Clinical trials: Surgery, Cardiovascular
Coronary Artery Diseases, Multivessel Coronary Artery Disease
SYNTAX III REVOLUTION Trial: A Randomized Study Investigating the Use of CT Scan and Angiography of the Heart to Help the Doctors Decide Which Method is the Best to Improve Blood Supply to the Heart in Patients With Complex Coronary Artery Disease
The SYNTAX III Revolution trial is a randomized diagnostic research study that investigates the use of CT scan and angiogram of the heart to help doctors decide which method is the best to improve blood supply to the heart in…
- Conditions
- Coronary Artery Diseases, Multivessel Coronary Artery Disease, Heart Diseases, Cardiovascular Diseases
- Trial name
- SYNTAX III (NCT02813473)
- Testing
- Coronary Angiography, Computed Tomography (CT) scan
- Where
- 6 sites in Belgium, France and 3 more
- Volunteers
- 223 people
- Sponsor
- ECRI bv
Thromboembolism
Melagatran/Ximelagatran Versus Enoxaparin for the Prevention of Venous Thromboembolic Events
This study is being carried out to study the efficacy and safety of treatment with melagatran injection followed by ximelagatran tablets in preventing blood clots, compared with enoxaparin for a period of 5-6 weeks.
- Trial name
- EXTEND (NCT00206089)
- Testing
- EXANTA
- Where
- 125 sites in Austria, Belgium and 14 more
- Volunteers
- 3,300 people
- Sponsor
- AstraZeneca
Aortic Valve Disease, Aortic Stenosis
EDWARDS INTUITY Valve System CADENCE Study
The study purpose is to compare the EDWARDS INTUITY valve system with commercially available stented aortic bioprostheses, in patients requiring aortic valve replacement surgery with coronary artery bypass.
- Trial name
- CADENCE (NCT02688153)
- Testing
- EDWARDS INTUITY, Stented aortic bioprostheses
- Where
- France
- Volunteers
- 120 people
- Sponsor
- Edwards Lifesciences
Cardiac Surgical Procedures, Coronary Artery Disease
Clinical Outcomes in Patients Treated With SternaLock Blu
The primary objective of this study is to evaluate the rate of deep sternal wound infection at 30 days post-operative following a full median sternotomy in patients treated with SternaLock Blu for rigid sternal fixation.
- Conditions
- Cardiac Surgical Procedures, Coronary Artery Disease, Heart Valve Diseases
- Trial name
- SECURE (NCT03709693)
- Testing
- SternaLock Blu
- Where
- 4 sites in United States
- Volunteers
- 156 people, healthy volunteers welcome
- Sponsor
- Zimmer Biomet
Valve Disease, Heart
Medtronic Cardiac Surgery PMCF Registry
This registry is being conducted to support ongoing post-market surveillance activities.
- Trial name
- NCT04073420
- Testing
- Surgical Heart Valve Repair Products, Surgical Heart Valve Replacement Products
- Where
- 26 sites in United States, Austria and 8 more
- Volunteers
- 2,700 people
- Sponsor
- Medtronic Cardiac Surgery
Deep Vein Thrombosis
Geko Neuromuscular Stimulator vs Thromboembolism Deterrent Stockings (TEDS): DVT Prevention Study
This study hypothesises that the geko™ device is more efficient than TEDS in preventing the formation of symptomatic/asymptomatic Deep Vein Thrombosis (DVTs), post-surgery.
- Trial name
- NCT01935414
- Testing
- geko™ post-surgery for 48hrs then 4hrs/day until discharge., TEDS post-surgery for 48hrs then 4hrs/day until discharge.
- Where
- United Kingdom
- Volunteers
- 72 people
- Sponsor
- Firstkind Ltd
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
Pulmonary Hypertension
A Study to Evaluate the Efficacy, Safety and Tolerability of PDNO Infusion in Patients With Pulmonary Hypertension After Cardiopulmonary Bypass Surgery
This is an open-label, multicenter study evaluating the dose, effect, safety and tolerability of intravenous PDNO infusion given to patients undergoing cardiopulmonary bypass (CPB) surgery with post-operative acute pulmonary…
- Trial name
- NCT05699486
- Testing
- PDNO
- Where
- 2 sites in Sweden
- Volunteers
- 12 people
- Sponsor
- Attgeno AB
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 Artery Disease
The Use of Aging Biomarkers to Predict Adverse Outcomes After Cardiac Surgery
Cardiac surgery associated acute kidney injury (CSA-AKI) has been recognized as the second most common cause of hospital acquired AKI.
- Trial name
- NCT02496234
- Where
- United States
- Volunteers
- 186 people
- Sponsor
- Sapere Bio
Dilated Cardiomyopathy
Safety and Feasibility of Algisyl-LVR™ as a Method of Left Ventricular Restoration in Patients With DCM Undergoing Open-heart Surgery
This is a pilot study to evaluate the feasibility and safety of the Algisyl-LVR™ device. The purpose of this study is to investigate Algisyl-LVR™ employed as a method of left ventricular restoration in patients with dilated…
- Trial name
- NCT00847964
- Testing
- Algisyl-LVR
- Where
- 3 sites in Germany, Poland
- Volunteers
- 11 people
- Sponsor
- LoneStar Heart, Inc.
Diabetic Foot Ulcer, Pressure Injury
A Dual-center Study Evaluating Clinical Acceptance of a NPWT Wound Care System
The purpose of this study is to determine if use of the Medela Invia Motion NPWT system supports acceptable progress towards the goal of therapy when treating patients with a variety of wound types during the evaluation period.
- Conditions
- Diabetic Foot Ulcer, Pressure Injury, Pressure Ulcer, Surgical Wound
- Trial name
- NCT04593693
- Testing
- Invia Motion Endure NPWT system
- Where
- 2 sites in United States
- Volunteers
- 25 people
- Sponsor
- Medela AG
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
Peripheral Arterial Disease (PAD)
An Observational Study to Learn More About the Safety of Rivaroxaban in Participants With Peripheral Arterial Disease Who Had Surgery to Improve Blood Flow to Their Legs
This is an observational study in which data already collected from people with peripheral arterial diseases (PAD) who had a surgery to improve blood flow to their legs are studied.
- Trial name
- NCT07142655
- Where
- Japan
- Volunteers
- 1,500 people
- Sponsor
- Bayer
Aortic Valve Stenosis
Transapical Implantation of the Medtronic Engager Transcatheter Aortic Valve Implantation System - The Engager European Pivotal Trial
The purpose of the study is to evaluate the safety and clinical performance of the Engager Transcatheter Aortic Valve Implantation System in patients with severe aortic valve stenosis who are at high risk for surgical valve…
- Trial name
- NCT01348438
- Testing
- Medtronic Engager Transcatheter Aortic Valve Implantation System
- Where
- 9 sites in Belgium, Germany and 2 more
- Volunteers
- 125 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Carotid Artery Stenosis
GORE® Embolic Filter in Carotid Stenting for High Risk Surgical Subjects (EMBOLDEN)
Compare the 30-day safety and efficacy of the GORE® Embolic Filter used in conjunction with FDA-approved carotid stents to a performance goal obtained from carotid stent studies utilizing distal embolic protection.
- Trial name
- EMBOLDEN (NCT00766493)
- Testing
- GORE® Embolic Filter
- Volunteers
- 250 people
- Sponsor
- W.L.Gore & Associates
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
Thrombosis, Venous
Total Hip Replacement Study Of GSK576428 (Fondaparinux Sodium)
This study is requested by PMDA to confirm the optimal dose for THR (total hip replacement).
- Trial name
- NCT00320398
- Testing
- Fondaparinux
- Volunteers
- 114 people
- Sponsor
- GlaxoSmithKline
Arthroplasty, Replacement, Knee, Thromboembolism
Dabigatran Etexilate vs Enoxaparin in Prevention of Venous Thromboembolism (VTE) Post Total Knee Replacement
To determine the comparative efficacy and safety of two different doses (75mg day 1 followed by 150 mg day 2-completion, and 110 mg day 1 followed by 220 mg day 2-completion) of dabigatran administered orally (capsules), compared…
- Trial name
- NCT00152971
- Testing
- Dabigatran Dose 1 - day 2 to completion, Dabigatran Dose 1 - day 1, Dabigatran Dose 2 - day 2 to completion
- Where
- 94 sites in United States, Canada and 2 more
- Volunteers
- 2,615 people
- Sponsor
- Boehringer Ingelheim
Cardiac Disease, Healing Surgical Wounds
TYRX™ Pocket Health Study
Medtronic, Inc. is sponsoring the TYRX™ Pocket Health Study to evaluate the histological and morphometric parameters of the device capsule in participants who underwent a cardiovascular implantable electronic device (CIED)…
- Trial name
- NCT05356546
- Testing
- Study-required procedures include: tissue collection from device capsule, questionnaire collection, and photo collection
- Where
- 9 sites in United States, Canada and 2 more
- Volunteers
- 36 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure