Clinical trials: Post-cardiac Surgery
Atrial Fibrillation, Postoperative
Amiodarone-Infused CardiaMend Patches for the Prevention of New-Onset POAF in Cardiac Surgery Subjects
The goal of this clinical trial is to is to test the safety of a new way to deliver a commonly used drug (amiodarone) used in heart surgery by placing a patch containing the drug directly on the heart instead of in an IV (vein).
- Trial name
- AMIOMEND (NCT06730828)
- Testing
- The intervention includes Amiodarone-Infused CardiaMend patches (70mg, 150mg and 300mg)
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Helios Cardio Inc.
Cardiac Disease, Myocardial Dysfunction
Temporary Epicardial Pace Wire With Integrated Sensor for Continuous Postoperative Monitoring of Myocardial Function
Transesophageal echocardiography is used to monitor cardiac wall motion at various time points during open-heart surgery. After surgery, the measurements are made at various time points by transthoracic echocardiography.
- Trial name
- NCT04886934
- Testing
- CS1 System
- Where
- Norway
- Volunteers
- 38 people
- Sponsor
- Cardiaccs AS
Heart Failure With Reduced Ejection Fraction
Respiratory Sinus Arrhythmia (RSA) Pacing Post-CABG Surgery in Patients With HFrEF
The goal of this clinical trial is to test a new type of pacemaker in heart failure patients following a heart bypass operation.
- Trial name
- RSA-PACE (NCT06359938)
- Testing
- Atrial pacing with respiratory sinus arrhythmia (RSA) variability, Monotonic right atrial overdrive pacing
- Where
- United Kingdom
- Volunteers
- 30 people
- Sponsor
- Ceryx Medical Ltd
Vascular Disease
ArterX Safety and Efficacy Study for Cardiac Indications
The study is designed to confirm the acute safety and performance of the ArterX® Surgical Sealant as a hemostatic agent. The study will collect data in support of publications and future product labeling revisions, to provide…
- Trial name
- NCT01957904
- Testing
- ArterX Surgical Sealant
- Where
- Germany
- Volunteers
- 44 people
- Sponsor
- Tenaxis Medical, Inc.
Neonatal Disease, Post-Surgical Complication
Cardiac Surgery Recovery in Infants Assessed Using Neoneur Feeding System
A prospective non-randomized longitudinal design of 30-40 infants from initiation of oral feeding until discharge to track feeding changes as a potential indicator of surgical recovery.
- Conditions
- Neonatal Disease, Post-Surgical Complication, Cardiac Disease
- Trial name
- NCT06569641
- Testing
- Neoneur Feeding System
- Volunteers
- 35 people
- Sponsor
- Neoneur LLC
Coronary Artery Disease
A Study of Hemopure® to Enhance Tissue Preservation During Cardiopulmonary Bypass Surgery
The purpose of this study is to determine if Hemopure® will enhance tissue preservation during Cardiopulmonary Bypass surgery.
- Trial name
- NCT00301535
- Testing
- HBOC-201 (hemoglobin glutamer-250 bovine)
- Where
- 3 sites in Greece, South Africa and 1 more
- Volunteers
- 60 people
- Sponsor
- Biopure Corporation
Cerebral Hemorrhage, Head Injury
Biomarkers Correlation With Volemia
The purpose of this study is to determine whether the Biomarkers (pro adrenomedullin (MR proADM), pro arginin vasopressin (CT proAVP), pro atrial natriuretic peptid (MR proANP), Pro Endothelin) changes at Day 2, Day 5 and Day 7…
- Conditions
- Cerebral Hemorrhage, Head Injury, Non Traumatic Post Surgery, Poly Trauma Patients Without Heart Failure
- Trial name
- ENVOL (NCT01858675)
- Testing
- Biomarkers, red blood cells and plasma assessment
- Where
- France
- Volunteers
- 66 people
- Sponsor
- ThermoFisher Scientific Brahms Biomarkers France
Hypertension, Pulmonary, Ventricular Dysfunction, Left
Confirmatory Study of IK-3001 in Japanese Subjects With Peri-/Post-op Pulmonary Hypertension Assoc. With Cardiac Surgery
Sixteen Japanese subjects (6 adults/10 children) with peri- and post-operative pulmonary hypertension associated with cardiac surgery will be evaluated at approx. 6 sites for safety and efficacy of IK-3001.
- Trial name
- NCT01959828
- Testing
- IK-3001
- Where
- 7 sites in Japan
- Volunteers
- 18 people
- Sponsor
- Mallinckrodt
Heart Diseases, ASD - Atrial Septal Defect
Abbott Structural Heart Device Registry
The Abbott Structural Heart (SH) Registry is being conducted to confirm the safety and performance of Abbott's SH devices in a post-market, real-world setting.
- Conditions
- Heart Diseases, ASD - Atrial Septal Defect, VSD - Muscular Ventricular Septal Defect, PFO - Patent Foramen Ovale
- Trial name
- SH-Registry (NCT06590467)
- Testing
- Amplatzer™ Occlusion Devices, Epic™ Surgical Tissue Heart Valve devices
- Where
- 36 sites in United States, Denmark and 8 more
- Volunteers
- 2,500 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.
Post Cardiac Surgery
Measure Cardiac Output Using Ultrasound Dilution in Mechanically Ventilated Children
The measurement of cardiac output (CO) and hemodynamic pressures are vital for proper management of severely hemodynamic compromised patients.
- Trial name
- NCT01662141
- Where
- Sweden
- Volunteers
- 33 people
- Sponsor
- Transonic Systems Inc.
Single Ventricle Heart Disease After Fontan Surgery
Pharmacokinetic/Pharmacodynamic Study of Udenafil in Adolescents
To determine the pharmacokinetic profile and safety of udenafil in adolescents with Fontan physiology and to assess the short-term pharmacodynamic effect of udenafil on pharmacodynamic measures of exercise capacity, ventricular…
- Trial name
- NCT02201342
- Testing
- Udenafil
- Where
- 6 sites in United States, Canada
- Volunteers
- 36 people
- Sponsor
- Mezzion Pharma Co. Ltd
Hypoplastic Left Heart Syndrome, Single Ventricle
Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial)
The purpose of this study is to evaluate the efficacy and safety of intracoronary injection of JRM-001 after reconstructive surgery in pediatric patients with functional single ventricle
- Trial name
- APOLLON (NCT02781922)
- Testing
- Autologous cardiac stem cells (JRM-001)
- Where
- 4 sites in Japan
- Volunteers
- 40 people
- Sponsor
- Metcela Inc.
Ventilator Induced Diaphragm Dysfunction
Randomized Study of TransAeris® System in Cardiac Surgery Patients at Risk of Prolonged Mechanical Ventilation
This study will be conducted as a randomized trial of the TransAeris system for the prevention and treatment of ventilator-induced diaphragm dysfunction (VIDD) in patients identified prior to surgery to be at greater risk of…
- Trial name
- ERAS (NCT04899856)
- Testing
- TransAeris
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Synapse Biomedical
Mitral Regurgitation, Tricuspid Regurgitation
Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study
ARB-PMCF is a multicenter, observational study of the safety and performance of Abbott annuloplasty devices used in surgical repair of mitral and tricuspid valve regurgitation.
- Conditions
- Mitral Regurgitation, Tricuspid Regurgitation, Valvular Heart Disease
- Trial name
- ARB-PMCF (NCT04761120)
- Testing
- Abbott SJM Rigid Saddle Ring, Abbott SJM Séguin Ring, Abbott SJM Tailor Ring
- Where
- 17 sites in United States, Estonia and 5 more
- Volunteers
- 550 people
- Sponsor
- Abbott Medical Devices
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.
Off Pump Coronary Artery Bypass Surgery
Getinge's Beating Heart Product Family Post-Market Clinical Follow-up (PMCF) Study
This observational study aims to collect data on the performance and safety of Getinge's Beating Heart products used during open-heart coronary artery bypass graft surgery.
- Trial name
- NCT07286890
- Testing
- Vacuum Stabilizer System, Vacuum Positioner System, Blower/Mister
- Where
- 7 sites in United States, Germany and 1 more
- Volunteers
- 200 people
- Sponsor
- Maquet Cardiovascular