Clinical trials: Heart Valve Replacement
Complex Congenital Heart Defect, Dysfunctional RVOT Conduit
COMPASSION S3 Post-Approval Study
This study will monitor device performance and outcomes of the SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted surgical valve…
- Conditions
- Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration
- Trial name
- NCT04860765
- Testing
- SAPIEN 3 THV
- Where
- 19 sites in United States
- Volunteers
- 150 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Insufficiency, Aortic Valve Stenosis
ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves
The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects who are at high or greater risk with a failing aortic bioprosthetic valve.
- Trial name
- NCT05172973
- Testing
- SAPIEN X4/X4S THV
- Where
- 37 sites in United States, Canada
- Volunteers
- 200 people
- Sponsor
- Edwards Lifesciences
Cardiac Double Valve Replacement
Patient Outcome After Cardiac Double Valve Replacement at University Hospital Basel/ Switzerland
To compare patient outcome data after cardiac double valve replacement (aortic and mitral valve) with patient outcome data after aortic valve replacement and mitral valve reconstruction
- Trial name
- NCT03667274
- Testing
- cardiac valve surgery
- Where
- Switzerland
- Volunteers
- 106 people
- Sponsor
- University Hospital, Basel, Switzerland
Aortic Stenosis
Association of Type of Anesthetic and Outcomes in Transfemoral Aortic Valve Replacement
This study proposes to perform a descriptive analysis and pilot observational study looking at the types and quantity of anesthetic agents used and their associations with outcomes among patients scheduled to receive transfemoral…
- Trial name
- NCT02786264
- Testing
- Dexmedetomidine with propofol, Propofol
- Volunteers
- 186 people
- Sponsor
- Yale University
Right Ventricular Dysfunction, Rheumatic Heart Disease
Right Ventricular Echo Assessment in Mitral Valve Replacement
Rheumatic heart disease remains a major health problem in developing countries. It is the most important sequel of rheumatic fever and occurs in about 30% of patients with rheumatic fever.Rheumatic heart disease presents with…
- Trial name
- NCT03549052
- Volunteers
- 120 people
- Sponsor
- Assiut University
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
Aortic Valve Stenosis
The Asian Pacific TAVR Multicenter Registry
The purpose of this study is to evaluate the clinical outcomes of transcatheter aortic valve Replacement (TAVR) in the Asian Pacific population
- Trial name
- AP TAVR (NCT02195102)
- Testing
- Transcatheter aortic valve Replacement
- Where
- 10 sites in China, Japan and 6 more
- Volunteers
- 2,000 people
- Sponsor
- Michael Kang-Yin Lee, MD
Aortic Valve Stenosis, Limited Access Aortic Valve Replacement
Patient Reported Health-Related Quality of Life After Limited Access and Conventional Aortic Valve Replacement
The LIAR-Trial is a single-center, single blind randomized controlled clinical trial comparing patients undergoing isolated AVR via J-shaped upper hemi-sternotomy (UHS) and conventional AVR through a full median sternotomy (FMS).
- Conditions
- Aortic Valve Stenosis, Limited Access Aortic Valve Replacement, Quality of Life
- Trial name
- LIAR (NCT04012060)
- Testing
- Limited access aortic valve replacement., Conventional aortic valve replacement
- Where
- Netherlands
- Volunteers
- 161 people
- Sponsor
- St. Antonius Hospital
Mitral Valve Disease, Damaged Mitral Valve
HALO: A Single Arm Prospective Investigation of the SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve
The purpose of the study is to provide evidence of safety and effectiveness of the study valve. The rationale is to offer a replacement mitral valve for patients with anatomy that is too small for the currently commercially…
- Conditions
- Mitral Valve Disease, Damaged Mitral Valve, Malfunctioning Mitral Heart Valve, Mitral Valve Replacement
- Trial name
- NCT02097420
- Testing
- Mitral valve replacement SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve
- Where
- 24 sites in United States
- Volunteers
- 23 people
- Sponsor
- Abbott Medical Devices
Aortic Stenosis
A Study of Transcatheter Aortic Valve Replacement Case Selection and Valve Sizing Using the ABC Bicuspid Sizing Algorithm
The goal of this study is to learn what effects the ABC Bicuspid Sizing Algorithm has on the clinical outcomes of patients with bicuspid aortic stenosis after having a transcatheter aortic valve replacement (TAVR) using the…
- Trial name
- NCT06991517
- Testing
- The ABC Bicuspid Sizing Algorithm
- Where
- 20 sites in Australia, Canada and 6 more
- Volunteers
- 290 people
- Sponsor
- World Health Research Inc.
Aortic Valve Stenosis
HLT Meridian Valve CE Mark Trial
To evaluate the safety and performance of the HLT System in patients with symptomatic heart disease due to severe aortic stenosis who are judged by the Heart Team to be at Intermediate or High Risk for aortic valve replacement…
- Trial name
- RADIANT CE (NCT03805711)
- Testing
- HLT® Transcatheter System
- Where
- Canada
- Volunteers
- 1 people
- Sponsor
- HLT Inc.
Congenital Heart Disease
Retrospective Pulmonary Valve Replacement Imaging
This is a retrospective chart review examining children and adults with history of Tetralogy of Fallot or pulmonary stenosis who have undergone subsequent pulmonary valve replacement.
- Trial name
- NCT00446108
- Where
- 2 sites in United States
- Volunteers
- 153 people
- Sponsor
- Emory University
Aortic Valve Disease, Mitral Valve Disease
Artificial Valve Endocarditis Reduction Trial
The purpose of this study is to investigate whether the Silzone coated sewing cuff reduces the incidence of prosthetic valve endocarditis (PVE).
- Conditions
- Aortic Valve Disease, Mitral Valve Disease, Endocarditis
- Trial name
- AVERT (NCT00590889)
- Testing
- Artificial Mechanical Heart Valve
- Where
- 16 sites in United States, Canada and 6 more
- Volunteers
- 807 people
- Sponsor
- Abbott Medical Devices
Heart Valve Replacement
The German Plug - Registry
In approximately 10-15% of all patients after surgical or interventional heart valve replacement, flapping defects appear as complications in the long-term course, so-called paravalvular / paraprothetic leaks (PVL).
- Trial name
- PLUG (NCT03179969)
- Testing
- paravalvular leak
- Where
- Germany
- Volunteers
- 49 people
- Sponsor
- Stiftung Institut fuer Herzinfarktforschung
Aortic Valve Stenosis
SAPIEN 3 Ultra System PMCF
A post-market study of the Edwards SAPIEN 3 Ultra System in subjects with symptomatic, severe, calcific aortic stenosis.
- Trial name
- NCT04555967
- Testing
- SAPIEN 3 Ultra System
- Where
- 11 sites in Austria, Canada and 6 more
- Volunteers
- 200 people
- Sponsor
- Edwards Lifesciences
Tetralogy of Fallot, Pulmonary Valve Insufficiency
Comparison of Two Pulmonary Valve Replacement Methods to Treat Tetralogy of Fallot
Repair of tetralogy of Fallot (TOF), the most common form of cyanotic congenital heart disease, usually involves surgery on the outflow of the right ventricle (RV) and the pulmonary valve in order to relieve obstruction to blood…
- Conditions
- Tetralogy of Fallot, Pulmonary Valve Insufficiency, Ventricular Dysfunction, Right
- Trial name
- NCT00112320
- Testing
- PVR plus RV remodeling, Standard PVR
- Where
- United States
- Volunteers
- 68 people
- Sponsor
- Boston Children's Hospital
Pleural Effusion, Coronary Artery Bypass
Pleural Effusion Following Cardiac Surgery: Prevalence, Risk Factors and Clinical Features
Pleural effusion is a common complication of cardiac surgery. The aim of this study was to determine the prevalence, characteristics and determinants of clinically significant pleural effusions, defined as those requiring…
- Trial name
- NCT00665015
- Where
- Canada
- Volunteers
- 2,892 people
- Sponsor
- Laval University
Aortic Valve Stenosis
The SAPIEN 3 Ultra System in Intermediate Risk Patients With Symptomatic, Severe Aortic Stenosis
This study will confirm the procedural safety and performance of the SAPIEN 3 Ultra System in subjects with severe, calcific AS who are at intermediate operative risk for standard aortic valve replacement.
- Trial name
- NCT03471065
- Testing
- SAPIEN 3 Ultra Delivery System with the SAPIEN 3 Ultra THV
- Where
- 6 sites in Canada, United Kingdom
- Volunteers
- 100 people
- Sponsor
- Edwards Lifesciences
Cardiac Surgery
Evaluate the Protective Effect of Conditioning With Sevoflurane on the Myocardium
Heart surgery is a considerable source of stress for the myocardium that must be minimized. Troponin Ic is a reliable marker to determine the level of this myocardial stress.
- Trial name
- SUPRA (NCT02851433)
- Testing
- total anaesthesia and postoperative inhaled sedation with Sevoflurane, total intravenous anaesthesia with Propofol.
- Where
- France
- Volunteers
- 82 people
- Sponsor
- Centre Hospitalier Universitaire Dijon
Patients Above 18 Years, Patient Discharge
One Year Pacing Dependency After TAVR
Pace maker implantation after the procedure of TAVR can be estimated at 15% of patients. However, some studies have shown that the conduction disturbances after TAVR could resolve over time, and that roughly between one- and…
- Conditions
- Patients Above 18 Years, Patient Discharge, Pacing Therapy, Aortic Stenosis (Treated With TAVI)
- Trial name
- PACETAVI (NCT06756282)
- Testing
- Pacemaker and defibrillator
- Where
- France
- Volunteers
- 90 people
- Sponsor
- University Hospital, Montpellier