Clinical trials: Surgical Aortic Valve Replacement
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
Aortic Valve Insufficiency, Regurgitation, Aortic Valve
Aortic Valve Replacement With Trifecta(TM)
The purpose of this study is to confirm the clinical safety and effectiveness of the Trifecta valve.
- Conditions
- Aortic Valve Insufficiency, Regurgitation, Aortic Valve, Aortic Valve Incompetence, Aortic Valve Stenosis
- Trial name
- NCT00475267
- Testing
- Trifecta aortic heart valve
- Where
- 5 sites in Canada
- Volunteers
- 203 people
- Sponsor
- Abbott Medical Devices
Use of Dexmedetomidine in Cardiac Surgery (CABG, Valve Replacement or Total Aortic Arch Replacement)
Effect of Dexmedetomidine on Hemodynamics in Cardiac Surgery
It is important to establish a stable haemodynamics in patients undergoing cardiac surgery. Haemodynamic depression is common during induction of anaesthesia [1].
- Trial name
- NCT06958913
- Testing
- Propofol group, Dexmedetomidine
- Where
- Turkey (Türkiye)
- Volunteers
- 52 people
- Sponsor
- Pamukkale University
Aortic Valve Stenosis, Aortic Valve Calcification
Safety and Performance of TAVI of Venus MedTech Aortic Valve Prosthesis
1. objectives Evaluate the performance of Venus MedTech aortic valve prosthesis intervention by femoral artery Evaluate safety and clinical benefit of percutaneous implantation of the Venue MedTech aortic valve prosthesis.
- Trial name
- Venus-A (NCT01683474)
- Testing
- Venus MedTech Aortic Valve Prosthesis
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Venus MedTech (HangZhou) Inc.
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.
Acquired Von Willebrand Disease Secondary to Severe Aortic Stenosis, Heye´s Syndrome
Severe Aortic Stenosis and Acquired Von Willebrand´s Disease: The Impact of Desmopressin in Valve-Replacement Surgery
Acquired Von Willebrand disease (type 2A) has been described in patients with severe aortic stenosis, the association of aortic stenosis and Digestive bleeding due to this phenomena has received the name of Heye´s syndrome.
- Conditions
- Acquired Von Willebrand Disease Secondary to Severe Aortic Stenosis, Heye´s Syndrome, Severe Aortic Stenosis
- Trial name
- NCT01994330
- Testing
- desmopressin
- Where
- Chile
- Volunteers
- 13 people
- Sponsor
- Pontificia Universidad Catolica de Chile
Symptomatic Severe Aortic Stenosis
FlexNav EU CE Mark Study
The purpose of this clinical investigation is to characterize the safety of the next-generation FlexNav™ Delivery System for transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in symptomatic severe aortic…
- Trial name
- NCT03724812
- Testing
- Portico Valve and FlexNav™ Delivery System
- Where
- 6 sites in Denmark, Italy and 2 more
- Volunteers
- 46 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Disease, Surgery--Complications
Immune Responsiveness and Outcome After Aortic Valve Surgery (Measure)
There is considerable morbidity and mortality associated with cardiac surgery. Currently little effort is made to quantify how well the immune system of an individual can cope with inflammation or infection to which they are…
- Conditions
- Aortic Valve Disease, Surgery--Complications, Immune System Disorder
- Trial name
- Measure (NCT04430972)
- Testing
- Aortic valve replacement
- Where
- United Kingdom
- Volunteers
- 150 people
- Sponsor
- Barts & The London NHS Trust
Aortic Stenosis
18-F Sodium Fluoride (18F-NaF) PET for the Assessment of Bioprosthetic Aortic Valve Durability and Outcomes
This is a pilot study in which we will aim to demonstrate successful execution of the imaging protocol and to make observations regarding the calcification activity as measured by 18F-NaF PET/CT and any correlation to 1) valve…
- Trial name
- NCT03095313
- Testing
- 18F-NaF
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Cedars-Sinai Medical Center
Aortic Valve Disease
4D- Flow- MRI After Aortic Valve Surgery
This randomized controlled trial was designed to analyze flow patterns in the ascending aorta with MRI after either Trileaflet reconstruction of the aortic valve with autologous pericardium (TriRec) or surgical valve replacement…
- Trial name
- NCT04223713
- Testing
- TriRec, Aortic valve replacement
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Right Ventricular Dysfunction
TEE 3D RV Assessment for SAVR, Mini AVR, and TAVR
Three-dimensional echocardiography has become a gold standard to assess right ventricular (RV) function, and investigators plan to use 3D transesophageal echocardiography to assess RV function in 3 types of aortic valve…
- Trial name
- NCT05804240
- Testing
- 3D TEE RVEF
- Where
- United States
- Volunteers
- 67 people
- Sponsor
- Thomas Jefferson University
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
Postoperative Delirium, Postoperative Cognitive Dysfunction
Cognitive Outcome After Surgical and Transcatheter Aortic Valve Replacement
Aortic valve stenosis is one of the most common types of heart disease in the aging Western population. While surgical cardiac valve replacement (SAVR) is a standard therapy for patients with aortic stenosis, catheter-assisted…
- Conditions
- Postoperative Delirium, Postoperative Cognitive Dysfunction, Transcatheter Aortic Valve Replacement, Surgical Aortic Valve Replacement
- Trial name
- COSTA (NCT04535076)
- Testing
- Transcatheter Aortic Valve Implantation, Surgical Aortic Valve Replacement
- Where
- Germany
- Volunteers
- 31 people
- Sponsor
- Heart and Brain Research Group, Germany
Quality of Life
Health-related QoL Following TAVI TAo, TAVI TF and AVR
The aim of the study was to evaluate short- and long-term changes in QoL in patients undergoing TAVI and to assess differences in patient QoL when using the TAVI TAo approach compared with the transfemoral approach (TAVI TF) and…
- Trial name
- NCT03583398
- Testing
- transcatheter aortic valve implantation, surgical aortic valve replacement
- Volunteers
- 97 people
- Sponsor
- Medical University of Gdansk
Patients Waiting for Coronary Artery Bypass Graft Surgery, Patients Waiting for Aortic Valve Repair or Replacement
Pre-operative Rehabilitation for Reduction of Hospitalization After Coronary Bypass and Valvular Surgery.
The PREHAB study is a clinical trial where frail patients waiting for heart surgery are randomly chosen to either receive the current standard of care or to participate in an 8-week exercise/education program at a community-based…
- Conditions
- Patients Waiting for Coronary Artery Bypass Graft Surgery, Patients Waiting for Aortic Valve Repair or Replacement, Patients Waiting for Mitral Valve Repair or Replacement, Patients Waiting for Combined Procedures. (CAGB and Valve)
- Trial name
- PREHAB (NCT02219815)
- Testing
- Prehab Intervention
- Where
- 5 sites in Canada
- Volunteers
- 89 people
- Sponsor
- St. Boniface Hospital
Surgery, Survival, Prosthesis
15 Years Outcomes Following Bioprosthetic vs Mechanical Aortic Valve Replacement Between 50-65 Years
Currently there is an increase in the use of bioprosthesis worldwide (> 70% according to national data of the Spanish Society of Thoracic and Cardiovascular Surgery).
- Conditions
- Surgery, Survival, Prosthesis, Valve Heart Disease
- Trial name
- ANDALVALVE (NCT03239509)
- Testing
- bioprosthesis implantation between 2000-2015, mechanical prosthesis implantation between 2000-2015
- Where
- 7 sites in Spain
- Volunteers
- 1,200 people
- Sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Heart Valve Disease
The Effects of Levosimendan on Haemodynamics in Patients Undergoing Elective Aortic Valve Replacement (AVR)Together With Coronary Artery Bypass Grafting (CABG) Surgery
Patients undergoing aortic valve replacement (AVR) surgery with coronary artery bypass grafting (CABG) are at risk of left ventricular dysfunction.
- Trial name
- NCT01210976
- Testing
- levosimendan
- Where
- Finland
- Volunteers
- 24 people
- Sponsor
- Tampere University Hospital
Type A Aortic Dissection, Ascending Aortic Dissection
Outcomes of Aortic Dissection Repair
Type A aortic dissection (TAAD) is a potentially life-threatening pathology associated with significant risk of mortality and morbidity.
- Conditions
- Type A Aortic Dissection, Ascending Aortic Dissection, Aortic Diseases, Aortic Arch
- Trial name
- STAAD (NCT05927090)
- Testing
- Conservative Root- Sparing Aortic Valve Resuspension with or without Hemiarch Repair, Extensive Ascending Aorta Replacement (AAR) with Aortic Root Replacement (ARR), Extensive Ascending Aorta Replacement (AAR) with Total Arch Replacement (TARP)
- Where
- France
- Volunteers
- 1,200 people
- Sponsor
- Centre Cardiologique du Nord
Aortic Valve Disease, Aortic Stenosis
Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement
Prospective, randomized, stratified non blinded multi-center, international, post market trial assessed in a non-inferiority study. The trial has a flexible sample size that will be determined adaptively.
- Trial name
- PERSIST-AVR (NCT02673697)
- Testing
- Perceval valve, other stented biological valve
- Where
- 47 sites in United States, Austria and 10 more
- Volunteers
- 914 people
- Sponsor
- Corcym S.r.l
Aortic Valve Stenosis
Study to Improve Outcomes in Aortic Stenosis
Multi-centre, multi-national, observational, prospective registry in four central full access centres in Germany (2), France (1) and the United Kingdom (1) and up to two satellites per hub (smaller hospitals / office based…
- Trial name
- NCT03112629
- Where
- 2 sites in France, Germany
- Volunteers
- 791 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin