Clinical trials: Aortic Valve Surgery
Severe Aortic Stenosis
Colibri Transcatheter Aortic Heart Valve System Study
The Colibri Heart Valve clinical investigation ("COL-01") is a prospective, multicenter, exploratory single arm and controlled clinical investigation compared to recent historical results.
- Trial name
- NCT04029844
- Testing
- Colibri TAVI System
- Where
- 5 sites in France, United Kingdom
- Volunteers
- 30 people
- Sponsor
- Colibri Heart Valve LLC
Aortic Valve Stenosis, Aneurysm of Ascending Aorta
Progel Vascular Sealant
This study is being conducted to evaluate the safety and effectiveness of the Progel Vascular Sealant for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
- Conditions
- Aortic Valve Stenosis, Aneurysm of Ascending Aorta, Aortic Valve Disorder, Bicuspid Valve Disorder
- Trial name
- NCT01959503
- Testing
- Progel Vascular Sealant, Gelfoam Plus
- Where
- 19 sites in United States
- Volunteers
- 158 people
- Sponsor
- C. R. Bard
Aortic Stenosis, Bicuspid Aortic Valve (BAV)
TAVR vs. SAVR Study of VitaFlow Liberty® for Severe BAV Stenosis
To evaluate the safety and effectiveness of the Transcatheter aortic valve and retrievable delivery system (VitaFlow Liberty®) for the treatment of severe bicuspid aortic valve (BAV) stenosis.
- Trial name
- PROMIS-BAV (NCT06597188)
- Testing
- VitaFlow Liberty, Commercially available surgical bioprosthetic valve
- Where
- China
- Volunteers
- 452 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
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
Aortic Valve Stenosis
REPRISE IV: LOTUS Edge Valve System in Intermediate Surgical Risk Subjects
REPRISE IV: REpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of LOTUS Edge Valve System in IntermediatE Surgical Risk Subjects
- Trial name
- REPRISE IV (NCT03618095)
- Testing
- LOTUS Edge Valve System
- Where
- 50 sites in United States, Australia
- Volunteers
- 382 people
- Sponsor
- Boston Scientific Corporation
Surgical Site Infection, Sternal Infection
D-PLEX 302: Efficacy and Safety of D-PLEX in the Prevention of Sternal Infection Post Cardiac Surgery
Prospective, Multinational, Multicenter, Randomized, Parallel Controlled, Two arms, Single Blind, Study to Assess the Efficacy and Safety of D-PLEX Administered Concomitantly with the Standard of Care (SOC) IV Prophylactic…
- Conditions
- Surgical Site Infection, Sternal Infection, Cardiac Surgery
- Trial name
- NCT03558984
- Testing
- D-PLEX, Standard of Care
- Where
- 3 sites in United States, Israel
- Volunteers
- 2 people
- Sponsor
- PolyPid Ltd.
Aortic Valve Disease, Coronary Artery Disease (CAD)
Phase III Study Comparing Two Methods of Cardioplegia in Aortic Valve Surgery Custodiol-N Versus Custodiol
The objective of this investigation is to compare the cardioprotective effects and safety of two cardioplegic solutions, HTK Cardioplegic Solution (Custodiol) and Custodiol-N in patients undergoing aortic valve surgery.
- Trial name
- Custodiol-AV (NCT02098772)
- Testing
- Custodiol-N, Custodiol
- Where
- 6 sites in Germany
- Volunteers
- 530 people
- Sponsor
- Dr. F. Köhler Chemie GmbH
Aortic Valve Stenosis, Aortic Valve Calcification
Safety and Performance of TAVI of Venus MedTech Aortic Valve Prosthesis
1. objectives Evaluate the performance of Venus MedTech aortic valve prosthesis intervention by femoral artery Evaluate safety and clinical benefit of percutaneous implantation of the Venue MedTech aortic valve prosthesis.
- Trial name
- Venus-A (NCT01683474)
- Testing
- Venus MedTech Aortic Valve Prosthesis
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Venus MedTech (HangZhou) Inc.
Aortic Valve Stenosis
Clinical Evaluation of Percutaneous Implantation of the Medtronic CoreValve Aortic Valve Prosthesis (18Fr-Study)
The investigation concerns a prospective, multicenter, single arm safety and performance study evaluating the Medtronic CoreValve system.
- Trial name
- NCT01051518
- Testing
- Medtronic CoreValve System
- Where
- 9 sites in Canada, Germany and 2 more
- Volunteers
- 126 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Aortic Valve Stenosis With Insufficiency, Aortic Valve Stenosis
Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve
The purpose of this clinical investigation is to confirm that the safety and performance of the EDWARDS INTUITY Valve System.
- Trial name
- TRITON (NCT01445171)
- Testing
- Aortic Valve Replacement with EDWARDS INTUITY Valve System
- Where
- 6 sites in Austria, Germany
- Volunteers
- 295 people
- Sponsor
- Edwards Lifesciences
Mitral Valve or Aortic Valve Replacement
Clinical Study to Evaluate the Performance of Perimount Heart Valve in Chinese Patients
To recruit patients who implanted with Perimount Heart Valve (Type Number: 6900PTFX or 2800TFX) from three hospitals in China. To track the patients'situations during one year after surgery and to collect the relevant clinical…
- Trial name
- NCT02400489
- Where
- 3 sites in China
- Volunteers
- 265 people
- Sponsor
- Edwards Lifesciences
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