Clinical trials: Cardiac and Aortic Surgery
Echocardiography, Aortic Valve
Short- and Medium-term Results of New Generation Aortic
Over the past decade, aortic valve replacement surgery has undergone significant changes in terms of both the approaches and the prostheses used.
- Conditions
- Echocardiography, Aortic Valve, Cardiac Surgery, Mortality
- Trial name
- RVANG (NCT05055089)
- Where
- France
- Volunteers
- 172 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Aortic Valve Disease, Prosthesis; Cardiac, Heart, Functional Disturbance as Result
Aortic Valve Replacement Above the Aortic Annulus (SA-AVR) With the Carpentier-Edwards Magna-Ease Bioprosthesis
Surgical valve replacement is commonly performed in patients with severe aortic valve disease. In small aortic annulus, implantation of bioprosthetic valves can be associated with limited functional capacity.
- Trial name
- SA-AVR (NCT03976817)
- Testing
- aortic valve replacement
- Where
- France
- Volunteers
- 117 people
- Sponsor
- Centre Chirurgical Marie Lannelongue
Cardio-pulmonary Bypass, AORTIC VALVE DISEASES
Clinical Validation of a Novel Handsfree Doppler Ultrasound Device, RescueDoppler, in Adult Cardiac Surgery Patients
The goal of this study is to evaluate a new device called RescueDoppler (RD), which measures continuous blood flow in the common carotid artery. The device is handsfree and operator- independent.
- Conditions
- Cardio-pulmonary Bypass, AORTIC VALVE DISEASES, Coronary Arterial Disease (CAD), Aortic Aneurysm of the Proximal Arch
- Trial name
- RD_CPB (NCT06637540)
- Testing
- RescueDoppler
- Where
- 3 sites in Norway
- Volunteers
- 42 people
- Sponsor
- St. Olavs Hospital
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
Aortic Stenosis, Amyloid
Atrial Amyloid May Influence Outcomes in Patients Undergoing Surgical Aortic Valve Replacement
Background (Context): Some older adults who undergo surgery to replace a narrowed heart valve (called aortic stenosis) may also have small protein deposits in their heart.
- Trial name
- AORTICMARKER (NCT07105501)
- Where
- Spain
- Volunteers
- 110 people
- Sponsor
- Germans Trias i Pujol Hospital
Mechanical Aortic and/or Mitral Valve Replacement Operation
Patient International Normalised Ratio (INR) Self-Testing Program
The aims of the study are to prove correlation between laboratory and patient self-testing (PST) measurements, estimation of INR variability within a target therapeutic zone and frequency of hemorrhagic and/or thromboembolic…
- Trial name
- NCT00925197
- Testing
- INR self-testing program
- Volunteers
- 206 people
- Sponsor
- University Hospital, Clermont-Ferrand
Aortic Stenosis, Severe
The CardioFit Trial: Exercise Training Before Aortic Valve Surgery
The CardioFit Trial: The feasibility, safety and tolerability of an exercise training programme in patients with severe aortic stenosis prior to aortic valve replacement surgery: A feasibility trial To investigate if a Structured…
- Trial name
- CardioFit (NCT06818110)
- Testing
- Exercise
- Where
- United Kingdom
- Volunteers
- 15 people
- Sponsor
- University Hospital Southampton NHS Foundation Trust
Aortic Stenosis
The Effects of High Spinal Anesthesia on Heart Function, Stress Response and Pain Control in Aortic Valve Surgery
This study is looking at the effects of high spinal anesthesia (also known as total spinal anesthesia) combined with general anesthesia versus general anesthesia alone on the following: Stress response: Patients undergoing aortic…
- Trial name
- NCT00348920
- Testing
- High Spinal and General Anesthesia
- Where
- Canada
- Volunteers
- 14 people
- Sponsor
- University of Manitoba
Symptomatic Severe Aortic Stenosis
Portico Next Generation Approval Study
The purpose of this clinical study is to evaluate the acute safety and effectiveness of the next-generation Navitor (Portico™ NG) Transcatheter Aortic Heart Valve as assessed by the rate of all-cause mortality at 30 days and the…
- Trial name
- NCT04011722
- Testing
- Portico™ NG (Navitor) Valve and FlexNav™ Delivery System, Navitor Titan Valve (35mm) Valve and Large FlexNav™ Delivery System
- Where
- 28 sites in United States, Australia and 3 more
- Volunteers
- 333 people
- Sponsor
- Abbott Medical Devices
Cardiac and Aortic Surgery
Echography to Predict Radial Artery Catheterization Failure (EPRAC)
In patients undergoing cardiac or aortic surgery, the placement of a radial KTA is sometimes difficult, the purpose of this study is to do an ultrasound in order to evaluate the diagnostic values of the internal diameter of the…
- Trial name
- EPRAC (NCT04730479)
- Where
- France
- Volunteers
- 330 people
- Sponsor
- University Hospital, Montpellier
Aortic Stenosis, TAVI(Transcatheter Aortic Valve Implantation)
Demographic and Interpopulation Variations in Evaluation and Results of TAVI
The aim of the project is to evaluate demographic, clinical, and laboratory variations in patients with aortic stenosis treated with TAVI in different countries.
- Conditions
- Aortic Stenosis, TAVI(Transcatheter Aortic Valve Implantation), Computed Tomography, Inflammatory Response During Cardiac Surgery
- Trial name
- DIVER-TAVI (NCT07258706)
- Testing
- laboratory biomarker analysis, Computed tomography of aortic root and aorta
- Where
- 5 sites in Italy, Poland and 3 more
- Volunteers
- 800 people
- Sponsor
- Poznan University of Medical Sciences
Aortic Valve Stenosis
Costs, Cognitive Abilities and Quality of Life After Transcatheter Aortic Valve Implantation and Surgical Aortic Valve Replacement
Multicenter, prospective, observational study in aortic stenosis (AS) patients undergoing transcatheter aortic valve implantation (TAVI) or high-risk patients undergoing aortic valve replacement (AVR).
- Trial name
- CCQ (NCT01852552)
- Testing
- transcatheter aortic valve implantation, Aortic Valve Replacement
- Where
- Italy
- Volunteers
- 518 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Inflammation
Efficacy and Safety of Bovine Intestinal Alkaline Phosphatase (bIAP) During Heart Surgery
This multi-centre prospective, randomised, double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of bovine intestinal alkaline phosphatase (bIAP) in reducing the pro-inflammatory post-surgical…
- Trial name
- APPIRED-II (NCT01144611)
- Testing
- bIAP bolus and 8h infusion
- Where
- Netherlands
- Volunteers
- 53 people
- Sponsor
- Alloksys Life Sciences B.V.
AORTIC VALVE DISEASES, Aortic Valve Stenosis and Insufficiency
Post-market Safety and Performance Outcomes of the VIVERE® Bovine Pericardial Bioprosthetic Valve
This study aims to collect post-market safety and performance data related to the procedure and follow-up of the VIVERE Bovine Pericardial Bioprosthetic Valve, when used in accordance with the product's Instructions for Use (IFU).
- Conditions
- AORTIC VALVE DISEASES, Aortic Valve Stenosis and Insufficiency, Aortic Valve Surgery, Mitral Valve Regurgitation
- Trial name
- VITTA (NCT06959836)
- Testing
- VIVERE Bovine Pericardial Bioprosthetic Valve
- Where
- 3 sites in Brazil
- Volunteers
- 150 people
- Sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda.
Gradient Between Radial and Central Aortic Pressure After Cardiopulmonary Bypass
Evaluation of Aortic-Radial Blood Pressure Gradient in Pediatric Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass
Invasive blood pressure monitoring is essential during heart surgery. Usually, doctors measure blood pressure using a small tube (a catheter) placed in an artery, typically in the wrist or arm.
- Trial name
- GARP (NCT07857811)
- Testing
- Placement of a pressure transducer at the accessory port of the CPB arterial cannula
- Where
- 2 sites in Chile
- Volunteers
- 100 people
- Sponsor
- Pontificia Universidad Catolica de Chile
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
Infrarenal Abdominal Aortic Aneurysm
Arterial Stiffness, Blood Pressure and Cardiac Output Study
Comparison of non-invasively obtained central blood pressure using SphygmoCor and invasively recorded central blood pressure in patients with an AAA that will be treated with EVAR.
- Trial name
- ABC (NCT03469388)
- Testing
- Pulse wave analyses; central blood presaure parameters
- Where
- Netherlands
- Volunteers
- 20 people
- Sponsor
- Rijnstate Hospital
Aortic Valve Stenosis, Regurgitation, Aortic
Comparison of the Balloon-Expandable Edwards Valve and Self-Expandable CoreValve Evolut R or Evolut PRO System for the Treatment of Small, Severely Dysfunctional Surgical Aortic Bioprotheses. The 'LYTEN' Trial
The treatment with transcatheter aortic valve implantation (TAVI) of patients with small (≤23mm) surgical bioprostheses remains a challenge due to the increased transvalvular residual gradients and high rates of severe…
- Conditions
- Aortic Valve Stenosis, Regurgitation, Aortic, Prosthesis Failure
- Trial name
- NCT03520101
- Testing
- TAVI_ViV procedure with Edwards valve, TAVI_ViV procedure with CoreValve system
- Where
- Canada
- Volunteers
- 102 people
- Sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Congenital Heart Disease
Paravertebral Nerve Blocks in Neonates
This study is a prospective, randomized, non-blinded clinical trial examining the use of paravertebral peripheral nerve block in the neonatal and infant populations.
- Trial name
- NCT03408340
- Testing
- Paravertebral Nerve Block, Standard of Care Anesthesia
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Emory University
Aortic Insufficiency
The HAART 300 Annuloplasty Ring Trial Extended Safety and Performance
This investigation is a prospective, non-randomized, multi-center trial to evaluate the extended safety and performance of the HAART model 300 annuloplasty ring when used to surgically repair the aortic valve using a 3-D…
- Trial name
- NCT01732835
- Testing
- HAART 300 Annuloplasty Device
- Where
- 8 sites in Czechia, Germany
- Volunteers
- 68 people
- Sponsor
- Biostable Science & Engineering