Clinical trials: Aortic Valvular Surgery
Pericardial Effusion, Late Cardiac Tamponade
Evaluation of Different Strategies of Pericardial Drainage After Aortic Valvular Surgery
The incidence of pericardial effusion and late cardiac tamponade after aortic and valvular surgery is higher than after other cardiac surgical procedures.
- Conditions
- Pericardial Effusion, Late Cardiac Tamponade, Surgical Reintervention
- Trial name
- Blake (NCT00684125)
- Testing
- Blake Drains (Blake drain, Ethicon USA), Standard mediastinal drainage
- Where
- Canada
- Volunteers
- 150 people
- Sponsor
- Montreal Heart Institute
CABG, Aortic Dissection
CLEAR Trial: CA330 Cytokine Adsorption Column for Anticoagulant/Antiplatelet Patients in Non-Elective CPB Surgery.
The goal of this clinical trial is to evaluate whether the CA330 cytokine adsorption column can reduce perioperative severe bleeding adverse events in patients receiving anticoagulant and/or antiplatelet therapy who undergo…
- Conditions
- CABG, Aortic Dissection, Valvular Heart Diseases
- Trial name
- CLEAR (NCT07284199)
- Testing
- CA330 Cytokine Adsorption Column
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Beijing Anzhen Hospital
Coronary Artery Disease, Valvular Heart Disease
Sugammadex Titration in Cardiac Surgery Patients
Sugammadex is frequently used to reverse the effects of neuromuscular blocking drugs. The recommended doses are 2 mg/kg or 4 mg/kg depending upon the depth of neuromuscular blockade.
- Conditions
- Coronary Artery Disease, Valvular Heart Disease, Aorta Disease, Heart Failure
- Trial name
- NCT05246397
- Testing
- Sugammadex administration
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- University of Washington
Paravalvular Aortic Regurgitation
PARADIGM: Amplatzer Valvular Plug for PVL Closure
The Paradigm study is a prospective, multicenter, single arm study to demonstrate the safety and effectiveness of the Amplatzer Valvular Plug III (AVP III) as a treatment for clinically significant PVLs following surgical implant…
- Trial name
- PARADIGM (NCT04489823)
- Testing
- AVP III
- Where
- 24 sites in United States, Canada and 5 more
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
Patients With Elective Aortic Valve Replacement
Remote Ischemic Preconditioning Induces Myocardial RISK Signaling Pathway in Patients Undergoing Valvular Heart Surgery
The aim of this study is to investigate whether RIPC protects the heart against ischemia reperfusion injury on the concentrically hypertrophied myocardium
- Trial name
- NCT01946087
- Testing
- Remote ischemic preconditioning at left upper arm, Control group
- Where
- South Korea
- Volunteers
- 79 people
- Sponsor
- Yonsei University
Valvular Heart Disease, Aortic Disease
Effect of Anesthetics on CD39 and CD73 After Open-heart Surgery
CD39 and CD73 was known protein expressed on surface of Th1 and Th17 cell and modulate immune related reaction. Cardiopulmonary bypass (CPB) can induce inflammatory reaction during cardiac surgery, and induce immunosuppression.
- Trial name
- NCT02136979
- Testing
- Propofol, Sevoflurane
- Where
- South Korea
- Volunteers
- 2 people
- Sponsor
- Konkuk University Medical Center
Heart Disease, Aging
Prevalence and Post-surgical Outcomes of CARdiac Wild-type TransthyrEtin amyloidoSIs in Elderly Patients With Aortic steNosis Referred for Valvular Replacement.
Background: The prevalence of both senile cardiac amyloidosis (CA) and aortic stenosis (AS) markedly increases with age. Aortic stenosis increases left ventricular pressure overload.
- Conditions
- Heart Disease, Aging, Amyloidosis, Aortic Valve Stenosis
- Trial name
- AMYLOCARTESIAN (NCT02260466)
- Testing
- a basal LV septum biopsy
- Where
- 5 sites in France
- Volunteers
- 186 people
- Sponsor
- French Cardiology Society
Rheumatic Heart Disease With Valvulitis
Minimal Invasive Approaches For Aortic Valvular and Subvalvular Surgeries
To compare intraoperative and immediate postoperative outcomes of mini-sternotomy versus mini-thoracotomy as less invasive techniques in patients with isolated aortic valvular and subvalvular disease requiring surgery according…
- Trial name
- NCT06696560
- Testing
- Minimal Invasive Approaches in Aortic surgeries.
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Yahia Abd almonem Sayed
Coronary Artery Disease, Valvular Heart Disease
Prehabilitation for Patients Undergoing Elective Cardiac Surgery
The objective of this clinical trial is to develop a novel rehabilitation model that, through the PRECICA program, will help to reduce perioperative and postoperative complications in the care process prior to planned cardiac…
- Conditions
- Coronary Artery Disease, Valvular Heart Disease, Chronic Thromboembolic Pulmonary Hypertension, Aortic Diseases
- Trial name
- PRECICA (NCT07704086)
- Testing
- Physical exercise, Educational program and respiration physiotherapy
- Where
- 2 sites in Spain
- Volunteers
- 86 people
- Sponsor
- Hospital Universitario 12 de Octubre
Bicuspid Aortic Valve, Aortic Valve Stenosis
Progression of Ascending Aorta Diameters in Bicuspid Aortic Valve After Transcatheter or Surgical Replacement.
The goal of this prospective, non-randomized, single-center, observational study is to assess whether there is a progressive dilation of ascending aorta after surgical or transcatheter aortic valve replacement (TAVR) in patients…
- Conditions
- Bicuspid Aortic Valve, Aortic Valve Stenosis, Aortic Aneurysm, Heart Diseases
- Trial name
- ARDITAV (NCT05708118)
- Testing
- Echocardiographic assessment., Computed-tomography assessment
- Where
- Italy
- Volunteers
- 150 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Primary Valvular Heart Disease With Comorbid Coronary Artery Disease, Planned to Undergo Elective On-pump Valve Surgery Due to Primary Mitral and/or Aortic Valvular Heart Disease
Quantitative Flow Ratio (QFR) Guided Coronary Artery Bypass Grafting for Patients Undergoing Primary Valve Surgery With Concomitant Coronary Artery Disease
This is a multicenter, prospective, randomized, blinded, controlled clinical study in patients with planned primary valvular surgery and comorbid coronary artery lesions with diameter stenosis of ≥ 50%, to compare the…
- Trial name
- FAVOR IV-QVAS (NCT03977129)
- Testing
- QFR-guided strategy, CAG-guided strategy
- Where
- 12 sites in China
- Volunteers
- 792 people
- Sponsor
- Ruijin Hospital
Intensive Care Unit, Coronary Artery Bypass Grafting (CABG)
Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients
The MODIFY CSX study is a prospective, randomized, placebo-controlled trial conducted in heart centers in Germany and Italy. A total of 550 high-risk cardiac surgery patients will receive either 0.20 g fish oil/kg body weight…
- Conditions
- Intensive Care Unit, Coronary Artery Bypass Grafting (CABG), High Risk Patients, Cardiopulmonary Bypass
- Trial name
- MODIFY CSX (NCT06279793)
- Testing
- Fish Oil, Intravenous 0.9% Sodium Chloride
- Where
- 10 sites in Germany
- Volunteers
- 550 people
- Sponsor
- GCP-Service International West GmbH
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.
Aortic Aneurysm and Dissection, Coronary Artery Disease (CAD)
Effects of Myofascial Release on Cardiac Patients After Median Sternotomy
After deciding to join this study and signing the informed consent form, participants will undergo the following interventions: All participants will receive a preoperative assessment (Tp) before surgery.
- Conditions
- Aortic Aneurysm and Dissection, Coronary Artery Disease (CAD), Valve Heart Disease
- Trial name
- NCT07649330
- Testing
- myofascial release+Routine Physical Therapy, Routine Physical therapy
- Where
- Taiwan
- Volunteers
- 50 people
- Sponsor
- Siou-Pin Huang
Valvular Heart Disease, Aortic Arch Aneurysm
The Effects of Intermittent Hypoxic-hyperoxic Preconditioning for Patients Undergoing Cardiopulmonary Bypass.
The aim of the study is to evaluate the effects of intermittent hypoxic-hyperoxic training (IHHT) to protect myocardium against perioperative myocardial injury during cardiac surgery using cardiopulmonary bypass.
- Conditions
- Valvular Heart Disease, Aortic Arch Aneurysm, Surgery
- Trial name
- NCT04833283
- Testing
- ReOxy Cardio device, intermittent hypoxic-hyperoxic training ( IHHT), ReOxy Cardio device
- Where
- Russia
- Volunteers
- 115 people
- Sponsor
- I.M. Sechenov First Moscow State Medical University
Valvular Heart Disease
Comparing Measurements of the Aortic Valve Taken During Surgery With Those Obtained Before Surgery Using Computed Tomography Scans, in Patients Undergoing Surgical Aortic Valve Replacement
This study aims to understand why there may be differences between the measurements of the aortic valve taken before and during surgery.
- Trial name
- SAVR-CT-AVA (NCT07125469)
- Testing
- The measurements taken from the CT scan will be used to determine the appropriate size for two types of theoretical Transcatheter Aortic Valve Replacement (TAVR) prostheses
- Where
- Italy
- Volunteers
- 82 people
- Sponsor
- Maria Cecilia Hospital
Heart Valve Diseases
Conventional Versus Mini-Sternotomy for Aortic Valve Surgery
Minimally-invasive operative techniques have been introduced in cardiac surgery. These techniques may have several advantages such as a decrease in post operative pain, lower morbidity and mortality, faster recovery, and a…
- Trial name
- NCT00221663
- Testing
- surgery techniques (sternotomy for aortic valve replacement)
- Where
- France
- Volunteers
- 78 people
- Sponsor
- University Hospital, Bordeaux
Aortic Regurgitation, Aortic Valve Insufficiency
The JenaValve ALIGN-AR Pivotal Trial
To collect information about treatment for symptomatic severe Aortic Regurgitation (AR), which affects the aortic valve in the heart.
- Conditions
- Aortic Regurgitation, Aortic Valve Insufficiency, Aortic Insufficiency, Aortic Valve Disease
- Trial name
- ALIGN-AR (NCT04415047)
- Testing
- JenaValve Trilogy Heart Valve System
- Where
- 30 sites in United States
- Volunteers
- 180 people
- Sponsor
- JenaValve Technology, Inc.
Aortic Valvular Surgery
Pharmacological Postconditioning During the Aortic Valvular Surgery
Primary objective: To evaluate the efficacy of the cyclosporin A administration to induce a cardioprotection during the valvular surgery.
- Trial name
- PC Pharma CVA (NCT00987207)
- Testing
- cyclosporine A, No injection
- Where
- France
- Volunteers
- 56 people
- Sponsor
- Hospices Civils de Lyon
Aortic Regurgitation Disease, Aortic Valve Calcification
Valvular Assessment of New Generation Aortic Replacement Devices
The VANGUARD study is an open-label, prospective, randomized trial comparing the long-term outcomes of two advanced bioprosthetic aortic valves, Dafodil® and INSPIRIS Resilia®, in patients undergoing aortic valve replacement…
- Conditions
- Aortic Regurgitation Disease, Aortic Valve Calcification, Bicuspid Aortic Valve Disease
- Trial name
- VANGUARD (NCT06688448)
- Testing
- Dafodil prosthesis, Aortic Valve Replacement - Inspires Resilia prosthesis
- Where
- Brazil
- Volunteers
- 200 people
- Sponsor
- Instituto Dante Pazzanese de Cardiologia