Clinical trials: Cardiac Diseases Requiring Surgery
Longstanding Persistent Atrial Fibrillation
Evaluation of the Cardioblate CryoFlex Surgical Ablation System in Longstanding Persistent Atrial Fibrillation
Studies have shown that taking drugs to stay out of AF has limited success. This research is designed to study heart rhythm after surgical therapy, namely by measuring if there are benefits to having surgery to treat Atrial…
- Trial name
- CRYO-AF (NCT01558635)
- Testing
- Cardioblate CryoFlex Surgical Ablation, Mitral Valve surgery, Medtronic Reveal XT Insertable Cardiac Monitor
- Where
- 4 sites in Germany, Israel and 2 more
- Volunteers
- 17 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Acquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass
Use of Activated Recombinant Human Factor VII in Cardiac Surgery
This trial is conducted in Africa, Asia, Europe, South America and the United States of America (USA). The trial is planned to investigate the safety and efficacy of NovoSeven® in the management of post-operative bleeding in…
- Trial name
- NCT00154427
- Testing
- activated recombinant human factor VII
- Where
- 63 sites in United States, Argentina and 12 more
- Volunteers
- 172 people
- Sponsor
- Novo Nordisk A/S
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
Acquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass
Multi-national Study Investigating the Effect and Safety of rFXIII on Transfusion Needs in Patients Undergoing Heart Surgery
This trial is conducted in Canada, Asia, Europe and USA. The aim of this clinical trial is to investigate the effect and safety of rFXIII on transfusion needs in patients undergoing heart surgery.
- Trial name
- NCT00914589
- Testing
- catridecacog
- Where
- 32 sites in United States, Canada and 8 more
- Volunteers
- 479 people
- Sponsor
- Novo Nordisk A/S
Coronary Artery Bypass Surgery, Coronary Heart Disease
An Efficacy and Safety Study for Nesiritide in Heart Failure Patients With Reduced Kidney Function Undergoing Coronary Artery Bypass Graft Surgery Requiring Cardiopulmonary Bypass (CPB Pump or Heart Lung Machine)
The purpose of this study is to assess whether nesiritide compared to placebo when given with standard of care therapies, helps preserve kidney function in heart failure (HF) patients undergoing heart bypass graft surgery that…
- Conditions
- Coronary Artery Bypass Surgery, Coronary Heart Disease, Coronary Artery Bypass Grafting, Cardiopulmonary Bypass
- Trial name
- NCT00530361
- Testing
- Nesiritide
- Sponsor
- Scios, Inc.
Aortic Stenosis
PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis
To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement.
- Trial name
- P3 (NCT02675114)
- Testing
- SAVR, SAPIEN 3 THV
- Where
- 77 sites in United States, Australia and 3 more
- Volunteers
- 1,000 people
- Sponsor
- Edwards Lifesciences
Congestive Heart Failure, Coronary Artery Disease
Autologous Cultured Myoblasts (BioWhittaker) Transplanted Via Myocardial Injection
MyoCell™ implantation by epicardial injection during CABG surgery has the potential to add a new dimension to the management of post-infarct deterioration of cardiac function.
- Conditions
- Congestive Heart Failure, Coronary Artery Disease, Myocardial Infarction
- Trial name
- NCT00050765
- Testing
- MyoCell™ Autologous Myoblasts
- Where
- 5 sites in United States
- Volunteers
- 15 people
- Sponsor
- Bioheart, Inc.
Atrial Fibrillation
SOLAR & ATRILAZE Atrial Fibrillation Trial
The purpose of study is to conduct a pivotal evaluation of the EndoPhotonix™ SOLAR™ System and ATRILAZE™ System in order to obtain a labeling claim on the devices for the treatment of atrial fibrillation.
- Trial name
- SAAF-T (NCT00734058)
- Testing
- Laser MAZE by Ablation of Cardiac Tissue
- Volunteers
- 90 people
- Sponsor
- EndoPhotonix, Inc.
Aortic Valve Disease, Mitral Valve Disease, Prosthetic Heart Valve Dysfunction, Valvular Heart Disease Requiring Surgical Aortic or Mitral Valve Replacement
Safety and Performance of Dafodil Heart Valves in Real-World Aortic and Mitral Valve Replacement
This study, called the EuroDafodil Registry, is being conducted to understand how safe and effective the Dafodil™ and Dafodil Neo™ Pericardial Bioprosthetic heart valves are when used in routine medical practice.
- Trial name
- NCT07379112
- Testing
- Dafodil™ / Dafodil Neo™ Pericardial Bioprosthetic Heart Valve
- Volunteers
- 500 people
- Sponsor
- Meril Life Sciences Pvt. Ltd.
Acquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass
Safety of rFXIII in Patients Following First Time Myocardial Revascularization Requiring Cardiopulmonary Bypass
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to evaluate the safety of escalating single doses of rFXIII (recombinant factor XIII, catridecacog) administered following first…
- Trial name
- NCT02239146
- Testing
- catridecacog
- Where
- 24 sites in United States, Canada and 3 more
- Volunteers
- 43 people
- Sponsor
- Novo Nordisk A/S
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.
Sepsis, Post Cardiac Surgery Low Output Syndrome Requiring Inotropic/Vasopressor Therapy
Comparison of Central Venous Oxygen Saturation Measurements by Non-invasive Mespere Venous Oximeter and Central Venous Catheter
The intent of this study is to validate the venous blood oxygenation measurements of the Mespere VA Oximeter compared to the saturations measured by venous blood sampling through an inserted central vein catheter, which is…
- Conditions
- Sepsis, Post Cardiac Surgery Low Output Syndrome Requiring Inotropic/Vasopressor Therapy, Cardiogenic Shock Post Myocardial Infarction, Hypoxemic Respiratory Failure.
- Trial name
- NCT01788956
- Testing
- Mespere Venous Oximeter, Co-Oximeter
- Where
- Canada
- Volunteers
- 40 people
- Sponsor
- Mespere Lifesciences Inc.
Acquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass
Safety of Recombinant Factor XIII (rFXIII) in Healthy Japanese Volunteers
This trial is conducted in Japan. The aim of this trial is to investigate the safety profile of recombinant factor XIII (rFXIII) assessed by the occurrence of adverse events in healthy Japanese subjects.
- Conditions
- Acquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass, Healthy
- Trial name
- NCT01153997
- Testing
- catridecacog
- Where
- Japan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Cerebral Autoregulation Impairment, Postoperative Cognitive Dysfunction
BrainProtect-guided, Real-time Cerebral Autoregulation Monitoring and Protection of Brain During Cardiac Surgery With Cardiopulmonary Bypass Requiring Heart-lung Machine
The purpose of this clinical investigation is to evaluate the clinical performance, safety, and clinical benefit of the BrainProtect System in reducing early postoperative neurological complications in adult participants…
- Conditions
- Cerebral Autoregulation Impairment, Postoperative Cognitive Dysfunction, Postoperative Delirium
- Trial name
- BrainProtect (NCT07872982)
- Testing
- BrainProtect System, Standard perioperative management
- Where
- 4 sites in United States, Austria and 2 more
- Volunteers
- 304 people
- Sponsor
- Scienceforbrain, UAB
Acute Myocardial Infarction (AMI), Asystole
SPIKE FLOW Endocardial Lead Safety and Performance Study
The objective of this study is to assess the safety and performance of the SPIKE FLOW endocardial lead. Primary objectives are to assess: safety in terms of freedom from Serious Adverse Events(SADEs); performance in terms of Mean…
- Conditions
- Acute Myocardial Infarction (AMI), Asystole, Bradycardia, AV Block
- Trial name
- SPIKE FLOW (NCT07820072)
- Testing
- Lead insertion, lead removal
- Where
- 3 sites in Italy
- Volunteers
- 131 people
- Sponsor
- FIAB SpA
Acquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass
Activated Recombinant Human Factor VII Following Cardiac Bypass Surgery for Paediatric Congenital Heart Disease
This trial is conducted in Oceania. The aim of this trial is to investigate the efficacy of activated recombinant human factor VII and standard treatment compared with standard haemostatic replacement therapy in cardiopulmonary…
- Trial name
- NCT01562574
- Testing
- activated recombinant human factor VII
- Where
- Australia
- Volunteers
- 82 people
- Sponsor
- Novo Nordisk A/S
Respiratory Failure, Respiratory Arrest
Postoperative Respiratory Abnormalities
The study aims to determine how historical cases of respiratory abnormalities are documented by clinicians in the electronic health records (EHR) of Memorial Hermann Healthcare System (MHHS) inpatient facilities.
- Conditions
- Respiratory Failure, Respiratory Arrest, Respiratory Distress Syndrome, Acute Respiratory Failure
- Trial name
- AI-ARF (NCT04079829)
- Testing
- Observational retrospective cohort to describe data validity; and Data reliability; and Completeness of the data
- Where
- United States
- Volunteers
- 50,000 people, healthy volunteers welcome
- Sponsor
- Efficacy Care R&D Ltd
Coronary Artery Bypass Grafting, Mitral Valve Surgery
Levosimendan in Patients With Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery On Cardiopulmonary Bypass
A study to evaluate levosimendan compared with placebo in reducing the composite event rate of all-cause death, perioperative MI, need for new dialysis, or use of mechanical assist (IABP, LVAD or ECMO) in subjects with reduced…
- Conditions
- Coronary Artery Bypass Grafting, Mitral Valve Surgery, Low Cardiac Output Syndrome
- Trial name
- LEVO-CTS (NCT02025621)
- Testing
- Levosimendan
- Where
- 60 sites in United States, Canada
- Volunteers
- 882 people
- Sponsor
- Tenax Therapeutics, Inc.