Clinical trials: Surgery, Cardiovascular
Left Ventricular Dysfunction
IMpella-Protected cArdiaC Surgery Trial (IMPACT)
The purpose of this Trial is to demonstrate the safety and effectiveness of the use of Impella 5.5 in high-risk cardiac surgery patients, with the overall aim to evaluate if using Impella 5.5 with SmartAssist (Impella 5.5)…
- Trial name
- IMPACT (NCT05529654)
- Testing
- Impella 5.5 with SmartAssist
- Where
- 20 sites in United States
- Volunteers
- 100 people
- Sponsor
- Abiomed Inc.
Coronary Heart Disease
Health Care Analysis on Myocardial Revascularization in Patients With Chronic Coronary Heart Disease (CHD)
Myocardial infarction and chronic coronary heart disease (cCHD) are the most frequent causes of death in Germany. Treatment options include widening of the narrowed / blocked coronary vessel via catheter and stent or bypass…
- Trial name
- REVASK (NCT04599361)
- Where
- Germany
- Volunteers
- 385 people
- Sponsor
- InGef - Institute for Applied Health Research Berlin GmbH
Thromboembolism
Hip Fracture Study of GSK576428 (Fondaparinux Sodium)
This study is requested by PMDA to confirm the efficacy and the safety for HFS.
- Trial name
- NCT00320424
- Testing
- Fondaparinux
- Volunteers
- 48 people
- Sponsor
- GlaxoSmithKline
Venous Thromboembolism
Dose-confirmatory Bridging Study in Total Knee Replacement
The objective of this dose-confirmatory bridging study is to investigate the safety and efficacy of rivaroxaban 5 to 10 mg once-daily (od) dosing in the prevention of venous thromboembolism (VTE) in Japanese patients undergoing…
- Trial name
- NCT01206972
- Testing
- Rivaroxaban (BAY59-7939), Enoxaparin
- Where
- 33 sites in Japan
- Volunteers
- 302 people
- Sponsor
- Bayer
Anesthesia, General
Evaluation of Volatile Induction and Maintenance Anesthesia (VIMA) With Sevorane in Adult Patients Requiring General Anesthesia for Surgery in Terms of Quality of Anesthesia and Its Influence on the Cardiovascular System in Common Clinical Practice
The main objective of this post-marketing observational study (PMOS) is to collect data of using general anesthesia in patients undergoing any surgery to create local recommendations.
- Trial name
- SEVOPROTECTION (NCT01282086)
- Where
- 10 sites in Ukraine
- Volunteers
- 1,365 people
- Sponsor
- Abbott (Ukraine)
Meningioma, Tumor, Brain
MiDura-Study (Neuro-Patch in Duraplasty)
The aim of this study is to collect systematically and proactively data regarding the performance of Neuro-Patch, like complications and handling, under daily clinical practice when used as intended by the manufacturer
- Conditions
- Meningioma, Tumor, Brain, Chiari Malformation, Vascular Malformation
- Trial name
- MiDura (NCT04189172)
- Where
- 4 sites in France, Germany
- Volunteers
- 328 people
- Sponsor
- Aesculap AG
Heart Failure
Observational Study of ICD and Pacemaker Sensing in the Presence of IMED-4 Operation
The purpose is to monitor far field sensing artifacts of CRM devices in the presence of the IMED-4
- Trial name
- NCT02191696
- Testing
- IMED-4 recording
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- Intersection Medical, Inc.
Cardiac Disease, Post Surgery Patients
Comparison of Cardiac Output Measured by Ultrasound Dilution Method and Pulmonary Artery Thermodilution Technique
Cardiac output (CO) is an important hemodynamic variable in the management of critically ill patients. The pulmonary artery catheter (PAC) requires invasive techniques with potential complications and there is increasing interest…
- Trial name
- NCT01616017
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- Transonic Systems Inc.
Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia
Spectroscopic Assessment of Tissue Oxygenation Changes During Vascular Surgery
This study is a single-center, observational study designed to collect tissue spectrometric data related to tissue oxygenation.
- Conditions
- Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia, Ischemia Vascular, Tissue Ischemia
- Trial name
- NCT07786623
- Volunteers
- 30 people
- Sponsor
- Spectrocor
Abdominal Vascular Surgery, Peripheral Vascular Surgery
A Retrospective, Observational, Multicenter, Study to Collect Clinical Safety and Performance Data on POLYMAILLE®C
Purpose of the study is to describe safety and performance of POLYMAILLE® C from a minimum of 200 subjects will be evaluated. A minimum of 100 subjects will be evaluated for each main location of surgery (abdominal and…
- Conditions
- Abdominal Vascular Surgery, Peripheral Vascular Surgery, Vascular Prothesis, Aneurysm Abdominal
- Trial name
- NCT05517876
- Testing
- Vascular abdominal or peripheral surgery
- Where
- France
- Volunteers
- 212 people
- Sponsor
- Perouse Medical
Knee Arthroplasty, Total
FactOr XIa inhibiTion for the pRevention of venOus Thromboembolism in Patients Undergoing Total Knee Arthroplasty
This study was to compare the study drug BAY1213790 to existing therapies, i.e. enoxaparin or apixaban, for the prevention of blood clotting and safety in patients undergoing total knee arthroplasty (TKA).
- Trial name
- FOXTROT (NCT03276143)
- Testing
- Enoxaparin, Apixaban, BAY1213790
- Where
- 54 sites in Bulgaria, Canada and 11 more
- Volunteers
- 813 people
- Sponsor
- Bayer
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.
Coronary Artery Disease
SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries
The SYNTAX trial is designed to determine the best treatment for patients with complex coronary disease (blocked or narrowed arteries in both the right and left sides of the heart) by randomizing patients to receive either…
- Trial name
- SYNTAX (NCT00114972)
- Testing
- Polymer-based Paclitaxel-Eluting TAXUS Express2-SR Stent, Coronary Artery Bypass Surgery
- Where
- 106 sites in United States, Austria and 16 more
- Volunteers
- 1,800 people
- Sponsor
- Boston Scientific Corporation
Coronary Arteriosclerosis, Atrial Fibrillation
A(f)MAZE-CABG Study
Concomitant AF ablation with HIFU in patients with persistent or long standing persistent AF undergoing CABG will be superior in restoring SR, compared with patients with persistent or long standing persistent AF undergoing CABG…
- Conditions
- Coronary Arteriosclerosis, Atrial Fibrillation, Coronary Artery Bypass Graft Surgery
- Trial name
- AFMAZE-CABG (NCT00735722)
- Testing
- HIFU AF Ablation
- Where
- 10 sites in Canada, Finland and 4 more
- Volunteers
- 188 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation, Coronary Artery Disease
Clinical and Economic Consequences of Left Atrial Bipolar Radiofrequency Ablation of Persistent and Permanent Atrial Fibrillation During Cardiac Surgery
The clinical effects of intra-operative radiofrequency ablation in patients with persistent or permanent atrial fibrillation and an indication for an implantation of a heart valve prosthesis or coronary bypass surgery are the…
- Trial name
- NCT00157807
- Testing
- bipolar radiofrequency ablation of persistent and permanent AF
- Where
- 5 sites in Germany
- Volunteers
- 24 people
- Sponsor
- Medtronic 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.
Cardiovascular Diseases
Medtronic SYMBIOSIS Post-Market Registry for Patients Undergoing Cardiac Surgery
The purpose of this observational, multi-center prospective, post-market registry is to confirm real-world device safety and performance, to ensure the continued acceptability of identified risks, and detect emerging risks.
- Trial name
- SYMBIOSIS (NCT04241328)
- Where
- 14 sites in Austria, Belgium and 6 more
- Volunteers
- 5,000 people
- Sponsor
- Medtronic Cardiac Surgery
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
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
Myocardial Infarction
the Effect of Danhong Injection on Microcirculation in the Treatment of Patients With STEMI After the PTCA Surgery.
This study focused on the effect of Danhong injection on microcirculation in the treatment of patients with STEMI(ST-elevation myocardical infarction) after the PTCA surgery.
- Trial name
- Danhong (NCT02158559)
- Testing
- Danhong Injection, Normal Saline
- Volunteers
- 180 people
- Sponsor
- Beijing Bozhiyin T&S Co., Ltd.