Clinical trials: Bicuspid Valve Disorder
AORTIC VALVE DISEASES, Mitral Valve Failure
Advanced Robotic Beds for the Early Rehabilitation of Cardiac Surgery Patients
The goal of this clinical trial is to evaluate whether LOLE.K, a new and specialized robotic bed, is effective in the rehabilitation of patients who have undergone surgery.
- Trial name
- CARE (NCT07273669)
- Testing
- use of the robotic bed
- Where
- Italy
- Volunteers
- 20 people
- Sponsor
- University of Salerno
Aneurysm Aortic, Aneurysm Aortic Root
Strength Tracking From Wall Tichness Over Aortic Biomechanics (STORM)
The aim of the study is to analyse the resected portion of aneurysmatic ascending aorta in order to assess its strength to rupture, standardise the various measurements performed within the lab and try to correlate these…
- Trial name
- STORM (NCT07453251)
- Where
- Italy
- Volunteers
- 40 people
- Sponsor
- IRCCS Policlinico S. Donato
Functional Mitral Regurgitation, Heart Failure
The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With FMR
The objective of this prospective, randomized, double- blinded (patient and assessors), sham-controlled clinical trial is to assess the safety and efficacy of the CMCS in treating heart failure with functional regurgitation (FMR).
- Conditions
- Functional Mitral Regurgitation, Heart Failure, Mitral Valve Insufficiency, Heart Diseases
- Trial name
- NCT03142152
- Testing
- Carillon Mitral Contour System, Guideline Directed Heart Failure Medication
- Where
- 92 sites in United States, Canada and 6 more
- Volunteers
- 300 people
- Sponsor
- Cardiac Dimensions, Inc.
Bicuspid Aortic Valve, Unicuspid Aortic Valve
Genetic Risks for Bicuspid Aortic Valve Disease
Bicuspid Aortic Valve (BAV) is the most common congenital heart malformation in adults, but very little is known about the genetic causes or risk factors for adverse outcomes.
- Trial name
- NCT01823432
- Where
- United States
- Volunteers
- 454 people
- Sponsor
- The University of Texas Health Science Center, Houston
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 Regurgitation
MitraClip® After Surgical Mitral Valve Repair
Percutaneous edge-to-edge repair of the mitral valve has been shown to be a safe and effective alternative treatment option for selected patients at high risk for cardiac surgery.
- Trial name
- MVRepair (NCT02853955)
- Testing
- Percutaneous edge-to-edge repair of the mitral valve
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- LMU Klinikum
Aortic Stenosis, Mitral Regurgitation
Treatment of Concomitant Mitral Regurgitation by Mitral Valve Clipping in Patients With Successful Transcatheter Aortic Valve Implantation.
To evaluate whether patients after successful transfemoral transcatheter aortic valve implantation (TAVI), who have concomitant, moderate to severe mitral regurgitation (MR) benefit from an additional treatment of this valve…
- Trial name
- MITAVI (NCT04009434)
- Testing
- Mitral Valve Clipping, TAVI
- Where
- Germany
- Volunteers
- 1,162 people
- Sponsor
- Technische Universität Dresden
Mitral Valve Prolapse, Mitral Plasty
Prognostic Impact of the Location of Mitral Valve Prolapse on the Long-term Results of Mitral Plasty
Mitral insufficiency (MI) accounts for 24% of adult valvulopathies and affects 7% of subjects older than 75 years. They are the second leading cause of valvulopathy in Europe.
- Trial name
- IPPVM (NCT03113552)
- Where
- France
- Volunteers
- 1,500 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Mitral Valve Stenosis
Late Clinical Outcomes of Percutaneous Mitral Commissurotomy in Patients With Mitral Stenosis
In this retrospective cohort study, out of 220 patients who had undergone successful PTMC between 2006 and 2018, the clinical course of 186 patients could be successfully followed.
- Trial name
- NCT04112108
- Testing
- PTMC
- Where
- Iran
- Volunteers
- 220 people
- Sponsor
- Shiraz University of Medical Sciences
Degenerative Mitral Valve Disease, Mitral Valve Regurgitation
Chordal Repair for Transcatheter Mitral Valve Repair (TMVr)
A multi-center evaluation of the Pipeline chordal repair system for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve repair.
- Trial name
- NCT04281940
- Testing
- Transcatheter implantation of chordal repair system
- Where
- 4 sites in Georgia, Paraguay and 1 more
- Volunteers
- 7 people
- Sponsor
- Pipeline Medical
Heart Disease, Mitral Regurgitation
Using Beta Blockers to Treat Mitral Regurgitation
The purpose of this study tests whether beta-blocker will benefit asymptomatic patients with chronic primary mitral regurgitation.
- Conditions
- Heart Disease, Mitral Regurgitation, Heart Valve Disease, Mitral Valve Insufficiency
- Trial name
- REGURG (NCT00700947)
- Testing
- Beta-blocker therapy (TOPROL-XL® )
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Wake Forest University Health Sciences
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
The Papillary Muscle Approximation Provide Stability of Mitral Valve Repair for Ischemic Mitral Regurgitation
Recent publications show that an adjunctive subvalvular repair during mitral annuloplasty for secondary mitral regurgitation effective in preventing recurrent regurgitation.
- Trial name
- PMA (NCT03038204)
- Testing
- The papillary muscle approximation
- Volunteers
- 100 people
- Sponsor
- The Federal Centre of Cardiovascular Surgery, Russia
Mitral Valve Regurgitation, Mitral Valve Prolapse
CE Mark Study for the Harpoon Medical Device in Poland
The purpose of this study is to evaluate the safety and performance of the Harpoon Medical TSD-5. The Harpoon device will provide many significant advantages over current surgical interventions including: 1) a small minimally…
- Conditions
- Mitral Valve Regurgitation, Mitral Valve Prolapse, Mitral Valve Insufficiency
- Trial name
- NCT02432196
- Testing
- Harpoon Medical Device
- Where
- 2 sites in Poland
- Volunteers
- 26 people
- Sponsor
- Edwards Lifesciences
Mitral Valve Prolapse
Myocardial Characterization of Arrhythmogenic Mitral Valve Prolapse (STAMP: STretch and Myocardial Characterization in Arrhythmogenic Mitral Valve Prolapse)
Mitral valve prolapse (MVP) is a frequent affection of the mitral valve or its sub-valvular apparatus with a prevalence of 2-3% in the general population.
- Trial name
- STAMP (NCT02879825)
- Testing
- Cardiac MRI
- Where
- France
- Volunteers
- 239 people
- Sponsor
- Central Hospital, Nancy, France
Mitral Regurgitation, Mitral Valve Disease
ALLIANCE Mitral: Safety and Effectiveness of SAPIEN X4 Transcatheter Heart Valve - Mitral
This study will establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects who are at high or greater surgical risk with a failing mitral surgical bioprosthetic valve or a failing…
- Conditions
- Mitral Regurgitation, Mitral Valve Disease, Mitral Stenosis
- Trial name
- NCT06167213
- Testing
- SAPIEN X4 THV
- Volunteers
- 125 people
- Sponsor
- Edwards Lifesciences
Bicuspid-related Aortopathy, Aortic Stenosis
PRogression Of bicuSPid-rElated aoRtOpathy in Patients Undergoing Transcatheter Aortic Valve Implantation (PROSPERO-TAVI)
Transcatheter aortic valve implantation (TAVI) is being offered to younger patients affected by severe aortic stenosis as an alternative to surgery.
- Trial name
- PROSPERO-TAVI (NCT06248294)
- Testing
- CT follow-up
- Where
- Italy
- Volunteers
- 300 people
- Sponsor
- University of Catania
Hypertrophic Cardiomyopathy
Mitral Valve Management During Septal Myectomy
Objective of the study: to evaluate whether alfieri technique improves clinical and hemodynamic results compared to transaortic mitral valve secondary cord cutting in patients scheduled to septal myectomy for severely symptomatic…
- Trial name
- MVMSM (NCT03906734)
- Testing
- Septal myectomy, alfieri stich, Subvalvular intervention
- Where
- Russia
- Volunteers
- 48 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Degenerative Mitral Valve Disease, Mitral Regurgitation
Long Term Results of Surgical and Percutaneous Double Orefices Mitral Repair in Patient With p2 Prolapse Causing Degenerative Mitral Regurgitation
Mitral regurgitation is a pathology affecting the left atrioventricular valve that causes a volumetric and pressure overload in the left chambers due to the loss of unidirectionality normally guaranteed by the cardiac valve…
- Trial name
- NCT05836532
- Testing
- Central edge-to-edge
- Where
- Italy
- Volunteers
- 110 people
- Sponsor
- Michele De Bonis
Mitral Valve Regurgitation (Degenerative or Functional)
TVMR With the Innovalve System Trial - Pilot Study in Italy
Study to evaluate the safety and performance of the Innovalve mitral valve replacement system
- Trial name
- TWIST-PILOT-IT (NCT05010746)
- Testing
- Innovalve TMVR system
- Where
- Italy
- Volunteers
- 4 people
- Sponsor
- Edwards Lifesciences