Clinical trials: Bicuspid Valve Disorder
Mitral Regurgitation, Mitral Valve Regurgitation
MitraClip NT System Post-marketing Surveillance Study - Japan
The purpose of the MitraClip post-marketing clinical use surveillance study is to observe the frequency, type and degree of adverse device effects and adverse events in order to assure the safety of the new medical device, and to…
- Trial name
- MitraClip NT (NCT03500692)
- Testing
- MitraClip NT System
- Where
- 40 sites in Japan
- Volunteers
- 500 people
- Sponsor
- Abbott Medical Devices
Mitral Valve Insufficiency
The Use of Paravertebral Block for Cardiac Surgery
Pain after robotic cardiac surgery is a known problem and is often difficult to manage. Paravertebral nerve blocks are a proven method of pain relief following thoracotomy.
- Trial name
- NCT02180893
- Testing
- Paravertebral Block
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- NYU Langone Health
Coronary Artery Disease, Coronary Artery Stenoses
Comparison of Sternal Wound Infiltration With Liposomal Bupivacaine v. Bupivacaine Hydrochloride
The aim of this study is to evaluate the analgesic efficacy and safety of wound infiltration with liposomal bupivacaine (LB) in patients undergoing cardiac surgery with sternotomy and cardiopulmonary bypass (CPB) and compare it…
- Conditions
- Coronary Artery Disease, Coronary Artery Stenoses, Valve Regurgitation, Mitral, Valve Regurgitation, Tricuspid
- Trial name
- NCT03270514
- Testing
- Exparel Injectable Product, Bupivacaine Hydrochloride
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Kathirvel Subramaniam
Mitral Valve Regurgitation
Expanded Clinical Study of the Tendyne Mitral Valve System
The purpose of this study is to evaluate the safety and performance of the Tendyne Mitral Valve System in the treatment of severe mitral regurgitation in patents with functional disability greater than or equal to NYHA Class II…
- Trial name
- NCT02321514
- Testing
- Tendyne Mitral Valve System
- Where
- 40 sites in United States, Australia and 8 more
- Volunteers
- 191 people
- Sponsor
- Abbott Medical Devices
Mitral Valve Insufficiency, Coronary Artery Disease
Comparing the Effectiveness of Repairing Versus Replacing the Heart's Mitral Valve in People With Severe Chronic Ischemic Mitral Regurgitation
People with coronary artery disease (CAD) or people who have had a heart attack may develop a leak in the mitral valve of their heart and may therefore need to undergo surgery to fix the valve.
- Trial name
- NCT00807040
- Testing
- Mitral Valve Repair with Annuloplasty, Mitral Valve Replacement
- Where
- 21 sites in United States, Canada
- Volunteers
- 251 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Mitral Valve Insufficiency, Mitral Valve Regurgitation
EVEREST II Pivotal Study High Risk Registry (HRR)
Prospective, multi-center, single arm registry. Clinical follow-up at discharge, 30 days, 6, 12, 18 and 24, months, and 3, 4 and 5 years.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation
- Trial name
- HRR (NCT01940120)
- Testing
- Percutaneous mitral valve repair using MitraClip implant
- Where
- 2 sites in United States
- Volunteers
- 78 people
- Sponsor
- Abbott Medical Devices
Mitral Valve Disease
Mitral Implantation of TRAnscatheter vaLves
The purpose of this trial is to establish the safety and feasibility of the Edwards SAPIEN XT™and SAPIEN 3™ device and delivery systems in patients with severe symptomatic calcific mitral valve disease with severe mitral annular…
- Trial name
- MITRAL (NCT02370511)
- Testing
- Transcatheter Mitral Valve Replacement
- Where
- 15 sites in United States
- Volunteers
- 91 people
- Sponsor
- Mayra Guerrero
Severe Degenerative Mitral Regurgitation Due to Mid-segment Posterior Leaflet Prolapse
Observational Registry on the HARPOON Device
To collect data on the HARPOON™ Mitral Valve Repair System for use in patients with severe degenerative mitral regurgitation due to posterior leaflet prolapse.
- Trial name
- REPLICATE (NCT04393779)
- Testing
- HARPOON Beating Heart Mitral Valve Repair System (MVRS)
- Where
- 7 sites in Germany, Spain and 1 more
- Volunteers
- 26 people
- Sponsor
- Edwards Lifesciences
Dental Caries
Clinical Performance of Incremental and Bulk Fill Composites in Class II Restorations
This study will examine the clinical performance of Class II restorations over a three year period with 3 composite resins - a conventional composite resin, a flowable composite resin and a bulk placed and cured composite resin.
- Trial name
- NCT02889835
- Testing
- Supreme Universal Restorative, Supreme Flowable Restorative, Bulk Fill Flowable Restorative
- Where
- United States
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Solventum US LLC
Mitral Valve Insufficiency, Mitral Valve Disease
PARTNER 3 Trial - Mitral Valve in Valve
To assess the safety and effectiveness of the SAPIEN 3 transcatheter heart valve in patients with a failing mitral bioprosthetic valve.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Disease, Mitral Valve Regurgitation, Heart Failure
- Trial name
- NCT03193801
- Testing
- Edwards SAPIEN 3 transcatheter valve, Model 9600TFX
- Where
- 12 sites in United States, Australia and 1 more
- Volunteers
- 53 people
- Sponsor
- Edwards Lifesciences
Bicuspid Aortic Valve, Thoracic Aortic Aneurysm
The Effect of Losartan in Bicuspid Aortic Valve Patients
The specific aims of this study are to: Establish baseline levels of circulating MMP-2 and -9 , TIMP-1and- 2 and TGFB levels in individuals with bicuspid aortic valve and ascending aortic or aortic sinus measurements >40mm.
- Trial name
- NCT01390181
- Testing
- Cozaar
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- University of Michigan
Dental Caries
Clinical Study on a New Flowable Composite as a Restorative in Adult Teeth
Study hypothesis: a new, low polymerization stress flowable composite performs no differently to a conventional, highly filled composite filling material when used as a restorative in small cavities in back teeth.
- Trial name
- NCT01369108
- Testing
- Flowable composite, Conventional composite restorative
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Solventum US LLC
Mitral Valve Insufficiency, Heart Valve Diseases
NeoChord TACT Post-Market Surveillance Registry
To monitor the long-term performance of the CE Marked NeoChord Artificial Chordae Delivery System
- Conditions
- Mitral Valve Insufficiency, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases
- Trial name
- NCT01784055
- Where
- 7 sites in France, Germany and 3 more
- Volunteers
- 126 people
- Sponsor
- NeoChord
Mitral Valve Insufficiency
Edwards PASCAL Transcatheter Valve Repair System Registry
This registry will collect prospective and retrospective clinical data on patients treated with the Edwards PASCAL Transcatheter Valve Repair System outside of the Post-Market Clinical Follow-up (PMCF) study.
- Trial name
- PASCALRegistry (NCT04443218)
- Testing
- Edwards PASCAL Transcatheter Valve Repair System
- Where
- 14 sites in Germany, Switzerland
- Volunteers
- 220 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
Barlow's Disease, Prolapse; Mitral
Minimally Invasive or Conventional Edge-To-Edge Repair for Severe Mitral Regurgitation Due to Bileaflet Prolapse in Barlow's Disease: Does the Surgical Approach Have an Impact on the Long-term Results?
The study evaluates the long-term results of patients affected by bileaflet prolapse in Barlow's Disease, treated with edge-to-edge technique between 1997 and 2011.
- Trial name
- NCT04002648
- Testing
- Right minithoracotomy, Sternotomy
- Volunteers
- 208 people
- Sponsor
- Ospedale San Raffaele
Mitral Regurgitation
Molecular Mechanisms of Volume Overload-Aim 1(SCCOR in Cardiac Dysfunction and Disease)
The investigators hypothesize that beta-1 receptor blockade (ß1-RB) attenuates extracellular matrix (ECM) degradation and progressive adverse Left Ventricular (LV) remodeling and failure in the volume overload of mitral…
- Trial name
- P1A1 (NCT01052428)
- Testing
- metoprolol succinate (Toprol XL)
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Coronary Artery Disease, Mitral Valve Regurgitation
Magna® Mitral Pericardial Bioprostheses Post-Approval Study Protocol
The purpose of the study is to demonstrate the long term safety and effectiveness of the Carpentier-Edwards® PERIMOUNT Magna Mitral Valves in patients undergoing mitral valve replacement with or without concomitant procedures…
- Conditions
- Coronary Artery Disease, Mitral Valve Regurgitation, Mitral Valve Incompetence, Heart Failure
- Trial name
- NCT00853632
- Testing
- CEP MAGNA MITRAL PERICARDIAL BIOPROSTHESES
- Where
- 15 sites in United States, Austria and 2 more
- Volunteers
- 329 people
- Sponsor
- Edwards Lifesciences
Mitral Regurgitation
Treatment of Mitral Regurgitation Using a Minimally Invasive Approach With the HARPOON Device.
To evaluate the long-term safety and performance of the HARPOON™ MVRS for use in patients presenting with severe degenerative mitral regurgitation due to posterior leaflet prolapse in the post-market phase.
- Trial name
- ASCEND (NCT04382612)
- Testing
- HARPOON Beating Heart Mitral Valve Repair System (MVRS)
- Where
- 10 sites in Austria, Germany and 2 more
- Volunteers
- 42 people
- Sponsor
- Edwards Lifesciences
Cardiovascular Disease
A New Operation for the Treatment for Long-standing Atrial Fibrillation
Atrial fibrillation(AF) often occurs in patients with mitral valve disease. Both mitral replacement and mitral valve plasty are the effective methods to the mitral valve disease.
- Trial name
- ANOLAF (NCT03347695)
- Testing
- Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure(selected patients), Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure
- Where
- China
- Volunteers
- 140 people
- Sponsor
- Fujian Medical University