Clinical trials: Cardiac Surgical Procedure
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
Cardiac Surgical Procedures
Pilot Study of the Genius(TM)2 Tympanic Thermometer in Cardiac Patients Requiring Cardiopulmonary Bypass
Primary study objective is to test the accuracy of the Genius 2 tympanic thermometer and the Exergen TAT-5000(TM) temporal artery thermometer as compared with serial perioperative core temperature measurements obtained in cardiac…
- Trial name
- NCT01029314
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Tyco Healthcare Group
Post-Operative Atrial Fibrillation
Botulinum Toxin Type A (AGN-151607) for the Prevention of Post-operative Atrial Fibrillation in Adult Participants Undergoing Open-chest Cardiac Surgery (NOVA)
This was a multi-center, randomized, double-blind, placebo-controlled, parallel group, dose-ranging study to evaluate the efficacy and safety of botulinum toxin type A (AGN-151607) injections into the epicardial fat pads, foci of…
- Trial name
- NCT03779841
- Testing
- AGN-151607
- Where
- 32 sites in United States, Austria and 7 more
- Volunteers
- 323 people
- Sponsor
- AbbVie
Coronary Artery Disease
SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries
The SYNTAX trial is designed to determine the best treatment for patients with complex coronary disease (blocked or narrowed arteries in both the right and left sides of the heart) by randomizing patients to receive either…
- Trial name
- SYNTAX (NCT00114972)
- Testing
- Polymer-based Paclitaxel-Eluting TAXUS Express2-SR Stent, Coronary Artery Bypass Surgery
- Where
- 106 sites in United States, Austria and 16 more
- Volunteers
- 1,800 people
- Sponsor
- Boston Scientific Corporation
Mitral Regurgitation
Expanded Study of the HighLife 28mm Trans-septal Trans-catheter Mitral Valve in Patients With Moderate-severe or Severe Mitral Regurgitation and at High Surgical Risk
to evaluate the safety and performance of the HighLife 28mm transcatheter, trans-septal Mitral Valve in patients with moderate-severe or severe mitral regurgitation who are at high risk for surgical treatment.
- Trial name
- NCT04029363
- Testing
- HighLife Transcatheter Mitral Valve Replacement
- Where
- 50 sites in Australia, Belgium and 5 more
- Volunteers
- 120 people
- Sponsor
- HighLife SAS
Mitral Regurgitation
Feasibility Study of Patients With Severe MR Treated With the Cardiovalve TMVR System
The study will test the safety and performance of the Cardiovalve transfemoral mitral valve replacement system in treating patients with severe mitral regurgitation who are at high risk for open chest surgery.
- Trial name
- NCT03714412
- Testing
- Implantation
- Where
- 2 sites in Greece, Poland
- Sponsor
- Cardiovalve Ltd.
Acquired Antithrombin Deficiency
Phase 3 Study on the Efficacy and Safety of Human Plasma Derived Antithrombin (Atenativ) in Heparin-Resistant Patients Scheduled to Undergo Cardiac Surgery Necessitating Cardiopulmonary Bypass
The primary objective of this study is to evaluate the efficacy of two different doses of Atenativ, versus placebo, in restoring and maintaining heparin responsiveness in adult patients undergoing cardiac surgery necessitating…
- Trial name
- NCT06096116
- Testing
- Human plasma derived antithrombin
- Where
- 27 sites in United States, Austria and 8 more
- Volunteers
- 120 people
- Sponsor
- Octapharma
Aortic Stenosis, Aortic Stenosis, Severe
PARTNER 3 Trial - Aortic Valve-in-Valve
This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.
- Trial name
- NCT03003299
- Testing
- Edwards SAPIEN 3/SAPIEN 3 Ultra THV
- Where
- 51 sites in United States, Canada
- Volunteers
- 125 people
- Sponsor
- Edwards Lifesciences
Cardiac Surgery
Efficacy and Safety of Sodium Heparin in Patients Submitted to Heart Surgery Using Bypass
The objective of this study is to verify, through a randomized, single-blind, multicentre, parallel and comparative study, the effectiveness of heparin sodium of porcine origin in patients undergoing heart surgery that require…
- Trial name
- NCT00905216
- Testing
- heparin sodium - Bergamo, heparin sodium - APP
- Where
- Brazil
- Volunteers
- 104 people
- Sponsor
- Azidus Brasil
Systemic Inflammation, Cardiopulmonary-bypass
Preventing Systemic Inflammation After Cardiac Surgery With Alkaline Phosphatase
Study should demonstrate that alkaline phosphatase reduces the incidence and extent of acute kidney injury after cardiopulmonary bypass (CPB) as defined by the AKIN criteria.
- Trial name
- APPIRED-III (NCT03050476)
- Testing
- RESCAP®
- Where
- 21 sites in Australia, Austria and 9 more
- Volunteers
- 1,250 people
- Sponsor
- Alloksys Life Sciences B.V.
Cardiac Surgery
RECOVER I Impella RECOVER LP/LD 5.0 Support System Safety and Feasibility Study
To demonstrate that that the device is safe and potentially efficacious for use as a left ventricular cardiac assist device for postcardiotomy patients who require hemodynamic support post weaning from cardiopulmonary bypass.
- Trial name
- RECOVER I (NCT00596726)
- Testing
- IMPELLA LP/LD 5.0
- Where
- 7 sites in United States
- Volunteers
- 17 people
- Sponsor
- Abiomed Inc.
Cardiac Surgery Associated - Acute Kidney Injury, AKI - Acute Kidney Injury
Safety & Efficacy of RenalGuard® Therapy in the Prevention of Cardiac Surgery Associated Acute Kidney Injury
The goal of this clinical trial is to assess the effect of RenalGuard Therapy in reducing the rates of Acute Kidney Injury (AKI) within 72 hours after cardiac surgery in patients at risk of developing Cardiac Surgery Associated…
- Trial name
- SAFEGUARD (NCT07123935)
- Testing
- RenalGuard® Therapy, Standard of Care (SOC)
- Where
- 2 sites in Malaysia
- Volunteers
- 300 people
- Sponsor
- CardioRenal Systems, Inc.
Aortic Aneurysm, Aortic Aneurysm Abdominal
Prophylactic Suture Line Sealing With NE'X Glue R-eco in Cardiac and Vascular Surgery
This clinical study aims to evaluate the effectiveness and safety of using NE'X Glue R-eco to seal suture lines. The adhesive will be applied to reduce the risk of suture line bleeding in cardiac or vascular repair surgeries, a…
- Conditions
- Aortic Aneurysm, Aortic Aneurysm Abdominal, Valve Stenoses, Aortic, Valve Regurgitation, Mitral
- Trial name
- CLOSURE (NCT06918496)
- Testing
- Surgical placement of a prosthetic or biologic graft (patch), or an allograft for cardiac and (cardio)vascular repair.
- Where
- 2 sites in Belgium, Poland
- Volunteers
- 60 people
- Sponsor
- Grena Biomed Limited
Coronary Artery Bypass Surgery, Coronary Heart Disease
Clinical Study to Evaluate Nesiritide in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery A014 / NAPA
The purpose of this study is to assess the effects of nesiritide compared to placebo when given with standard of care therapies, on kidney function, heart function and the need of other treatments in heart failure patients…
- Conditions
- Coronary Artery Bypass Surgery, Coronary Heart Disease, Coronary Artery Bypass Grafting, Cardiopulmonary Bypass
- Trial name
- NCT00653042
- Testing
- Nesiritide
- Volunteers
- 305 people
- Sponsor
- Scios, Inc.
Hemodynamic Monitoring, ICU
Automated Inferior Vena Cava Collapsibility Index Fluid Responsiveness in Ventilated Patients After Cardiac Surgery.
Echocardiographic measurement of inferior vena cava (IVC) collapsibility index (CI) with automated software analyses has been introduced.
- Conditions
- Hemodynamic Monitoring, ICU, Cardiac Surgery
- Trial name
- NCT05283590
- Testing
- Automated echocardiographic inferior vena cava measurement
- Where
- Qatar
- Volunteers
- 50 people
- Sponsor
- Hamad Medical Corporation
Cardiac Surgery, Thoracic Surgery
Heart Lung Machine Registry
The HeaLMe post-market clinical follow-up registry is undertaken to evaluate the safety and performance of the index devices Heart Lung Machine HL 40 and Temperature Probes TPO-D-HLM L1.8 Adult / Pediatric in patients undergoing…
- Conditions
- Cardiac Surgery, Thoracic Surgery, Vascular Surgery, Cardiopulmonary Bypass
- Trial name
- HeaLMe (NCT06159517)
- Where
- 3 sites in Italy, Spain
- Volunteers
- 184 people
- Sponsor
- Maquet Cardiopulmonary GmbH
Acute Kidney Injury
A Study of THR-184 in Patients at Risk of Developing Cardiac Surgery Associated-Acute Kidney Injury (CSA-AKI)
The purpose of this study is to determine whether THR-184 when administered around the time of cardiac surgery that requires cardiopulmonary bypass can prevent or ameliorate the development of acute kidney injury.
- Trial name
- NCT01830920
- Testing
- THR-184
- Where
- 41 sites in United States, Canada
- Volunteers
- 452 people
- Sponsor
- Thrasos Innovation, Inc.
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
Critical Illness
Feasibility of Blood Glucose Control With the Space TGC System in Postoperative Cardiac Surgery Patients in the ICU
Hyperglycemia is common in critically ill patients and associated with an adverse outcome. Thus, glycaemic control is an important issue in critical care.
- Trial name
- DELIOS 02 (NCT01233271)
- Testing
- Space TGC
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- B. Braun Melsungen AG
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
- 40 sites in United States
- Volunteers
- 1,016 people
- Sponsor
- JenaValve Technology, Inc.