractionated heparin (UFH) in transcatheter aortic valve replacements (TAVR).
- Conditions
- Severe Aortic Stenosis, Transcatheter Aortic Valve Replacement, Aortic Valve Replacement
- Trial name
- BRAVO 2/3 (NCT01651780)
- Testing
- Bivalirudin, Unfractionated Heparin
- Where
- 33 sites in Canada, France and 5 more
- Volunteers
- 803 people
- Sponsor
- The Medicines Company
Heart Valve Diseases
Clinical Investigation of the Freedom SOLO Stentless Heart Valve
This is a trial to demonstrate the safety and effectiveness of the Freedom SOLO heart valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.
- Trial name
- NCT00876525
- Testing
- Surgical Replacement of the diseased native aortic heart valve with the Freedom SOLO Valve prosthesis
- Where
- 19 sites in Austria, Belgium and 6 more
- Volunteers
- 702 people
- Sponsor
- Corcym S.r.l
Abdominal Aortic Aneurysm
The Long-Term EVAR Assessment and Follow-Up (LEAF) Study for the AFX2 System
This is an observational, retrospective, multicenter study to evaluate the performance of the AFX2 System using real world evidence from VQI-VISION.
- Trial name
- LEAF (NCT06990048)
- Testing
- AFX2 System
- Where
- United States
- Volunteers
- 2,000 people
- Sponsor
- Endologix
Aortic Valve Stenosis
A Registry to Evaluate the Direct Flow Medical Transcatheter Aortic Valve System
The purpose of this postmarket Registry is to assess the standard of care and clinical outcomes of the Direct Flow Medical Transcatheter Aortic Valve System used in clinical routine according to the approved commercial…
- Trial name
- DISCOVER (NCT01845285)
- Testing
- Aortic Valve Replacement
- Where
- 2 sites in Germany, Italy
- Volunteers
- 1,000 people
- Sponsor
- Direct Flow Medical, Inc.
Abdominal Aortic Aneurysm
A Phase I Evaluation of the Safety of the TriVascular Stent-Graft System in the Treatment of Abdominal Aortic Aneurysms
This study was a prospective observational study examined the safety of the TriVascular AAA Stent-Graft System in the elective treatment of patients with abdominal aortic aneurysms.
- Trial name
- AAA IDE (NCT00646048)
- Testing
- TriVascular Stent-Graft System
- Where
- 7 sites in United States
- Volunteers
- 43 people
- Sponsor
- Boston Scientific Corporation
Hypertension
An Active-controlled, Clinical Trial to Assess Central Hemodynamic Effects of Bisoprolol in Hypertensive Patients (Central Hemodynamic Assessment Measured in Patient With HypertensION [CHAMPION])
Antihypertensive drugs aim to reduce blood pressure (BP) either through decrease of the total peripheral resistance through vasodilatation at the level of arterioles (microcirculation) or by decreasing the cardiac output through…
- Trial name
- NCT01079962
- Testing
- Bisoprolol, Atenolol
- Where
- South Korea
- Volunteers
- 209 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Aneurysm of Aortic Arch
Early Feasibility of the Branched TAG® Device in the Treatment of Aortic Arch Aneurysms
The purpose of this study is to assess the early feasibility of the use of the GORE® TAG® Thoracic Branch Endoprosthesis to treat aneurysms involving the aortic arch
- Trial name
- NCT02264977
- Testing
- GORE® TAG® Thoracic Branch Endoprosthesis
- Where
- 6 sites in United States
- Volunteers
- 9 people
- Sponsor
- W.L.Gore & Associates
Aortic Dissection
Safety and Efficacy Study Of The Thoracic Aortic Stent Graft System Treating Aortic Dissection
This is a prospective, multicenter and single-arm trail to study the safety and efficacy of the thoracic aortic stent graft system that specially designed for treating aortic dissection.
- Trial name
- NCT05430672
- Testing
- The Thoracic Aortic Stent Graft System (Zylox-Tonbridge Medical Technology Co., Ltd. )
- Where
- 14 sites in China
- Volunteers
- 120 people
- Sponsor
- Zhejiang Zylox Medical Device Co., Ltd.