Clinical trials: Mitral Valve Failure
Cardiomyopathy, Cardiovascular Diseases
Improving Mitral Repair for Functional Mitral Regurgitation
The investigators are interested in determining the best surgical technique to correct functional mitral regurgitation, as there is currently not one technique that is established to work better than the other.
- Conditions
- Cardiomyopathy, Cardiovascular Diseases, Congestive Heart Failure, Coronary Artery Disease
- Trial name
- IMPROVE-FMR (NCT03366649)
- Testing
- Undersizing Mitral Annuloplasty, Papillary Muscle Approximation
- Where
- 3 sites in United States
- Volunteers
- 34 people
- Sponsor
- Emory University
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.
Mitral Regurgitation, Heart Failure
Strain Imaging in Patients With Functional Mitral Regurgitation, Treated With MitraClip
The aim of this study is i) to evaluate left ventricular global longitudinal strain and myocardial work in patients with heart failure and severe functional mitral regurgitation one year after MitraClip implantation and compare…
- Trial name
- NCT04218578
- Testing
- speckle tracking analysis of transthoracic echocardiogram
- Where
- Greece
- Volunteers
- 100 people
- Sponsor
- University of Athens
Cardiovascular Diseases
A Randomized Study of the MitraClip Device in Heart Failure Patients With Clinically Significant Functional Mitral Regurgitation
This trial is a randomized study of the MitraClip device in heart failure patients with clinically significant functional mitral regurgitation.
- Trial name
- RESHAPE-HF (NCT01772108)
- Testing
- MitraClip
- Where
- 29 sites in Austria, Belgium and 8 more
- Volunteers
- 42 people
- Sponsor
- Abbott Medical Devices
Mitral Regurgitation, Heart Failure
MitraClip for the Treatment of Moderate Functional Mitral Regurgitation: EVOLVE-MR
This study evaluates the addition of transcatheter mitral valve repair with the MitraClip device to medical treatment in patients with heart failure and moderate functional mitral regurgitation to determine the impact of left…
- Conditions
- Mitral Regurgitation, Heart Failure, Mitral Valve Regurgitation Due to Cardiomyopathy (Disorder)
- Trial name
- EVOLVE-MR (NCT03705312)
- Testing
- Transcatheter mitral valve repair, Guideline-directed medical therapy
- Where
- Canada
- Volunteers
- 174 people
- Sponsor
- Montreal Heart Institute
Heart Failure With Reduced Ejection Fraction, Mitral Regurgitation
The CardioClip Study
The CardioClip study is exploring the use of a wireless sensor to monitor pressure in the pulmonary artery. This sensor is inserted much like the mTEER procedure, a non-surgical method through a vein in the groin.
- Trial name
- CardioClip (NCT06241430)
- Testing
- CardioMEMS
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Columbia University
Heart Failure, Cardiomyopathy, Dilated
Early Feasibility Study of the AccuCinch® Ventricular Restoration System in Patients With Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation
This is a non-randomized, prospective, multi-center Early Feasibility Study of the AccuCinch® Ventricular Restoration System in Patients with Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation.
- Trial name
- CorCinch-PMVI (NCT03560167)
- Testing
- AccuCinch® Ventricular Restoration System
- Where
- 19 sites in United States
- Volunteers
- 5 people
- Sponsor
- Ancora Heart, Inc.
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
Mitral Regurgitation, Heart Failure
Safety and Efficacy Study of the PTMA Device to Reduce Mitral Valve Regurgitation in Patients With Heart Failure
Improvement in heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implantable device residing in the coronary sinus
- Trial name
- PTOLEMY2Canada (NCT00815386)
- Testing
- Percutaneous transvenous mitral annuloplasty
- Where
- 3 sites in Canada
- Volunteers
- 20 people
- Sponsor
- Viacor
Mitral Insufficiency, Mitral Regurgitation (MR)
MItral Regurgitation Risk Assessment and CLinical modElling
Mitral regurgitation (MR) is a common valvular heart disease worldwide, and untreated severe MR is associated with an elevated risk of heart failure and mortality.
- Trial name
- MIRACLE (NCT06876883)
- Where
- China
- Volunteers
- 2,000 people
- Sponsor
- Sun Yat-sen University
Bioprosthesis Failure, Mitral Stenosis With Insufficiency
The China Mviv Registry
Mitral valve disease is the most common structure heart disease, and surgical valve replacement is an important treatment for severe mitral valve disease.
- Conditions
- Bioprosthesis Failure, Mitral Stenosis With Insufficiency, Mitral Stenosis, Mitral Regurgitation
- Trial name
- NCT05925335
- Testing
- Transseptal Transcatheter Mitral valve-in-valve Replacement
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Xiamen Cardiovascular Hospital, Xiamen University
Mitral Valve Insufficiency, Mitral Valve Disease
The Conveyor Study
To demonstrate that the Conveyor System can safely provide left ventricular access to deliver the SAPIEN 3 (Edwards Lifesciences, Irvine, California) transcatheter heart valve in patients who have been diagnosed with prior mitral…
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Disease, Mitral Valve Regurgitation, Heart Failure
- Trial name
- NCT03893578
- Testing
- Mitral valve-in-valve
- Volunteers
- 10 people
- Sponsor
- Synecor, LLC
Ventricular Remodeling, Left
Transcatheter Mitral Valve Repair for the Treatment of Mitral Valve Regurgitation In Heart Failure (The EVOLVE-MR Trial)
The study compares the effectiveness of treatment with MitraClip to medical therapy in improving the reduction of cardiovascular morbidity and functional capacity at 24 months, in patients with moderate functional mitral…
- Trial name
- EVOLVE-MR (NCT03891823)
- Testing
- MitraClip, Medical Therapy
- Where
- Canada
- Volunteers
- 9 people
- Sponsor
- Montreal Heart Institute
Heart Failure, Mitral Regurgitation
Aachen Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device to Reduce Mitral Regurgitation
Improvement in heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implanted device
- Trial name
- PTOLEMY (NCT00572091)
- Testing
- PTMA Implant
- Where
- Germany
- Volunteers
- 4 people
- Sponsor
- Viacor
Mitral Regurgitation
Structural Mitral Valve Project
This is a prospective Quality Improvement (QI) study using the Model for Improvement framework. The objective of this study is to implement a structured, comprehensive, innovative, and sustainable approach to the management of…
- Trial name
- NCT05678868
- Testing
- MitraClip procedure
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- Queen's University
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, Mitral Valve Disease
LEFT ATRIAL MONITORING IN PATIENTS BEFORE AND AFTER MITRAL SURGERY - LAMBDA STUDY
Mitral valve leakage, or mitral regurgitation (MR), is associated with heart failure symptoms including shortness of breath, fatigue, irregular heart rate. When left untreated, it may cause death.
- Conditions
- Mitral Regurgitation, Mitral Valve Disease, Heart Failure
- Trial name
- LAMBDA (NCT06547788)
- Testing
- Mitral valve repair with creation of an 8 mm inter-atrial shunt
- Where
- Canada
- Volunteers
- 50 people
- Sponsor
- Ottawa Heart Institute Research Corporation
Functional Mitral Regurgitation
Percutaneous Left Ventricular Reshaping to Reduce Functional Mitral Regurgitation and Improve LV Function
The study is designed to demonstrate the safety, feasibility and potential efficacy of using the AccuCinch® System to reduce functional mitral regurgitation.
- Trial name
- LVRESTORESA (NCT01899573)
- Testing
- AccuCinch® Ventriculoplasty System
- Where
- Colombia
- Volunteers
- 8 people
- Sponsor
- Ancora Heart, Inc.
Cardiovascular Diseases
Effectiveness and Safety of Mitral Valve Repair With the NeoChord DS1000 Artificial Chordae Delivery System Versus Conventional Surgery in Patients With Severe Primary Mitral Regurgitation Due to Isolated Leaflet Prolapse
The main objective is to assess the effectiveness and safety of the NeoChord DS1000 repair technique as compared with conventional open-heart on-pump mitral valve surgery in patients with severe primary mitral regurgitation.
- Trial name
- MITRACHORD (NCT02829749)
- Testing
- NeoChord beating heart mitral valve implantation, Control
- Where
- France
- Sponsor
- Hospices Civils de Lyon
Atrial Functional Mitral Regurgitation
Safety and Efficacy of Transcatheter Edge-to-Edge Repair for Atrial Functional Mitral Regurgitation
This study is a prospective, randomized, parallel-control, open-label, multicenter clinical trial. Eligible subjects will be randomized in a 1:1 ratio to the Device group (Interventional group) or to no Device group (Control…
- Trial name
- STAR (NCT07414225)
- Testing
- Transcatheter Edge-to-Edge Repair, Guideline-Directed Medical Therapy (GDMT) for cardiovascular disease
- Where
- China
- Volunteers
- 400 people
- Sponsor
- Beijing Anzhen Hospital