Clinical trials: Bicuspid Valve Disorder
- Condition Bicuspid Valve Disorder
- Funder type Industry (pharma, biotech, devices)
- Has posted results yes
Mitral Regurgitation, Mitral Insufficiency
Feasibility Study of the Tendyne Mitral Valve System in Mitral Annular Calcification
This study is a prospective, single-arm, multi-center feasibility clinical study of the Tendyne Mitral Valve System for the treatment of eligible subjects with symptomatic, severe mitral regurgitation and severe mitral annular…
- Conditions
- Mitral Regurgitation, Mitral Insufficiency, Mitral Annular Calcification, Mitral Annulus Calcification
- Trial name
- NCT03539458
- Testing
- Tendyne Mitral Valve System
- Where
- 4 sites in United States
- Volunteers
- 11 people
- Sponsor
- Abbott Medical Devices
Mitral Regurgitation
Cardiovalve Transfemoral Mitral Valve System
This study is to evaluate the safety and technical performance of the Cardiovalve Transfemoral Mitral Valve System with its associated procedure, to minimize mitral regurgitation.
- Trial name
- AHEAD (NCT03813524)
- Testing
- Cardiovalve Transfemoral Mitral Valve
- Where
- 2 sites in United States
- Volunteers
- 1 people
- Sponsor
- Cardiovalve Ltd.
Coronary Artery Bypass Grafting, Mitral Valve Surgery
Levosimendan in Patients With Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery On Cardiopulmonary Bypass
A study to evaluate levosimendan compared with placebo in reducing the composite event rate of all-cause death, perioperative MI, need for new dialysis, or use of mechanical assist (IABP, LVAD or ECMO) in subjects with reduced…
- Conditions
- Coronary Artery Bypass Grafting, Mitral Valve Surgery, Low Cardiac Output Syndrome
- Trial name
- LEVO-CTS (NCT02025621)
- Testing
- Levosimendan
- Where
- 60 sites in United States, Canada
- Volunteers
- 882 people
- Sponsor
- Tenax Therapeutics, Inc.
Aortic Stenosis, Mitral Stenosis
ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Bioprostheses With a New Tissue Treatment Platform (COMMENCE)
The objective of this trial is to confirm that the modifications to tissue processing, valve sterilization and packaging do not raise any new questions of safety and effectiveness in subjects who require replacement of their…
- Conditions
- Aortic Stenosis, Mitral Stenosis, Aortic Valve Insufficiency, Mitral Valve Insufficiency
- Trial name
- COMMENCE (NCT01757665)
- Testing
- Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M
- Where
- 32 sites in United States, Canada and 1 more
- Volunteers
- 777 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
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
Longstanding Persistent Atrial Fibrillation
Evaluation of the Cardioblate CryoFlex Surgical Ablation System in Longstanding Persistent Atrial Fibrillation
Studies have shown that taking drugs to stay out of AF has limited success. This research is designed to study heart rhythm after surgical therapy, namely by measuring if there are benefits to having surgery to treat Atrial…
- Trial name
- CRYO-AF (NCT01558635)
- Testing
- Cardioblate CryoFlex Surgical Ablation, Mitral Valve surgery, Medtronic Reveal XT Insertable Cardiac Monitor
- Where
- 4 sites in Germany, Israel and 2 more
- Volunteers
- 17 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Mitral Valve Regurgitation
Early Feasibility Study of the Neovasc Tiara™ Mitral Valve System
The purpose of this study is to evaluate the safety and initial performance of the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Transapical Delivery System.
- Trial name
- TIARA-I (NCT02276547)
- Testing
- Mitral valve replacement
- Where
- 10 sites in United States, Belgium and 1 more
- Volunteers
- 27 people
- Sponsor
- Shockwave Medical, Inc.
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
Bicuspid Aortic Valve
Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk Bicuspid Study
The objective of the trial is to evaluate the procedural safety and efficacy of the Medtronic TAVR system in patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR
- Trial name
- NCT03635424
- Testing
- Medtronic TAVR Systems
- Where
- 25 sites in United States
- Volunteers
- 150 people
- Sponsor
- Medtronic Cardiovascular
Mitral Valve Insufficiency
Transcatheter Mitral Valve Replacement System (TMVR) Pilot Study and The Early Feasibility Study of the TMVR Transseptal System
PILOT: The study is a pilot trial to evaluate the safety and performance of the Twelve TMVR System in high risk mitral regurgitation patients.
- Trial name
- NCT02322840
- Testing
- Twelve TMVR Implant, Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement System
- Where
- 32 sites in United States, Australia and 5 more
- Volunteers
- 128 people
- Sponsor
- Medtronic Cardiovascular
Aortic Valve Insufficiency, Aortic Valve Regurgitation
Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra
The purpose of this study is to further evaluate the long-term safety and effectiveness of the Biocor and Biocor Supra Valves.
- Conditions
- Aortic Valve Insufficiency, Aortic Valve Regurgitation, Aortic Valve Stenosis, Aortic Valve Incompetence
- Trial name
- NCT00636987
- Testing
- Biocor and Biocor Supra valves
- Where
- 17 sites in United States
- Volunteers
- 297 people
- Sponsor
- Abbott Medical Devices
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
Mitral Regurgitation
Cardioband With Transfemoral Delivery System
To evaluate the performance and safety of the Cardioband Adjustable Annuloplasty System for repair of functional mitral regurgitation.
- Trial name
- NCT01841554
- Testing
- Cardioband
- Where
- 11 sites in France, Germany and 4 more
- Volunteers
- 62 people
- Sponsor
- Edwards Lifesciences
Mitral Valve Regurgitation
The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study
The purpose of this study is to assess the safety, performance and clinical outcomes of the Edwards PASCAL Transcatheter Mitral Valve Repair (TMVr) System.
- Trial name
- CLASP (NCT03170349)
- Testing
- Mitral Valve Repair
- Where
- 17 sites in United States, Australia and 5 more
- Volunteers
- 124 people
- Sponsor
- Edwards Lifesciences
Mitral Regurgitation, Mitral Insufficiency
Study on Safety and Performance of Medtentia Mitral Valve Repair System in Surgical Repair of Mitral Regurgitation
The purpose of the trial is to demonstrate the safety and performance of the Medtentia Annuloplasty Ring (MAR) during mitral valve repair surgery.
- Trial name
- NCT01678144
- Testing
- Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)
- Where
- Finland
- Volunteers
- 12 people
- Sponsor
- Medtentia International Ltd Oy
Mitral Valve Insufficiency, Mitral Valve Regurgitation
Feasibility Study of a Percutaneous Mitral Valve Repair System.
Prospective, multi-center, Phase I study of the Evalve Cardiovascular Valve Repair System (CVRS) in the treatment of mitral valve regurgitation. Patients will undergo 30-day, 6 month, 12 month, and 5 year clinical follow-up.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation
- Trial name
- EVEREST(I) (NCT00209339)
- Testing
- Percutaneous mitral valve repair (MitraClip Implant)
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- Abbott Medical Devices
Mitral Valve Insufficiency, Mitral Valve Regurgitation
Real World Expanded Multicenter Study of the MitraClip® System (REALISM)
Prospective, multicenter, continued access registry of the MitraClip® Cardiovascular Valve Repair System in the treatment of mitral valve regurgitation.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation
- Trial name
- REALISM (NCT01931956)
- Testing
- MitraClip® implant
- Where
- 38 sites in United States
- Volunteers
- 965 people
- Sponsor
- Abbott Medical Devices
Mitral Valve Regurgitation, Mitral Valve Prolapse
CE Mark Study for the Harpoon Medical Device
The purpose of this study is to evaluate the safety and performance of the Harpoon Medical device. It is anticipated, that the Harpoon Medical device will provide advantages over current surgical interventions including: 1) a…
- Conditions
- Mitral Valve Regurgitation, Mitral Valve Prolapse, Mitral Valve Insufficiency
- Trial name
- TRACER (NCT02768870)
- Testing
- Harpoon Artificial ePTFE Chords
- Where
- 4 sites in Italy, United Kingdom
- Volunteers
- 26 people
- Sponsor
- Edwards Lifesciences
Mitral Regurgitation
MitraClip System in Australia and New Zealand
The primary objective of the MitraClip System Australia and New Zealand (ANZ) Clinical Trial is to gather real-world clinical and health-economic outcome data to support the long-term safety, efficacy and economic value of the…
- Trial name
- MitraClipANZ (NCT01301625)
- Testing
- MitraClip Implant
- Where
- 6 sites in Australia
- Volunteers
- 78 people
- Sponsor
- Abbott Medical Devices