Clinical trials: Heart Valve Surgery
Heart Diseases, ASD - Atrial Septal Defect
Abbott Structural Heart Device Registry
The Abbott Structural Heart (SH) Registry is being conducted to confirm the safety and performance of Abbott's SH devices in a post-market, real-world setting.
- Conditions
- Heart Diseases, ASD - Atrial Septal Defect, VSD - Muscular Ventricular Septal Defect, PFO - Patent Foramen Ovale
- Trial name
- SH-Registry (NCT06590467)
- Testing
- Amplatzer™ Occlusion Devices, Epic™ Surgical Tissue Heart Valve devices
- Where
- 36 sites in United States, Denmark and 8 more
- Volunteers
- 2,500 people
- Sponsor
- Abbott Medical Devices
Mitral Valve Disease, Mitral Valve Surgery
Registry for Mitral Valve Surgery at Department of Cardiac Surgery University Hospital of Basel/ Switzerland
A registry is installed to collect (pre-, intra- and postoperative) data on patients undergoing mitral valve surgery at the Department for Cardiac Surgery of Universitätsspital Basel/ Switzerland since 2009.
- Trial name
- NCT03587688
- Testing
- mitral valve surgery
- Where
- Switzerland
- Volunteers
- 701 people
- Sponsor
- University Hospital, Basel, Switzerland
Aortic Valve Disease
Outcomes of Surgery of Aortic Valve
Overall Goal: To study the outcomes of patients undergoing aortic valve surgeries, different approaches such as standard aortic valve replacement, aortic valve repair, novel techniques as Ozaki's procedure and their subsequent…
- Trial name
- Aortic Surgery (NCT04277572)
- Testing
- Aortic valve replacement
- Volunteers
- 30 people
- Sponsor
- Assiut University
Heart Valve Diseases, Surgery
Individualised Follow-up After Valve Surgery
This study aims to investigate the effect of an intervention consisting of early, individualised outpatient follow-up after heart valve surgery on unplanned readmissions and death within 180-days after discharge.
- Conditions
- Heart Valve Diseases, Surgery, Readmission
- Trial name
- INVOLVE (NCT03053778)
- Testing
- Early follow-up
- Where
- Denmark
- Volunteers
- 1,414 people
- Sponsor
- Odense University Hospital
Valve Heart Disease, Coronary Artery Disease
Construction of a Prospective Cohort Database for the Perioperative Period of Cardiac Surgery
Cardiovascular disease (CVD) is the leading cause of global morbidity and mortality, with its prevalence increasing significantly from 1990 to 2019.
- Conditions
- Valve Heart Disease, Coronary Artery Disease, Coronary Heart Disease, Aortic Diseases
- Trial name
- NCT07662317
- Testing
- Cardiac surgey
- Where
- China
- Volunteers
- 10,000 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Coronary Artery Disease, Valvular Heart Disease
The ABC Trial Does All-Blood Cardioplegia Prevent Blood Transfusion in Cardiac Surgery? A Single Centre Pilot Study
This study is a single centre pilot for a randomized trial comparing all-blood cardioplegia to more dilute 4:1 blood cardioplegia during cardiac surgery.
- Trial name
- ABC (NCT01623193)
- Testing
- All-blood cardioplegia, Standard cardioplegia
- Where
- Canada
- Volunteers
- 48 people
- Sponsor
- Pam Trenholm
Cardiac Surgery, Cardiopulmonary Bypass
Pentastarch Use in Cardiac Surgery
Patients undergoing cardiac surgery with cardiopulmonary bypass require significant fluid administration. Fluids are used routinely to replace blood lost during and after surgery.
- Trial name
- NCT00182377
- Testing
- Pentastarch (displace either 500 ml or 1000 ml of pump prime with pentastarch)
- Where
- Canada
- Sponsor
- Hamilton Health Sciences Corporation
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
Aortic Regurgitation
Cardiac T1 Mapping Enables Risk Prediction of LV Dysfunction After Surgery for Aortic Regurgitation
To assess whether cardiac T1 mapping for detection of myocardial fibrosis enables preoperative identification of patients at risk for early left ventricular dysfunction after surgery of aortic regurgitation.
- Trial name
- NCT05332184
- Testing
- aortic valve surgery
- Volunteers
- 40 people
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
Mycobacterium Chimaera Infections
Prosthetic Valve and Graft Endocarditis With Mycobacterium Chimaera
Mycobacterium chimaera infections have occurred in post-cardiac surgery patients in association with contaminated cardiac bypass heater-cooler devices. So far optimal therapeutical concepts are not clear.
- Trial name
- NCT04429256
- Testing
- data collection
- Where
- Switzerland
- Volunteers
- 7 people
- Sponsor
- University Hospital, Basel, Switzerland
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
Mitral Valve (MV) Regurgitation
ACCESS-Europe A Two-Phase Observational Study of the MitraClip® System in Europe
The MitraClip System enables the European physicians an alternative therapeutic option for patients with mitral regurgitation (MR).
- Trial name
- ACCESS-EU (NCT01288976)
- Testing
- MitraClip, Medical Management, Mitral Valve Surgery
- Where
- Germany
- Volunteers
- 721 people
- Sponsor
- Abbott Medical Devices
Mitral Valve or Aortic Valve Replacement
A Retrospective Study to Collect the Data From the Patients Who Had the Perimount Heart Valve Replacement Surgery in China During 2001 to 2007
The objective of the study is to obtain the clinical data from patients who had the Perimount Heat Valve (Type:6900P and 2900) Replacement Surgery in Guangdong General Hospital during 2001-2007 in order to evaluate the performace…
- Trial name
- NCT02381678
- Testing
- Perimount 2900/6900 Heart Valve
- Where
- China
- Volunteers
- 225 people
- Sponsor
- Edwards (Shanghai) Lifesciences Medical Supplies Co., Ltd.
Mitral Valve Insufficiency, Atrial Fibrillation
Left Atrial Distensibility to Predict Left Ventricular Filling Pressure and Prognosis in Patients With Severe Mitral Regurgitation
A large left atrial (LA) volume, which represents chronic diastolic dysfunction, is associated with a poor outcome, regardless of systolic function.
- Conditions
- Mitral Valve Insufficiency, Atrial Fibrillation, Heart Failure
- Trial name
- NCT01172184
- Testing
- Cardiac catheterization
- Where
- Taiwan
- Volunteers
- 111 people, healthy volunteers welcome
- Sponsor
- Kaohsiung Veterans General Hospital.
Mitral Insufficiency, Pulmonary Arterial Hypertension
Surgical Valvuloplasty for Congenital Mitral Insufficiency
Congenital mitral insufficiency is one of the most common valvular diseases in the pediatric population worldwide, carrying a high morbidity and mortality risk if not treated immediately and properly.
- Trial name
- NCT03567668
- Testing
- mitral valvuloplasty
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Hong Liu
Severe Aortic Valve Stenosis
In-vitro Benchmarking of Currently Available Heart Valve Prostheses for Surgical and Percutaneous Treatment of Aortic Stenosis With Small Annulus, Followed by In-vivo Validation
The general objective of this study is to compare in vitro and in vivo the hemodynamic performance of different types of aortic valve prostheses and possible surgical implantation techniques.
- Trial name
- SurPASS (NCT06859255)
- Testing
- MRI
- Where
- 2 sites in Italy
- Volunteers
- 200 people
- Sponsor
- IRCCS Policlinico S. Donato
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
Mitral Valve or Aortic Valve Replacement
Clinical Study to Evaluate the Performance of Perimount Heart Valve in Chinese Patients
To recruit patients who implanted with Perimount Heart Valve (Type Number: 6900PTFX or 2800TFX) from three hospitals in China. To track the patients'situations during one year after surgery and to collect the relevant clinical…
- Trial name
- NCT02400489
- Where
- 3 sites in China
- Volunteers
- 265 people
- Sponsor
- Edwards Lifesciences
Severe Aortic Stenosis
Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI).
The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients…
- Trial name
- SURTAVI (NCT01586910)
- Testing
- Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI), Surgical Aortic Valve Replacement (SAVR), Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 86 sites in United States, Canada and 7 more
- Volunteers
- 1,746 people
- Sponsor
- Medtronic Cardiovascular
Apical Hypertrophic Cardiomyopathy
Surgical Treatment of the Patients With Restrictive Phenotype of the Hypertrophic Cardiomyopathy Without LVOT Obstruction
Hypertrophic cardiomyopathy - is an inherited disease characterized by pronounced genetic and phenotypic heterogeneity. There are two most common anatomic variants of cardiac hypertrophy: subaortic and submitral phenotypes.
- Trial name
- NCT06977646
- Testing
- Surgical transaortic left ventricular cavity remodeling in patients with apical hypertrophic cardiomyopathy without left ventricular outflow tract obstruction
- Where
- Russia
- Volunteers
- 50 people
- Sponsor
- Petrovsky National Research Centre of Surgery