Clinical trials: Heart Valve Replacement
Aortic Valve Stenosis, Heart Valve Diseases
Bleeding in Partial Upper Hemisternotomy Versus Full Sternotomy Aortic Valve Replacement
This is a single-center, open-label, randomized controlled trial. Patients scheduled for aortic valve replacement (AVR) at Karolinska University Hospital in Stockholm, Sweden will be eligible.
- Trial name
- NCT02272621
- Testing
- Minimally invasive aortic valve replacement, Full sternotomy aortic valve replacement
- Where
- Sweden
- Volunteers
- 100 people
- Sponsor
- Karolinska University Hospital
Tricuspid Valve Regurgitation, Heart Valve Disease
The TRICURE EU Pivotal Study
Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System
- Conditions
- Tricuspid Valve Regurgitation, Heart Valve Disease, Cardiovascular Diseases
- Trial name
- TRICURE EU (NCT06581471)
- Testing
- Transcatheter Tricuspid Valve Replacement
- Where
- 8 sites in Belgium, Germany
- Volunteers
- 80 people
- Sponsor
- TRiCares
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 Stenosis
Aortic Stenosis Pre-Transcatheter Aortic Valve Replacement (TAVR) Procedure CT Scan
The purpose of this study is to evaluate contrast media volume, safety and 30-day outcome of patients after a computed tomography (CT) scan.
- Trial name
- NCT01843426
- Testing
- Low-volume, low-concentration contrast (iodixanol - Visipaque 270) CT scan
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Medical University of South Carolina
Aortic Stenosis
Performance and Safety of the Lotus™ Valve With a FLEXible Delivery System
To confirm the acute performance and safety of the Lotus™ Valve Flex System for transcatheter aortic valve replacement (TAVR) in symptomatic patients with severe calcific aortic stenosis who are considered high risk for surgical…
- Trial name
- NCT03043404
- Testing
- Transcatheter aortic valve replacement
- Where
- 2 sites in Australia
- Volunteers
- 4 people
- Sponsor
- Boston Scientific Corporation
Mitral Regurgitation
The EMBRACE Registry: European Post-Market Registry for Catheter Based Mitral Valve Replacement
Post-market registry for post-market surveillance, as part of the post-market plan, for the HighLife transcatheter, transseptal, mitral valve replacement system in a real world commercial setting.
- Trial name
- EMBRACE (NCT07409285)
- Where
- Germany
- Volunteers
- 150 people
- Sponsor
- HighLife SAS
Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
Dual AntiPlatelet Therapies for Prevention of Periinterventional Embolic Events in TAVI
TAVI is increasingly adopted as standard treatment for many subgroups of patients with aortic stenosis. However, due to a lack of data there is yet no TAVI-specific guidance regarding the optimum periinterventional drug regimen.
- Conditions
- Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement, Intracranial Embolism
- Trial name
- DAPT-TAVI (NCT03001960)
- Testing
- Preloading before TAVI, Postloading after TAVI
- Volunteers
- 200 people
- Sponsor
- Charite University, Berlin, Germany
Mitral Insufficiency, Heart Valve Disease
A Clinical Study of the CardiAQ™ TMVI System (Transapical DS)
The purpose of the study is to evaluate the initial short and long-term safety and performance of the CardiAQ™ Transcatheter Mitral Valve Implantation System using the Transapical Delivery System.
- Conditions
- Mitral Insufficiency, Heart Valve Disease, Cardiovascular Disease, Heart Disease
- Trial name
- NCT02478008
- Testing
- CardiAQ TMVI System (Transapical DS)
- Where
- 9 sites in Denmark, France and 2 more
- Volunteers
- 2 people
- Sponsor
- Edwards Lifesciences
Glutathione Peroxidase Activity, Aortic Stenosis
GPx Activity in Subjects With Aortic Stenosis Undergoing TAVR
The aim of this project is to investigate the association of glutathione peroxidase (GPx) and severe aortic stenosis (AS), as well as the impact of transcatheter aortic valve replacement (TAVR) on GPx activity post-procedure.
- Conditions
- Glutathione Peroxidase Activity, Aortic Stenosis, Transcatheter Aortic Valve Replacement
- Trial name
- NCT04268160
- Testing
- Blood draw to measure GPx activity, Blood draw to measure SOD activity, Blood draw to measure Lp(a) levels
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of Florida
Severe Aortic Stenosis, TAVI(Transcatheter Aortic Valve Implantation)
Observational Study Relating to the Long-term Follow-up of Patients with Severe Aortic Stenosis Evaluated for Percutaneous Aortic Valve Replacement (TAVI).
All patients with severe aortic stenosis undergoing evaluation for TAVI are routinely subjected to a series of assessments: Pre-implantation: thoraco-abdominal CT angiography, coronary angiography, echocardiography, clinical…
- Trial name
- ROARING-TAVI (NCT06679517)
- Testing
- TAVI
- Where
- Italy
- Volunteers
- 600 people
- Sponsor
- University Hospital of Ferrara
Severe Aortic Valve Disease
Five-year Outcomes of Rapid-deployment Aortic Valve Replacement With the Edwards Intuity TM Valve
Objectives: This report presents 5-year outcomes of the rapid-deployment Edwards Intuity TM valve in a single-center prospective study.
- Trial name
- NCT04696926
- Testing
- Edwards Intuity TM Valve implantation
- Where
- France
- Volunteers
- 170 people
- Sponsor
- Assistance Publique Hopitaux De Marseille
Acute Myocardial Infarction (AMI), Percutaneous Coronary Intervention (PCI)
BRIDGE Trial: Embedding Consumer-grade mHealth Technologies Into Cardiac Rehabilitation
The purpose of the BRIDGE study is to learn whether supplementing traditional center-based cardiac rehabilitation (CBCR) with a mobile health technology intervention can help patients monitor their health, stay engaged in healthy…
- Conditions
- Acute Myocardial Infarction (AMI), Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Graft Surgery (CABG), Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)
- Trial name
- BRIDGE (NCT07741396)
- Testing
- CBCR, BRIDGE mHealth intervention
- Volunteers
- 30 people
- Sponsor
- University of Illinois Chicago
Cardiac Valve Replacement Complication
Short Term Effect of Vitamin D Supplementation on the Clinical Outcomes in Patients Undergoing Valve Replacement Surgery
This study evaluates the effect of Vitamin D supplementation on ICU and hospital LOS in patients undergoing valve replacement surgery.
- Trial name
- NCT04085770
- Testing
- Alfacalcidol 1 MCG Oral Capsule
- Where
- Egypt
- Volunteers
- 86 people
- Sponsor
- Cairo University
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
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 DISEASES, Thromboembolism
Long-term Anticoagulation With Oral Factor Xa Inhibitor Versus Vitamin K Antagonist After Mechanical Aortic Valve Replacement
This study evaluates the long-term anticoagulation with oral factor Xa inhibitor versus vitamin K antagonist in patients receiving a mechanical aortic valve replacement.
- Trial name
- RENOVATE (NCT04258488)
- Testing
- Rivaroxaban Oral Tablet, Vitamin K antagonist(warfarin)
- Where
- 16 sites in South Korea
- Volunteers
- 1,300 people
- Sponsor
- Joon Bum Kim
Pacemaker, TAVI
TAVI PACER: A Two-step Risk Score for Prediction of Permanent Pacemaker Implantation After TAVI.
The need for permanent pacemaker implantation (PPMI) remains one of the most frequent complications after transcatheter aortic valve implantation (TAVI).
- Conditions
- Pacemaker, TAVI, Risk Score
- Trial name
- TAVI PACER (NCT06542380)
- Testing
- TAVI, pacemaker
- Where
- Germany
- Volunteers
- 1,000 people
- Sponsor
- German Heart Institute
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 Valve Stenosis, Transcatheter Aortic Valve Replacement
Aortic Stenosis With COmplex PCI (ASCOP) Features Retrospective Registry on Contemporary Management and Outcomes
To describe the prevalence and clinical features of patients with severe aortic stenosis undergoing TAVI and concomitant clinically indicated, complex and/or high-risk PCI
- Conditions
- Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement, Angioplasty, Balloon, Coronary, Coronary Artery Disease
- Trial name
- ASCOP (NCT05750927)
- Testing
- Transcatheter aortic valve intervention (TAVI) and percutaneous coronary intervention (PCI)
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Niguarda Hospital
Heart Valve Disease, Mitral Valve (MV) Regurgitation
Cohort Observing Mechanisms, Progression and Sequelae of Valvular Heart Disease
The objective of this study is to evaluate and predict the progression of moderate cardiac valve stenosis and regurgitation using clinical, biological, echocardiographic, computed tomography (CT), and magnetic resonance imaging…
- Conditions
- Heart Valve Disease, Mitral Valve (MV) Regurgitation, Mitral Valve Disease, Mitral Valve Stenosis
- Trial name
- VALVE-COMPASS (NCT07267117)
- Where
- 15 sites in China
- Volunteers
- 10,000 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine