Clinical trials: Valvulopathy
Mitral Valve Regurgitation, Mitral Regurgitation
The MitraClip® EXPAND Study of the Next Generation of MitraClip® Devices
The MitraClip EXPAND Study (A Contemporary, Prospective Study Evaluating Real-world Experience of Performance and Safety for the Next Generation of MitraClip Devices) is designed to confirm the safety and performance of the…
- Trial name
- NCT03502811
- Testing
- MitraClip NTR/XTR System
- Where
- 57 sites in United States, Germany and 6 more
- Volunteers
- 1,041 people
- Sponsor
- Abbott Medical Devices
Tricuspid Valve Insufficiency, Tricuspid Regurgitation
TRI-REPAIR: TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System
The current management of tricuspid regurgitation (TR) is either conservative (by medication) or by surgery, usually in concomitant with other valves repair or replacement.
- Conditions
- Tricuspid Valve Insufficiency, Tricuspid Regurgitation, Tricuspid Valve Regurgitation, Cardiovascular Diseases
- Trial name
- TRI-REPAIR (NCT02981953)
- Testing
- Cardioband Tricuspid
- Where
- 8 sites in France, Germany and 1 more
- Volunteers
- 40 people
- Sponsor
- Edwards Lifesciences
Heart Valve Diseases
Dabigatran Etexilate in Patients With Mechanical Heart Valves
To validate the dosing algorithm for dabigatran etexilate in patients receiving a mechanical heart valve.
- Trial name
- RE-ALIGN (NCT01452347)
- Testing
- warfarin 1mg, dabigatran etexilate intermediate dose, dabigatran etexilate low dose
- Where
- 40 sites in Belgium, Canada and 8 more
- Volunteers
- 328 people
- Sponsor
- Boehringer Ingelheim
Aortic Stenosis
Aortic Stenosis and PhosphodiEsterase iNhibition With Aortic Valve Replacement (ASPEN-AVR): A Pilot Study
Currently, aortic stenosis (AS) is considered a "surgical disease" with no medical therapy available to improve any clinical outcomes, including symptoms, time to surgery, or long-term survival.
- Trial name
- ASPEN-AVR (NCT01272388)
- Testing
- Tadalafil
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Washington University School of Medicine
Aortic Stenosis
Correlation of Auscultatory Severity of Aortic Stenosis With Trans Thoracic Echocardiography
According to the 2006 ACC/AHA practice guidelines for valvular heart disease, patients with asymptomatic aortic stenosis(AS) should have screening transthoracic echocardiograms (TTE) performed annually for severe disease, every…
- Trial name
- Cassette (NCT01605669)
- Testing
- Tranthoracic Echocardiogram, Cardiac Ascultation Recordings with Electronic stethoscope
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- United States Naval Medical Center, San Diego
Severe, Symptomatic Aortic Stenosis
The SOLACE-AU Clinical Trial
The objective of the study is to observe the safety, efficacy and cost effectiveness of the Edwards SAPIEN XT valve for the treatment of severe calcific degenerative aortic stenosis.
- Trial name
- SOLACE-AU (NCT01675596)
- Testing
- TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
- Where
- 11 sites in Australia
- Volunteers
- 199 people
- Sponsor
- Edwards Lifesciences
Mitral Regurgitation, Mitral Insufficiency
5-Year Follow-Up Safety and Performance Evaluation of the Medtentia Annuloplasty Ring in Adults
Single-center clinical investigation is to evaluate long-term safety and performance of the Medtentia Annuloplasty Ring (MAR) in 11 patients who underwent successful mitral valve (MV) surgery using Medtentia's MAR system in…
- Trial name
- NCT04161079
- Testing
- Medtentia Annuloplasty Ring (MAR)
- Where
- Finland
- Volunteers
- 12 people
- Sponsor
- Medtentia International Ltd Oy
Aortic Stenosis
The Medtronic CoreValve™ Evolut R™ CE Mark Clinical Study
To assess the safety and clinical performance of the CoreValve™ Evolut R™ System.
- Trial name
- NCT01876420
- Testing
- The CoreValve™ Evolut R TAV™ system
- Where
- 6 sites in Australia, New Zealand and 1 more
- Volunteers
- 60 people
- Sponsor
- Medtronic Cardiovascular
Tricuspid Valve Regurgitation
Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System
The study is a multi-center, prospective, early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function, provide guidance for future clinical study designs and…
- Trial name
- NCT02471807
- Testing
- Edwards FORMA Tricuspid Transcatheter Repair System
- Where
- 5 sites in United States
- Volunteers
- 34 people
- Sponsor
- Edwards Lifesciences
Williams Syndrome, Anxiety
Buspirone Treatment of Anxiety in Williams Syndrome
The purpose of this study is to do a preliminary assessment of whether buspirone is effective, safe, and tolerable in the treatment of anxiety in children, adolescents, and adults with Williams syndrome.
- Trial name
- NCT04807517
- Testing
- Buspirone
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Massachusetts General Hospital
Heart Valve Diseases
Atrovastatin for Preventing Atrial Fibrillation Following Open Cardiac Valve Repair
The purpose of the investigation is to determine whether Atrovastatin as anti-inflammatory agent can be effective in preventing from atrial fibrillation incidence in patients whom undergone open cardiac surgery for their heart…
- Trial name
- NCT02084069
- Testing
- Atorvastatin
- Where
- Iran
- Volunteers
- 58 people
- Sponsor
- Urmia University of Medical Sciences
Valvular Heart Disease
The PROTEMBO C Trial
The PROTEMBO C Trial is an international, multi-center, single arm, non-inferiority study of the safety and performance of using the ProtEmbo System for cerebral embolic protection in subjects with severe native aortic valve…
- Trial name
- NCT04618718
- Testing
- cerebral embolic protection during TAVR
- Where
- 8 sites in Germany, Latvia and 1 more
- Volunteers
- 64 people
- Sponsor
- Protembis GmbH
Aortic Valve Disorder
Frequency of Reduced Leaflet Motion After Surgical Aortic Valve Replacement and Transcatheter Aortic Valve Replacement.
This is a prospective, randomized pilot study in patients undergoing Sugical Aortic Valve Replacement (SAVR) and Transcatheter Aortic Valve Replacement (TAVR) to estimate the incidence of reduced leaflet motion and assess the…
- Trial name
- NCT02696226
- Testing
- SAVR Warfarin, SAVR Aspirin, TAVR Warfarin and clopidogrel
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- The Cleveland Clinic
Aortic Valve Stenosis
Medtronic Evolut™ EXPAND TAVR I Feasibility Study
The purpose of the study is to obtain safety and effectiveness data of the Medtronic Evolut™ PRO+ TAVR System for the treatment of severe, asymptomatic aortic stenosis.
- Trial name
- NCT04639258
- Testing
- Medtronic Evolut™ PRO+ System
- Where
- 8 sites in United States, Australia and 3 more
- Volunteers
- 11 people
- Sponsor
- Medtronic Cardiovascular
Aortic Stenosis
Self-Centering Guide Catheter Feasibility Study
An evaluation of the feasibility of using the Self-Centering Guide Catheter to deliver a guide wire across a stenotic native aortic valve into the left ventricle.
- Trial name
- NCT02639494
- Testing
- Self-Centering Guide Catheter
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Boston Scientific Corporation
Heart Valve Disease
D-Dimer Determined Anticoagulation INTENSITY in Patients With Mechanical Valve Replacement
The optimal intensity of oral anticoagulation in China patients undergoing mechanical valve replacements is still controversial due to the different risk profiles of thrombophilia and bleeding in Chinese patients.
- Trial name
- 3D-INTENSITY (NCT01996657)
- Testing
- Warfarin
- Where
- 2 sites in China
- Volunteers
- 772 people, healthy volunteers welcome
- Sponsor
- Wuhan Asia Heart Hospital
Bradycardia, Tachycardia
Randomized Study of the Use of Warfarin During Pacemaker or ICD Implantation in Patients Requiring Long Term Anticoagulation
Patients requiring long term anticoagulation often undergo transition of their warfarin to heparin in anticipation of invasive surgical procedures such as pacemaker or ICD implantation.
- Conditions
- Bradycardia, Tachycardia, Atrial Fibrillation, Valvular Heart Disease
- Trial name
- NCT00721136
- Testing
- continue warfarin through the procedure, Hold warfarin, Warfarin held with heparin transition.
- Where
- 2 sites in United States
- Volunteers
- 104 people
- Sponsor
- Johns Hopkins University
Aortic Valve Disease, Aortic Stenosis
EDWARDS INTUITY Valve System FOUNDATION Study
The purpose of this active post-market surveillance study is to confirm the safety and effectiveness of the EDWARDS INTUITY Valve System in the study population.
- Conditions
- Aortic Valve Disease, Aortic Stenosis, Rapid Deployment Valves
- Trial name
- FOUNDATION (NCT02338154)
- Where
- 27 sites in Austria, Denmark and 7 more
- Volunteers
- 516 people
- Sponsor
- Edwards Lifesciences
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
Severe Aortic Stenosis
Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement
The purpose of the study is to evaluate the safety and efficacy of the Medtronic CoreValve® System in the treatment of symptomatic severe aortic stenosis in subjects who have a predicted high risk for aortic valve surgery and/or…
- Trial name
- NCT01240902
- Testing
- Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI), Surgical Aortic Valve Replacement (SAVR)
- Where
- 45 sites in United States
- Volunteers
- 1,453 people
- Sponsor
- Medtronic Cardiovascular