Clinical trials: Cardiac Surgery
Atrial Fibrillation
AtriCure Bipolar Radiofrequency Ablation of Permanent Atrial Fibrillation
ABLATE is a prospective, non-randomized multi-center clinical trial to demonstrate the safety and effectiveness of the AtriCure Bipolar System for treating permanent atrial fibrillation during concomitant on-pump cardiac surgery.
- Trial name
- ABLATE (NCT00560885)
- Testing
- AtriCure Bipolar System
- Where
- 9 sites in United States
- Volunteers
- 55 people
- Sponsor
- AtriCure, Inc.
Deep Vein Thrombosis, Fibrillation, Atrial
Odiparcil For The Prevention Of Venous Thromboembolism
Odiparcil is being studied to determine if it can prevent blood clots from forming after a total knee replacement and also to prove that odiparcil is safe.
- Conditions
- Deep Vein Thrombosis, Fibrillation, Atrial, Venous Thromboembolism, Pulmonary Embolism
- Trial name
- NCT00244725
- Testing
- Odiparcil, Warfarin, Coumadin
- Where
- 101 sites in United States, Australia and 11 more
- Volunteers
- 961 people
- Sponsor
- GlaxoSmithKline
Bicuspid Aortic Valve
Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk Bicuspid Study
The objective of the trial is to evaluate the procedural safety and efficacy of the Medtronic TAVR system in patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR
- Trial name
- NCT03635424
- Testing
- Medtronic TAVR Systems
- Where
- 25 sites in United States
- Volunteers
- 150 people
- Sponsor
- Medtronic Cardiovascular
Anemia
Study to Evaluate the Efficacy & Safety of the INTERCEPT Blood System for RBCs in Complex Cardiac Surgery Patients
The objective of this study is to evaluate the efficacy and safety of RBC transfusion for support of acute anemia in cardiovascular surgery patients based on the clinical outcome of renal impairment following transfusion of red…
- Trial name
- ReCePI (NCT03459287)
- Testing
- INTERCEPT, Control
- Where
- 18 sites in United States
- Volunteers
- 581 people
- Sponsor
- Cerus Corporation
Aortic Valve Stenosis, Aortic Valve Stenosis With Insufficiency
Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve
The purpose of the clinical study is to prove that the heart valve device is safe, effective, and performs as intended.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Stenosis With Insufficiency, Regurgitation, Aortic Valve, Aortic Valve Incompetence
- Trial name
- TRANSFORM™ (NCT01700439)
- Testing
- EDWARDS INTUITY valve
- Where
- 29 sites in United States
- Volunteers
- 934 people
- Sponsor
- Edwards Lifesciences
Hemorrhage, Surgical, Blood Loss, Surgical
Safe and Timely Antithrombotic Removal - Ticagrelor (STAR-T)
Prospective, multi-center, double-blind, randomized pivotal trial to evaluate the safety and effectiveness of the DrugSorb-Antithrombotic Removal (ATR) system for intraoperative removal of ticagrelor in patients undergoing urgent…
- Conditions
- Hemorrhage, Surgical, Blood Loss, Surgical, Blood Loss, Postoperative, Hemorrhage Postoperative
- Trial name
- STAR-T (NCT04976530)
- Testing
- DrugSorb-ATR system
- Where
- 29 sites in United States, Canada
- Volunteers
- 140 people
- Sponsor
- CytoSorbents, Inc
Elective Cardiac Surgery
CytoSorb Reduction of Free Hemoglobin During Cardiac Surgery
Prospective, multi-center, randomized, feasibility clinical study. Subjects will be randomized in a 1:1 ratio to either standard of care (SOC) alone or standard of care and treatment with the CytoSorb® device.
- Trial name
- REFRESH (NCT02566525)
- Testing
- CytoSorb
- Where
- 8 sites in United States
- Volunteers
- 52 people
- Sponsor
- CytoSorbents, Inc
Surgery, Pneumonia
Multicenter Infection Surveillance Study Following Open Heart Surgery
The main goals of the study are as follows: (1) to determine the correlation between pain management using continuous infusion of local anesthetics and the incidence of pneumonia and surgical infection in cardiac surgery…
- Conditions
- Surgery, Pneumonia, Surgical Site Infection
- Trial name
- NCT00673712
- Testing
- Continuous Sternal Block, Opioid based analgesia
- Where
- 8 sites in United States
- Volunteers
- 647 people
- Sponsor
- Halyard Health
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
Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation
ABLATE Post Approval Study - Synergy Ablation Lesions for Non-Paroxysmal Atrial Fibrillation
The primary objective of this post-approval study is to evaluate the clinical outcomes in a cohort of patients with non-paroxysmal forms of atrial fibrillation (persistent or long-standing persistent) treated during commercial…
- Trial name
- ABLATE-PAS (NCT01694563)
- Testing
- Synergy Ablation System
- Where
- 49 sites in United States
- Volunteers
- 365 people
- Sponsor
- AtriCure, Inc.
Cardiac Surgery, Cardiopulmonary Bypass
Voluven® in Paediatric Patients
This study will compare the clinical efficacy and safety of Voluven® and Human Albumin during elective open-heart surgery in pediatric patients.
- Trial name
- NCT00860405
- Testing
- HES 130/0.4 (6%) in sodium chloride (Voluven®, solution for infusion), Human serum albumin (HSA 50g/L), Human serum albumin (HSA 50g/L)
- Where
- 2 sites in Austria, Belgium
- Volunteers
- 61 people
- Sponsor
- Fresenius Kabi
Acute Kidney Injury (AKI)
A Study to Evaluate RMC-035 in Subjects Undergoing Cardiac Surgery
The purpose of the clinical study is to assess safety, tolerability and pharmacokinetics of RMC-035 for the prevention and treatment of acute kidney injury (AKI) in patients undergoing cardiac surgery.
- Trial name
- NCT04829916
- Testing
- RMC-035
- Where
- Germany
- Volunteers
- 13 people
- Sponsor
- Guard Therapeutics AB
Cardiac Surgical Procedures, Hemorrhage
A Premarket, Prospective, Randomized, Single-Blind Study to Compare the Veriset™ Hemostatic Patch to TachoSil® as an Adjunct to Hemostasis in Subjects Undergoing Cardiovascular Surgery
The objective of this study is to assess the safety and effectiveness of Veriset™ Hemostatic Patch in cardiovascular procedures by comparing Veriset™ Hemostatic Patch to TachoSil® in subjects undergoing open cardiovascular…
- Trial name
- NCT01639833
- Testing
- Veriset Hemostatic Patch, TachoSil®
- Where
- 12 sites in Belgium, Germany and 1 more
- Volunteers
- 90 people
- Sponsor
- Medtronic - MITG
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
Acute Kidney Injury Following Cardiac Surgery
A Multi-center Study to Evaluate the Safety, Tolerability and Efficacy of TIN816 in Patients at Risk for Acute Kidney Injury Following Cardiac Surgery.
This was a randomized, multi-centric, placebo-controlled, participant and investigator-blinded study to evaluate the safety, tolerability and efficacy of TIN816 in adult patients at risk for acute kidney injury following cardiac…
- Trial name
- NCT05524051
- Testing
- TIN816
- Where
- 37 sites in United States, Argentina and 13 more
- Volunteers
- 102 people
- Sponsor
- Novartis Pharmaceuticals
Mitral Stenosis With Insufficiency, Functional Mitral Regurgitation
AVJ-514 Japan Trial
The objective of the study is to confirm the reproducibility of the evidence of safety and efficacy of AVJ-514 System technology in Japanese subjects who have been deemed difficult for mitral valve surgery by the local site heart…
- Conditions
- Mitral Stenosis With Insufficiency, Functional Mitral Regurgitation, Mitral Insufficiency, Mitral Valve Incompetence
- Trial name
- NCT02520310
- Testing
- AVJ-514
- Where
- 6 sites in Japan
- Volunteers
- 30 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Insufficiency, Aortic Valve Regurgitation
Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra
The purpose of this study is to further evaluate the long-term safety and effectiveness of the Biocor and Biocor Supra Valves.
- Conditions
- Aortic Valve Insufficiency, Aortic Valve Regurgitation, Aortic Valve Stenosis, Aortic Valve Incompetence
- Trial name
- NCT00636987
- Testing
- Biocor and Biocor Supra valves
- Where
- 17 sites in United States
- Volunteers
- 297 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
Medical Need of OAC Reversal
This is a retrospective, observational, claims cohort study to assess, for adult patients initiating an oral anticoagulant for NVAF
- Trial name
- NCT03254147
- Testing
- warfarin, dabigatran, Apixaban
- Where
- Japan
- Volunteers
- 53,969 people
- Sponsor
- Boehringer Ingelheim
Acute Coronary Syndrome (ACS)
Maintenance of Platelet Inhibition With Cangrelor
The purpose of this study is to demonstrate that patients receiving cangrelor infusion before coronary artery bypass grafting have an acceptable safety profile and can undergo surgery without excessive bleeding peri-operatively.
- Trial name
- Bridge (NCT00767507)
- Testing
- cangrelor
- Where
- United States
- Volunteers
- 221 people
- Sponsor
- The Medicines Company
Coronary Disease
Obtain Additional Information on Use of CorMatrix ECM (Extracellular Matrix)
The objective of the study is to actively gather additional information on the use of CorMatrix ECM for pericardial reconstruction.
- Trial name
- RECON (NCT02073331)
- Where
- 43 sites in United States
- Volunteers
- 1,420 people
- Sponsor
- Elutia Inc.