Clinical trials: Surgery, Cardiovascular
- Condition Surgery, Cardiovascular
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
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
Prevention of Venous Thromboembolism, Congenital Heart Disease
An Observational Study to Learn More About How Safe Rivaroxaban is And How Well it Works in Children With Congenital Heart Disease Who Had a Heart Surgery Called the Fontan Procedure
This is an observational study in which the data from children with congenital heart disease will be collected and studied. These children will include those who are prescribed rivaroxaban by their doctors after a heart surgery…
- Conditions
- Prevention of Venous Thromboembolism, Congenital Heart Disease, Fontan Procedure, Children
- Trial name
- NCT06193863
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Where
- Japan
- Volunteers
- 61 people
- Sponsor
- Bayer
Atrial Septal Defect, Ventricular Septal Defect
Intravenous L-Citrulline to Treat Children Undergoing Heart Bypass Surgery : Revised Protocol
This clinical trial will determine the safety and effectiveness of intravenous L-citrulline in children undergoing cardiopulmonary bypass during heart surgery.
- Conditions
- Atrial Septal Defect, Ventricular Septal Defect, Atrioventricular Septal Defect
- Trial name
- NCT01120964
- Testing
- Intravenous L-Citrulline
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Asklepion Pharmaceuticals, LLC
Carotid Artery Disease
CHOICE: Carotid Stenting For High Surgical-Risk Patients
The purposes of this study is to 1) Provide additional information that the commercially available Abbott Vascular Carotid Stent Systems and Embolic Protection Systems can be used successfully by a wide range of physicians under…
- Trial name
- NCT00406055
- Testing
- RX ACCULINK , RX ACCUNET , XACT , EMBOSHIELD and EMBOSHIELD Nav6
- Where
- United States
- Volunteers
- 18,855 people
- Sponsor
- Abbott Medical Devices
Cardiac Arrest, Sudden
AED Log Analysis of 19 Cases in Out-of-hospital Environment
The study performed to demonstrate a reasonable assurance of safety and effectiveness of the Heart Guardian HR-501 when used in an out-of-hospital environment.
- Trial name
- NCT03969797
- Testing
- RADIAQBIO Heart Guardian HR-501
- Where
- South Korea
- Volunteers
- 19 people
- Sponsor
- RadianQbio
Congenital Heart Disease
Autus Valve Continued Access Study (CAS)
Prospective, single-arm, multi-center, continued access study of the Autus Size-Adjustable Valve in pediatric patients aged 18 months to 16 years requiring surgical pulmonary valve replacement.
- Trial name
- NCT07466745
- Testing
- Pulmonary Valve Replacement Surgery
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Edwards Lifesciences
Carotid Artery Diseases, Stroke
Boston Scientific Embolic Protection, Inc. (EPI): A Carotid Stenting Trial for High-Risk Surgical Patients (BEACH)
The purpose of this study is to determine whether morbidity and mortality for high-risk surgical patients treated with the Carotid Wallstent in conjunction with the FilterWire EX and EZ System distal protection device will be…
- Conditions
- Carotid Artery Diseases, Stroke, Cerebral Arteriosclerosis
- Trial name
- BEACH (NCT00316108)
- Testing
- WALLSTENT® Endoprosthesis™
- Where
- 50 sites in United States
- Volunteers
- 747 people
- Sponsor
- Boston Scientific Corporation
Hemophilia A
Study Evaluating B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery
This study will examine the efficacy and safety of ReFacto AF in patients with severe and moderately severe hemophilia A undergoing elective major surgery when administered by either bolus injections (BI) or continuous infusion…
- Trial name
- NCT00243659
- Testing
- ReFacto AF
- Where
- 17 sites in United States, Australia and 6 more
- Volunteers
- 30 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Myocardial Ischemia, Heart Defects, Congenital
Spectroscopic Assessment of Myocardial Oxygenation Changes in Pediatric Heart Surgery
The goal of this observational study is to investigate the ability of the SpectroCor Tissue Oxygenation Monitor and its accessory SpectroCor Sensor to observe and monitor changes in cardiac oxygen availability in pediatric…
- Conditions
- Myocardial Ischemia, Heart Defects, Congenital, Reperfusion Injury, Myocardial
- Trial name
- NCT07785141
- Where
- Finland
- Volunteers
- 30 people
- Sponsor
- Spectrocor
Ventricular Septal Defect, Atrioventricular Septal Defect
A Study Evaluating the Efficacy and Safety of IV L-Citrulline for the Prevention of Clinical Sequelae of Acute Lung Injury Induced by Cardiopulmonary Bypass in Pediatric Patients Undergoing Surgery for Congenital Heart Defects
This is a randomized, double-blind, placebo controlled, multicenter study to compare the efficacy and safety of L-citrulline versus placebo in patients undergoing surgery for congenital heart defects.
- Conditions
- Ventricular Septal Defect, Atrioventricular Septal Defect, Primum Atrial Septal Defect
- Trial name
- NCT05253209
- Testing
- L-citrulline, Plasmalyte A
- Where
- 10 sites in United States
- Volunteers
- 64 people
- Sponsor
- Asklepion Pharmaceuticals, LLC
Mitral Valve (MV) Regurgitation
ACCESS-Europe A Two-Phase Observational Study of the MitraClip® System in Europe
The MitraClip System enables the European physicians an alternative therapeutic option for patients with mitral regurgitation (MR).
- Trial name
- ACCESS-EU (NCT01288976)
- Testing
- MitraClip, Medical Management, Mitral Valve Surgery
- Where
- Germany
- Volunteers
- 721 people
- Sponsor
- Abbott Medical Devices
Severe Aortic Stenosis
Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI).
The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients…
- Trial name
- SURTAVI (NCT01586910)
- Testing
- Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI), Surgical Aortic Valve Replacement (SAVR), Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 86 sites in United States, Canada and 7 more
- Volunteers
- 1,746 people
- Sponsor
- Medtronic Cardiovascular
Congenital Heart Diseases
Ulinastatin Injection in in Pediatric Patients Undergoing Open Heart Surgery
1. Explore the efficacy of Ulinastatin use in improving post-operative pulmonary insufficiency and safety in pediatric patients undergoing scheduled CPB open heart surgery to treat Complex Congenital Heart Disease 2.
- Trial name
- NCT02527811
- Testing
- Ulinastatin
- Where
- 5 sites in China
- Volunteers
- 450 people
- Sponsor
- Techpool Bio-Pharma Co., Ltd.
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
Cardiovascular Disease
Special Drug Use Investigation for ARIXTRA (Fondaparinux) Abdominal General Surgery
The purpose of this study is to collect and assess information on safety and efficacy of fondaparinux in patients undergoing general surgery of the lower limb at high risk of developing venous thromboembolism.
- Trial name
- NCT01390896
- Testing
- Fondaparinux Sodium
- Volunteers
- 329 people
- Sponsor
- GlaxoSmithKline
Cardiovascular Surgical Procedure
CardioRoot Post-Marketing Surveillance Registry
Post-marketing surveillance registry of the CardioRoot graft.
- Trial name
- CardioRoot (NCT01609270)
- Testing
- CardioRoot graft
- Where
- 6 sites in Czechia, France and 1 more
- Volunteers
- 52 people
- Sponsor
- Maquet Cardiovascular
Aortic Valve Stenosis
Post-Market Surveillance Registry to Monitor Performance and Safety of V8 Device
This registry is designed to monitor the real world clinical performance and safety of the V8 device used to perform balloon aortic valvuloplasty (BAV).
- Trial name
- TAB-R (NCT02099942)
- Testing
- V8 Balloon Aortic Valvuloplasty (BAV) Catheter
- Where
- 7 sites in United States
- Volunteers
- 103 people
- Sponsor
- InterValve, Inc.
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 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.
Antithrombin III Deficiency
Safety, Pharmacokinetics and Efficacy of an ATIII Concentrate
To assess the safety, pharmacokinetics and efficacy of a plasma-derived AT-III concentrate in the treatment of subjects with congenital AT-III deficiency.
- Trial name
- NCT00319228
- Testing
- Plasma-derived AT-III concentrate
- Volunteers
- 3 people
- Sponsor
- Instituto Grifols, S.A.