Clinical trials: Surgery, Cardiac
Sternum Closure
STEELEX® Sternum Set + BONE WAX® + STEELEX® Electrode Set in Patients Undergoing Cardiac Surgery
The aim of the study is to assess the effectiveness and performance of using STEELEX® Sternum Set, BONE WAX® and STEELEX® Electrode Set in patients undergoing cardiac surgery.
- Trial name
- STEADY (NCT06065800)
- Testing
- STEELEX® Sternum Set
- Where
- Spain
- Volunteers
- 150 people
- Sponsor
- Aesculap AG
Heart Defects, Congenital, Hypertension, Pulmonary
Intravenous L-Citrulline to Treat Children Undergoing Heart Bypass Surgery
This clinical trial will determine the safety and effectiveness of intravenous L-citrulline in children undergoing cardiopulmonary bypass during heart surgery.
- Trial name
- NCT00335244
- Testing
- L-citrulline
- Where
- United States
- Volunteers
- 77 people
- Sponsor
- Asklepion Pharmaceuticals, LLC
Ischemia Reperfusion Injury, Cardiac Surgery Associated - Acute Kidney Injury
A Study to Evaluate the Efficacy and Safety of BX-001N in Preventing Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI) and Major Adverse Kidney Events (MAKE)
This is a Randomized, Single-blind, Multi-center, Placebo-controlled, Phase 2a clinical trial of BX-001N to prevent patients from Cardiac Surgery Associated Acute Kidney Injury (CSA-AKI) and subsequent Major Adverse Kidney Events…
- Trial name
- NCT07164833
- Testing
- BX-001N Experimental group 1, BX-001N Experimental group 2
- Where
- 8 sites in South Korea
- Volunteers
- 50 people
- Sponsor
- Bilix Co.,Ltd.
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.
Atrial Fibrillation
Concomitant Treatment of Permanent Atrial Fibrillation
RESTORE-SR study is a multi-center, prospective, nonrandomized study with case matched concurrent controls to evaluate the safety and efficacy of the AtriCure Bipolar System
- Trial name
- RESTORE SR (NCT00566787)
- Testing
- Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System
- Where
- 10 sites in United States
- Volunteers
- 39 people
- Sponsor
- AtriCure, Inc.
Heart; Dysfunction Postoperative, Cardiac Surgery
Clinical Assessment of Nonin 7600 Near Infrared Spectroscopy (NIRS) Tissue Oximetry During Cardiovascular Surgery
An observational study designed to evaluate the performance of a new Near Infrared Spectroscopy (NIRS) tissue oximeter device in the clinical setting, including a cerebral sensor and peripheral sensor.
- Trial name
- NCT01289470
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Nonin Medical, Inc
Atrial Fibrillation, Surgery
CellFX® nsPFA™ Cardiac Surgery System to Treat Atrial Fibrillation
This feasibility study will be conducted to demonstrate the initial safety and effectiveness of the CellFX® nsPFA™ Cardiac Clamp in performing a box lesion around the 4 pulmonary veins as an isolated procedure or as a part of a…
- Conditions
- Atrial Fibrillation, Surgery, Ablation of Atrial Fibrillation, Clamp Study
- Trial name
- NCT06355063
- Testing
- CellFX® nsPFA™ Cardiac Surgery System
- Where
- 6 sites in Austria, Netherlands and 1 more
- Volunteers
- 30 people
- Sponsor
- Pulse Biosciences, Inc.
Myocardial Ischemia
Safety & Efficacy of Adipose-Derived Regenerative Cells in the Treatment of Chronic Myocardial Ischemia (ATHENA II)
This is a prospective, randomized, placebo-controlled, double blind safety and efficacy clinical trial.
- Trial name
- ATHENA II (NCT02052427)
- Testing
- Celution System
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Cytori Therapeutics
Atrial Fibrillation
Safety and Efficacy Study of The Combined Ablation Procedure To Treat Longstanding Persistent Atrial Fibrillation
This is a multi-center, prospective open label, feasibility study evaluating the safety and efficacy of the combined ablation procedure for the treatment of longstanding persistent atrial fibrillation.
- Trial name
- CAPstopsLSPAF (NCT01103661)
- Testing
- Numeris®-AF Guided Coagulation System with VisiTrax®
- Where
- 4 sites in United States
- Volunteers
- 7 people
- Sponsor
- nContact Surgical Inc.
Heart Failure, Cardiovascular Disease
HeartMate 3™ LIS Study
The purpose of this study is to evaluate a less invasive implantation technique of the HeartMate 3 Left Ventricular Assist System (HM 3 LVAS) in 10 patients.
- Trial name
- HM 3 LIS (NCT02475460)
- Testing
- Less Invasive Surgery (LIS), HeartMate 3™
- Where
- 3 sites in Czechia, Germany
- Volunteers
- 13 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease, Cardiac Valve Insufficiency
Study on the Clinical Performance of Steelex® Sternum Set for Sternal Closure
The study is designed as a retrospective, international, multi-center cohort study to evaluate Steelex® Sternum Set for sternum closure.
- Conditions
- Coronary Artery Disease, Cardiac Valve Insufficiency, Aortic Valve Stenosis
- Trial name
- STERCCAS (NCT05439395)
- Testing
- Sternum Closure after Cardiac Surgery
- Where
- 2 sites in Germany, Spain
- Volunteers
- 229 people
- Sponsor
- Aesculap AG
Coronary Disease, Heart Valve Diseases
CTI-01 (Ethyl Pyruvate) Safety and Complication Prevention in Cardiac Surgery Patients on Cardiopulmonary Bypass (CPB)
Over 500,000 patients undergo cardiac surgery with CPB in the United States annually. Although mortality rates have decreased with advances in perioperative care, many patients are affected by postoperative organ dysfunction.
- Trial name
- NCT00107666
- Testing
- CTI-01 (ethyl pyruvate)
- Where
- 17 sites in United States
- Volunteers
- 150 people
- Sponsor
- Critical Therapeutics
Congenital Heart Malformations
Study of Cardioplegia in Cardiac Surgery Due to Congenital Heart Malformation in Children
The objective of this investigation is to compare the safety and cardioprotective effects of Custodiol and Custodiol-N in children undergoing cardiac surgery with cardiopulmonary bypass (CPB) due to congenital heart malformation.
- Trial name
- NCT07381530
- Testing
- heart will be treated with Custodiol-N, heart will be treated with Custodiol
- Where
- 3 sites in Germany
- Volunteers
- 100 people
- Sponsor
- Dr. F. Köhler Chemie GmbH
Aortic Valve Stenosis, Heart Valve Diseases
RHEIA (Randomized researcH in womEn All Comers With Aortic Stenosis)
Purpose of this prospective, randomized, controlled, multi-center study is to evaluate the safety and efficacy of Transcatheter Aortic Valve Implantation (TAVI) as compared to surgical aortic valve replacement (SAVR) in female…
- Trial name
- RHEIA (NCT04160130)
- Testing
- Transcatheter aortic valve replacement
- Where
- 48 sites in Austria, Belgium and 10 more
- Volunteers
- 432 people
- Sponsor
- Optimapharm
HLHS
Lomecel-B Delivered During Stage II Surgery for Hypoplastic Left Heart Syndrome (ELPIS)
This study is designed to assess the safety, tolerability, and efficacy of Lomecel-B as an adjunct therapy to the standard stage II (BDCPA) surgical intervention for HLHS. Lomecel-B will be delivered via intramyocardial injections
- Trial name
- ELPIS (NCT03525418)
- Testing
- Longeveron Mesenchymal Stem Cells
- Where
- 5 sites in United States
- Volunteers
- 10 people
- Sponsor
- Longeveron Inc.
Rigid Plate Fixation, Median Sternotomy
A Prospective, Single Center, Observational Study to Assess the Rapid Recovery After Cardiac Surgery Using SternaLock XP
The primary objective of this study is to evaluate the post-operative rapid recovery in patients treated with SternaLock XP for rigid sternal fixation with sternal precautions less restrictive than standard of care.
- Trial name
- RACE XP (NCT05578651)
- Testing
- SternaLock XP
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Zimmer Biomet
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.
Acute Kidney Injury
Study to Prevent Acute Kidney Injury After Cardiac Surgery Involving Cardiopulmonary Bypass
The objective of the study is to assess the safety and efficacy of ANG-3777 in preventing AKI compared to placebo when administered to patients at risk for developing acute kidney injury (AKI) following cardiac surgical…
- Trial name
- NCT02771509
- Testing
- ANG-3777
- Where
- 40 sites in United States, Brazil and 2 more
- Volunteers
- 275 people
- Sponsor
- Angion Biomedica Corp
Coronary Artery Bypass Grafting (CABG) Surgery
A Study Testing the Elana Device for Multi-Artery Heart Bypass Surgery
The purpose of the trial is to evaluate the feasibility and safety of multiple Elana Anastomotic Systems to anastomose multiple arterial grafts during coronary artery bypass grafting (CABG).
- Trial name
- MULTI-CAB (NCT07005843)
- Testing
- The Elana Anastomotic System
- Where
- Netherlands
- Volunteers
- 25 people
- Sponsor
- AMT Medical BV
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