Clinical trials: Aortic Surgery
Aortic Stenosis, Aortic Insufficiency
First in Human Feasibility Study With ADAPT 3D - ALR for Aortic Leaflet Repair
This study will evaluate the safety and performance of the ADAPT 3D - ALR in adult patients requiring replacement of aortic valve. 15 patients in one site in Belgium will all be treated with ADAPT 3D - ALR.
- Trial name
- NCT04178213
- Testing
- Implantation of ADAPT 3D ALR
- Where
- Belgium
- Volunteers
- 15 people
- Sponsor
- Anteris Technologies Ltd.
Transcatheter Aortic Valve Implantation
NVT ALLEGRA TAVI System TF in Failing Calcified Aortic Heart Valves in a Real-world Patient Population
The study collects real-world data of patients who were treated with the ALLEGRA TAVI System TF and evaluates early and midterm clinical and quality of life outcome.
- Trial name
- FOLLOW (NCT03613246)
- Where
- 14 sites in Finland, Germany and 4 more
- Volunteers
- 346 people
- Sponsor
- NVT GmbH
Transcatheter Aortic Valve Implantation
Investigation of the ALLEGRA THV System With a New Delivery System in Patients With Aortic Stenosis or Failed Surgical Bioprosthesis
The EMPIRE study confirms the technical performance of the new IMPERIA Delivery System and evaluates the safety and efficacy of the entire ALLEGRA THV System.
- Trial name
- EMPIRE (NCT05478161)
- Testing
- (ALLEGRA Transcatheter Heart Valve) TAVI in severe calcified aortic stenosis or in failed surgical aortic bioprosthesis
- Where
- 11 sites in Germany, Netherlands and 1 more
- Volunteers
- 137 people
- Sponsor
- NVT GmbH
Aortic Valve Stenosis
Prizvalve Pro™ Transcatheter Aortic Valve Replacement Study
The purpose of this clinical trial is to evaluate the safety and efficacy of the Prizvalve Pro™ transcatheter aortic valve system in the treatment of patients with severe aortic stenosis who are at high risk of surgery or who are…
- Trial name
- NCT05864456
- Testing
- Prizvalve Pro™ transcatheter aortic valve system
- Where
- China
- Volunteers
- 73 people
- Sponsor
- Shanghai NewMed Medical Co., Ltd.
Aortic Valve Disease, Cardiovascular Diseases
A Prospective Multicenter Pivotal Study to Evaluate Safety and Effectiveness of Venus-Neo Surgical Aortic Valve
The goal of this clinical trial is to evaluate the safety, effectiveness, and performance of Venus-Neo Surgical Aortic Valve in subjects who are clinically indicated for aortic valve replacement.
- Trial name
- METASAR (NCT05941455)
- Testing
- Venus-Neo Surgical Aortic Valve
- Where
- Germany
- Volunteers
- 155 people
- Sponsor
- Jilin Venus Haoyue Medtech Limited
Cardiac Surgery, Coronary Artery Bypass
An Trial of Two Dosing Regimens of AP214 for the Prevention of Kidney Injury in Patients Undergoing Cardiac Surgery
This study investigates the effect of two dose-levels of AP214 on the prevention of (acute) kidney injury after cardiac surgery.
- Conditions
- Cardiac Surgery, Coronary Artery Bypass, Aortic Aneurysm, Valve Surgery
- Trial name
- NCT01256372
- Testing
- AP214
- Where
- Denmark
- Volunteers
- 77 people
- Sponsor
- Action Pharma A/S
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 Stenosis
EDWARDS INTUITY Valve System CADENCE Study
The study purpose is to compare the EDWARDS INTUITY valve system with commercially available stented aortic bioprostheses, in patients requiring aortic valve replacement surgery with coronary artery bypass.
- Trial name
- CADENCE (NCT02688153)
- Testing
- EDWARDS INTUITY, Stented aortic bioprostheses
- Where
- France
- Volunteers
- 120 people
- Sponsor
- Edwards Lifesciences
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
Cardiac Surgery, Heart Surgery
Safety and Performance Evaluation of CPB Venous and Arterial Cannulas
This is a two-phase study evaluating the Eurosets arterial and venous cannulas for use during cardiopulmonary bypass (CPB) procedures. Phase 1 is a pilot study focused on assessing cannula safety.
- Conditions
- Cardiac Surgery, Heart Surgery, Cardiopulmonary Bypass, Coronary Surgery
- Trial name
- NCT07354841
- Testing
- Eurosets Venous and Arterial Cannula, Control Arterial and Venous Cannulas
- Where
- Italy
- Volunteers
- 80 people
- Sponsor
- Eurosets S.r.l.
Aortic-valve Replacement
Behavior of Valve Leaflets Following Aortic Valve Implant
This is a prospective, interventional, multi-center trial to report the overall incidence of reduced leaflet motion identified by CT imaging in patients receiving a commercially approved LivaNova bioprosthetic aortic heart valve…
- Trial name
- BELIEVE (NCT03200574)
- Testing
- 4D Cardiac CT Scan, LivaNova Bioprothetic Aortic Valve Implant
- Where
- 11 sites in United States, Canada
- Volunteers
- 88 people
- Sponsor
- Corcym S.r.l
Aortic Regurgitation, Aortic Valve Insufficiency
ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™
To demonstrate non-inferiority of the Trilogy Transcatheter Heart Valve (THV) System compared with surgical aortic valve replacement (SAVR) for treatment of subjects with clinically significant native aortic regurgitation (AR)
- Conditions
- Aortic Regurgitation, Aortic Valve Insufficiency, Aortic Insufficiency
- Trial name
- ARTIST (NCT06608823)
- Testing
- Transcatheter Aortic Valve Replacement (TAVR) using Trilogy THV System, SAVR
- Where
- 38 sites in United States
- Volunteers
- 1,016 people
- Sponsor
- JenaValve Technology, Inc.
Symptomatic Severe Aortic Stenosis
Portico Next Generation Approval Study
The purpose of this clinical study is to evaluate the acute safety and effectiveness of the next-generation Navitor (Portico™ NG) Transcatheter Aortic Heart Valve as assessed by the rate of all-cause mortality at 30 days and the…
- Trial name
- NCT04011722
- Testing
- Portico™ NG (Navitor) Valve and FlexNav™ Delivery System, Navitor Titan Valve (35mm) Valve and Large FlexNav™ Delivery System
- Where
- 28 sites in United States, Australia and 3 more
- Volunteers
- 333 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Stenosis
Transapical Implantation of the Medtronic Engager Transcatheter Aortic Valve Implantation System - The Engager European Pivotal Trial
The purpose of the study is to evaluate the safety and clinical performance of the Engager Transcatheter Aortic Valve Implantation System in patients with severe aortic valve stenosis who are at high risk for surgical valve…
- Trial name
- NCT01348438
- Testing
- Medtronic Engager Transcatheter Aortic Valve Implantation System
- Where
- 9 sites in Belgium, Germany and 2 more
- Volunteers
- 125 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Aortic Valve Insufficiency, Regurgitation, Aortic Valve
Aortic Valve Replacement With Trifecta(TM)
The purpose of this study is to confirm the clinical safety and effectiveness of the Trifecta valve.
- Conditions
- Aortic Valve Insufficiency, Regurgitation, Aortic Valve, Aortic Valve Incompetence, Aortic Valve Stenosis
- Trial name
- NCT00475267
- Testing
- Trifecta aortic heart valve
- Where
- 5 sites in Canada
- Volunteers
- 203 people
- Sponsor
- Abbott Medical Devices
AORTIC VALVE DISEASES, Aortic Valve Stenosis and Insufficiency
Post-market Safety and Performance Outcomes of the VIVERE® Bovine Pericardial Bioprosthetic Valve
This study aims to collect post-market safety and performance data related to the procedure and follow-up of the VIVERE Bovine Pericardial Bioprosthetic Valve, when used in accordance with the product's Instructions for Use (IFU).
- Conditions
- AORTIC VALVE DISEASES, Aortic Valve Stenosis and Insufficiency, Aortic Valve Surgery, Mitral Valve Regurgitation
- Trial name
- VITTA (NCT06959836)
- Testing
- VIVERE Bovine Pericardial Bioprosthetic Valve
- Where
- 3 sites in Brazil
- Volunteers
- 150 people
- Sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda.
Patients With History of Ischemic Heart Disease With LV Dysfunction Undergoing Noncardiac Surgery
ACTIONS - Aortic Counterpulsation to Improve Outcomes in Noncardiac Surgery
The use of the IABP, in addition to standard care, in high-risk cardiac patients undergoing major noncardiac surgery is feasible and may result in improved perioperative outcomes at 30 days compared with standard care alone…
- Trial name
- ACTIONS (NCT01253356)
- Testing
- IABP
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Datascope Corp.
Aortic Valve Disease, Aortic Stenosis
EDWARDS INTUITY Elite Valve System
The purpose of this active, observational, open-label, non-randomized, post-market surveillance study is to confirm that EDWARDS INTUITY Elite reduces cross clamp time (XCT) in MIS setting when compared to published data with a…
- Trial name
- MISSION (NCT02907463)
- Where
- 23 sites in Austria, Denmark and 7 more
- Volunteers
- 280 people
- Sponsor
- Edwards Lifesciences
Elective Cardiac Surgery
Pleiades Safety and Feasibility Study
The "Pleiades" study is a non randomised, prospective, single center clinical trial that aims to evaluate the safety and the procedural feasibility of an innovative flow assist device (Pleioflow-RF) in adult patients undergoing…
- Trial name
- NCT05662501
- Testing
- Pleioflow-RF
- Where
- Greece
- Volunteers
- 40 people
- Sponsor
- Pleioflow
Aortic Valve Stenosis
CoreValve VIVA Study Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis.
This observational study is intended to collect real-world (post-approval use) data regarding the clinical utility and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI).
- Trial name
- NCT02209298
- Testing
- CoreValve Transcatheter Valve
- Where
- 25 sites in France, Germany and 2 more
- Volunteers
- 202 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure