Clinical trials: Valve Regurgitation, Mitral
Mitral Regurgitation, Atrial Fibrillation (AF)
Study for the Identification of Subclinical Atrial Fibrillation In Patients With Significant Primary Mitral Regurgitation
The PRIME-LOOP study is a prospective cohort investigating the burden of atrial fibrillation (AF) and subclinical AF in patients with moderate-severe or severe primary mitral regurgitation (MR).
- Trial name
- PRIME-LOOP (NCT07377799)
- Where
- Denmark
- Volunteers
- 100 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
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
Residual Mitral Regurgitation
Multiparametric Protocol for Assessment of Intraprocedural Result of MITRACLIP Procedure
Quantification of residual mitral regurgitation (MR) after MitraClip may be challenging. Quantitative methods for severity assessment may be inaccurate and recent recommendations suggest an assessment of changes in both…
- Trial name
- IPCLIP-2020 (NCT06184789)
- Testing
- Echocardiographic assessment
- Where
- Italy
- Volunteers
- 80 people
- Sponsor
- IRCCS San Raffaele
Mitral Valve Failure
NHLBI DIR LAMPOON Study: Intentional Laceration of the Anterior Mitral Leaflet to Prevent Left Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Implantation
Background: Transcatheter mitral valve replacement (TMVR) is recommended for some people with mitral valve heart problems. But the usual TMVR techniques might cause an obstruction for some people.
- Trial name
- NCT03015194
- Testing
- Edwards SAPIEN 3 transcatheter heart valve, ASHI INTECC Astato XS 20
- Where
- 6 sites in United States
- Volunteers
- 32 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Mitral Regurgitation
Flexible Band vs Rigid Ring for Degenerative Mitral Valve Disease
The study evaluates the results of mitral valve repair with flexible band in comparison with rigid ring in patients undergoing mitral valve repair for degenerative mitral valve disease
- Trial name
- NCT03278574
- Testing
- Mitral valve repair, Ring annuloplasty with posterior band, Ring annuloplasty with complete ring
- Volunteers
- 171 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Valvular Heart Disease
Multicenter Registry Study of Aortic Valve Stenosis in Zhejiang Elderly（Mrs AVS）
Aortic valve stenosis (AVS) is becoming more and more frequent with the aging, which has brought a heavy burden to the world. However, the prevalence and prognosis of valvular heart disease are not so clear, especially in the…
- Trial name
- NCT03797820
- Testing
- Our study type is observational
- Where
- China
- Volunteers
- 1 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Mitral Insufficiency
Assessing the Relationship Between Symptoms and Mitral Regurgitnant. Severity
The current American College of Cardiology/American Heart Association (ACC/AHA) guidelines recommend surgery in patient with mitral regurgitation (MR) based on 1) the severity of MR and 2) the presence or absence of symptoms.
- Trial name
- NCT06738615
- Testing
- Pressure volume loop evaluation, cardiovascular magnetic resonance imaging, Cardiopulmonary exercise testing (CPET)
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Atlantic Health System
Mitral Valve Prolapse
St. Jude Medical Percutaneous Mitral Valve Repair Study
The purpose of this proof-of-concept study is to assess the relative safety and feasibility of the SJM Percutaneous Mitral Valve Repair (PMVr) Device.
- Trial name
- SJM PMVr (NCT01500148)
- Testing
- PMVr procedure (SJM Percutaneous Mitral Valve Repair (PMVr)
- Where
- United Kingdom
- Volunteers
- 2 people
- Sponsor
- Abbott Medical Devices
Mitral Valve Insufficiency
High and Intermediate Risk Degenerative Mitral Regurgitation Treatment: A Trial Comparing MitraClip® to Surgical Therapy
The study is comparing MitraClip® to Surgical therapy in high and intermediate risk patients, who should be older than 18 years, and shall evaluate safety and efficacy of MitraClip® vs.
- Trial name
- HiRiDe (NCT02534155)
- Testing
- MitraClip®, Mitral valve Surgery
- Where
- 12 sites in Germany, Italy and 1 more
- Volunteers
- 294 people
- Sponsor
- University of Zurich
Heart Failure, Mitral Regurgitation
Study of Safety and Efficacy of the Percutaneous Reduction of Mitral Valve Regurgitation in Heart Failure Patients
Improvement in heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implantable device.
- Trial name
- PTOLEMY-2 (NCT00787293)
- Testing
- PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant
- Where
- 13 sites in Belgium, Czechia and 3 more
- Volunteers
- 30 people
- Sponsor
- Viacor
Mitral Valve Insufficiency, Left Ventricular Dysfunction
Pharmacological Reduction of Functional, Ischemic Mitral REgurgitation
Functional MR is caused by adverse left ventricular remodeling after myocardial injury and associated with an increased incidence of heart failure and death.
- Trial name
- PRIME (NCT02687932)
- Testing
- LCZ696, Valsartan
- Where
- 4 sites in South Korea
- Volunteers
- 118 people
- Sponsor
- Asan Medical Center
Mitral Valve Insufficiency, Mitral Valve Regurgitation
Pivotal Study of a Percutaneous Mitral Valve Repair System
EVEREST II Randomized Controlled Trial (RCT) is a prospective, multi-center, randomized study of the MitraClip® System in the treatment of mitral valve regurgitation, randomizing patients to MitraClip or mitral valve surgery.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation
- Trial name
- EVERESTIIRCT (NCT00209274)
- Testing
- Percutaneous mitral valve repair using MitraClip implant, Mitral valve repair or replacement surgery
- Where
- United States
- Volunteers
- 279 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Insufficiency, Aortic Valve Regurgitation
Aortic or Mitral Valve Replacement With the Braile Biomédica® Bovine Pericardium Valvular Bioprosthesis
Collect data on the safety and clinical performance of the Braile Biomédica® Bovine Pericardium Valvular Bioprosthesis
- Conditions
- Aortic Valve Insufficiency, Aortic Valve Regurgitation, Aortic Valve Stenosis, Aortic Valve Incompetence
- Trial name
- NCT05902897
- Testing
- Braile Biomédica® Bovine Pericardium Valvular Bioprosthesis.
- Where
- 3 sites in Brazil
- Volunteers
- 913 people
- Sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda.
Mitral Regurgitation, Mitral Valve Regurgitation
Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (The COAPT Trial) and COAPT CAS
The purpose of the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) Trial is to confirm the safety and effectiveness of the MitraClip…
- Conditions
- Mitral Regurgitation, Mitral Valve Regurgitation, Treatment of Functional Mitral Regurgitation in Symptomatic Heart Failure Subjects, Heart Failure
- Trial name
- COAPT (NCT01626079)
- Testing
- MitraClip System
- Where
- 86 sites in United States, Canada
- Volunteers
- 776 people
- Sponsor
- Abbott Medical Devices
Heart Valve Diseases, Mitral Valve Insufficiency
Normal Values in Stress Echocardiographic Parameters in Patients After Successful Mitral Valve Repair for Organic MR
Surgical treatment is the only approach with potentially defined clinical success for organic mitral valve (MV) regurgitation. Recurrent or persistent complaints after initial successful MV repair is a clinical challenge in…
- Conditions
- Heart Valve Diseases, Mitral Valve Insufficiency, Heart; Dysfunction Postoperative, Cardiac Surgery, Heart; Disease, Mitral(Valve)
- Trial name
- SEP (NCT02371863)
- Where
- Netherlands
- Volunteers
- 25 people
- Sponsor
- UMC Utrecht
Mitral Insufficiency, Mitral Stenosis
Polish Transcatheter Transfemoral Mitral Valve-in-Valve Implantation (Mitral ViV) Registry
In recent years increasing number of mitral bioprosthesis implantation, especially in elderly population, is observed. Bioprosthetic valves are associated with a lower risk of thrombotic and bleeding adverse events compared with…
- Conditions
- Mitral Insufficiency, Mitral Stenosis, Mitral Stenosis With Insufficiency, Heart Failure
- Trial name
- NCT05625607
- Testing
- Transcatheter mitral valve-in-valve implantation
- Where
- 7 sites in Poland
- Volunteers
- 100 people
- Sponsor
- Medical University of Warsaw
Mitral Regurgitation, Mitral Valve Insufficiency
The ENCIRCLE Trial
This study will establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are…
- Trial name
- ENCIRCLE (NCT04153292)
- Testing
- SAPIEN M3 valve and dock
- Where
- 54 sites in United States, Australia and 4 more
- Volunteers
- 786 people
- Sponsor
- Edwards Lifesciences
Mitral Regurgitation, Coronary Artery Disease
Randomised Ischaemic Mitral Evaluation (RIME) Trial
The study is a randomised controlled trial comparing two treatment strategies for patients with moderate functional ischaemic mitral regurgitation undergoing coronary artery bypass grafting (CABG).
- Trial name
- RIME (NCT00413998)
- Testing
- CABG + Mitral valve annuloplasty, CABG
- Where
- 9 sites in Poland, United Kingdom
- Volunteers
- 73 people
- Sponsor
- Imperial College London
Mitral Regurgitation
SQ-Kyrin TMVr FIM Study
A feasibility study to evaluate the effectiveness and safety of the SQ-Kyrin Transcatheter Edge-to-Edge Valve Repair System for the treatment of moderate-to-severe mitral regurgitation in patients with high surgical risk.
- Trial name
- NCT05040074
- Testing
- SQ-Kyrin Transcatheter Edge-to-Edge Valve Repair System
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Shanghai Shenqi Medical Technology Co., Ltd
Mitral Regurgitation, Mitral Valve Disease
Evaluation of Mitral Valve Insufficiency Under General Anesthesia
Observational study in adult humans undergoing surgical or cardiological intervention for mitral valve insufficiency. Investigators aim to evaluate hemodynamic changes on an arterial pressure waveform level in patients before and…
- Conditions
- Mitral Regurgitation, Mitral Valve Disease, Mitral Valve Insufficiency
- Trial name
- MITIGATE (NCT05736289)
- Where
- Netherlands
- Volunteers
- 50 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)