Clinical trials: Mitral Regurgitation (MR), active
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.
Atrial Functional Mitral Regurgitation, Mitral Insufficiency
Assessment of Transcatheter Edge-to-Edge Repair in Atrial Functional Mitral Regurgitation (ATRIAL-MR)
This investigator-initiated, multicenter, international, retrospective registry aims to investigate outcomes of patients with atrial functional mitral regurgitation, as treated in clinical routine.
- Trial name
- NCT06911099
- Where
- 22 sites in United States, Canada and 4 more
- Volunteers
- 1,000 people
- Sponsor
- University Hospital of Cologne
Mitral Regurgitation (MR)
The Prospective Segeberg Registry for Mitral Transcatheter Edge-to-Edge Repair
A Prospective Follow-up Assessment in Bad Segeberg for Patients with severe MR undergoing M-TEER
- Trial name
- SK M-CLIP (NCT07045753)
- Testing
- Transcatheter edge to edge repair
- Where
- Germany
- Volunteers
- 2,000 people
- Sponsor
- Segeberger Kliniken GmbH
Mitral Valve Regurgitation
MitraClip REPAIR MR Study
The objective of this randomized controlled trial (RCT) is to compare the clinical outcome of MitraClip™ device versus surgical repair in patients with severe primary MR who are at moderate surgical risk and whose mitral valve…
- Trial name
- NCT04198870
- Testing
- MitraClip™ device implantation, Mitral Valve Repair Surgery
- Where
- 74 sites in United States, Canada and 2 more
- Volunteers
- 500 people
- Sponsor
- Abbott Medical Devices
Mitral Regurgitation (MR), Moderate or Severe Aortic Stenosis (AS) (Mean Pressure Gradient ≥ 20 mm Hg or Aortic Valve Area ≤ 1.5 cm2)
Impact of Automatic Prompts in Echocardiographic Reports on Referral to Cardiology
Echo Prompts study is a multi-center randomized controlled study to evaluate the impact of automatic prompts added to the conclusion of the echocardiographic reports of patient diagnosed with significant VHD 1) suggesting…
- Trial name
- Echo Prompts (NCT06816888)
- Testing
- No Prompt, Prompt 1, Prompt 2
- Where
- Canada
- Volunteers
- 300 people
- Sponsor
- Ottawa Heart Institute Research Corporation
Sleep-disordered Breathing (SDB), Aortic Valve Stenosis
Impact of Transcatheter Aortic Valve Implantation and Mitral Valve Repair on Sleep-Disordered Breathing
This prospective observational study aims to investigate the impact of transcatheter aortic valve implantation (TAVI) and transcatheter mitral valve edge-to-edge repair (M-TEER) on sleep-disordered breathing (SDB) in patients…
- Conditions
- Sleep-disordered Breathing (SDB), Aortic Valve Stenosis, Mitral Valve Regurgitation
- Trial name
- SLEEP-VALVE (NCT07520656)
- Where
- Greece
- Volunteers
- 150 people
- Sponsor
- Aristides Plaitis
Mitral Regurgitation
A Clinical Study of GeminiOne TEER System for the Treatment of Severe, Symptomatic MR.
To confirm the effectiveness and safety of the GeminiOne Transcatheter Mitral Valve Repair System for the treatment of severe, symptomatic mitral regurgitation.
- Trial name
- NCT07086534
- Testing
- GeminiOne Transcatheter Edge-to-Edge Repair (TEER) System
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Sierra Valve LLC
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
Functional Mitral Regurgitation
Safety and Effectiveness Study of SQ-Kyrin TMVr System for Functional Mitral Regurgitation
To verify the safety and effectiveness of transcatheter mitral valve clip delivery system and steerable guide catheter produced by Shanghai Shenqi Medical Technology Co., Ltd.
- Trial name
- NCT05988450
- Testing
- SQ-Kyrin Transcatheter Mitral Valve Repair System
- Where
- China
- Volunteers
- 125 people
- Sponsor
- Shanghai Shenqi Medical Technology Co., Ltd
Mitral Regurgitation
HighFLO Study - HighLife Trans-septal Mitral Valve Replacement (TSMVR) Feasibility Study of the Open Cell CLARITY Valve
Feasibility, safety and performance of the HighLife CLARITY TSMV and its delivery system
- Trial name
- HighFLO (NCT04888247)
- Testing
- CLARITY
- Where
- 14 sites in Australia, Belgium and 4 more
- Volunteers
- 30 people
- Sponsor
- HighLife SAS
Glioma
MRS of Glioma Genomics
In France, about 5000 new people with a primary malignant brain tumor are diagnosed each year. The most common primary tumors are gliomas, originating from glial cells (astrocytomas and oligodendrogliomas).
- Trial name
- GLIOMRS (NCT05700071)
- Testing
- MRI
- Where
- 2 sites in France
- Volunteers
- 110 people
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
Mitral Valve Disease
EXPLORE MRace (GE): Early Feasibility Experience of Posterior Leaflet Restoration to Reduce Mitral Regurgitation Using the MRace Implant
An early feasibility study to evaluate the safety and feasibility of the MRace Implant and Delivery System to treat severe mitral regurgitation and to gather preliminary data on its performance thereby providing guidance for…
- Trial name
- EXPLORE_MRace (NCT07796659)
- Testing
- Transcatheter mitral valve repair (MRace Implant and Delivery System)
- Where
- 4 sites in Georgia
- Volunteers
- 100 people
- Sponsor
- Polares Medical SA
Low Back Pain
Examination of Nociscan Impact on Low Back Pain Surgical Outcomes
This study is looking into how useful NOCISCAN is. NOCISCAN is a software as a Service (SaaS) tool that uses Magnetic Resonance (MR) spectroscopy.
- Trial name
- CLARITY (NCT06661850)
- Testing
- Fusion or TDR determined by investigator.
- Where
- 10 sites in United States
- Volunteers
- 300 people
- Sponsor
- Aclarion
Mitral Regurgitation (MR)
Research on the Development and Application of a Preoperative Assessment Model for Transcatheter Mitral Valve Edge-to-Edge Repair Based on Visual Foundation Models
Mitral regurgitation (MR) is the most prevalent valvular heart disease in China. Transcatheter edge-to-edge repair (TEER) is currently the preferred treatment for patients with severe MR who face high surgical risks.
- Trial name
- NCT07247890
- Testing
- Model Construction, Validation, and Optimization
- Volunteers
- 800 people
- Sponsor
- Beijing Hospital
Mitral Regurgitation (MR)
Mitral Valve Repair With the Chord-X System: A Long Term Evaluation
The goal of this clinical trial is to strengthen the evidence available for the Chord-X System by collecting follow-up data from patients who underwent Chord-X implant and to evaluate the long-term safety and performance data…
- Trial name
- METRIX (NCT07413926)
- Testing
- Chord-X system implant
- Where
- 4 sites in United States, Italy and 1 more
- Volunteers
- 110 people
- Sponsor
- Artivion Inc.
Symptomatic Functional MR 3 or Greater
AMEND TS Early Feasibility Study
Valcare Medical AMEND Trans-Septal System is a mitral valve repair annuloplasty ring implanted in a trans-catheter method intended for correction of mitral regurgitation.
- Trial name
- NCT06951672
- Testing
- This study will evaluate the safety and functionality of the AMEND™ Trans-Septal System for annuloplasty as a therapy for mitral regurgitation.
- Where
- 11 sites in United States
- Volunteers
- 15 people
- Sponsor
- Valcare Medical Ltd.
Degenerative Mitral Regurgitation (MR) Due to Leaflet Prolapse
Early Mitral ValvE Repair Versus Watchful Waiting for Asymptomatic SEvere Degenerative Mitral Regurgitation
Degenerative mitral regurgitation (MR) due to leaflet prolapse is frequent and can be surgically repaired in the vast majority of patients.
- Trial name
- REVERSE-MR (NCT03389542)
- Testing
- Surgery, Clinical interview and echocardiography
- Where
- 2 sites in France
- Volunteers
- 424 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Mitral Regurgitation (MR)
Use of Force Feedback Instruments With the da Vinci Surgical System, Model IS5000 for Mitral Valve Repair
This study aims to test the safety and effectiveness of Force Feedback instruments used during robotic-assisted mitral valve repair with the da Vinci Surgical System, Model IS5000 (dV5).
- Trial name
- NCT07655505
- Testing
- Mitral Valve Repair including the use of Force Feedback instruments
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Intuitive Surgical
Mitral Valve (MV) Regurgitation
A Prospective, Multicenter, Single-Arm Study to Support the Clinical Evidence Base for MRace as a Treatment Option for FMR Patients With Complex M-TEER Anatomies (FR)
A pilot study to evaluate the safety and performance of the MRace System to treat severe mitral regurgitation and to gather data on its performance thereby providing guidance for future clinical development.
- Trial name
- ACCESS-MR (FR) (NCT07757607)
- Testing
- Transcatheter mitral valve repair (MRace Implant and Delivery System)
- Volunteers
- 20 people
- Sponsor
- Polares Medical SA
Mitral Regurgitation (MR)
Safety and Feasibility Study of the MitraFix® Transcatheter Mitral Valve System
The goal of this early feasibility clinical trial is to test a new device called the MitraFix® Transcatheter Mitral Valve System.
- Trial name
- MITRA-EFS (NCT07501234)
- Testing
- MitraFix® Transcatheter Mitral Valve System
- Where
- China
- Volunteers
- 5 people
- Sponsor
- Mitrassist Lifesciences Limited Co., Ltd.