Clinical trials: Mitral Regurgitation
Heart Failure
Reduction of Mitral Regurgitation With the SATURN Trans-Septal Transcatheter Mitral Valve Replacement (TMVR) System in Patients With Severe Symptomatic Mitral Regurgitation
The goal of this clinical trial is to evaluate feasibility, safety, and performance of the SATURN TS TMVR System for the treatment of moderate-to-severe or severe, symptomatic mitral regurgitation through a transcatheter…
- Trial name
- CASSINI-EU (NCT06414265)
- Testing
- Transcatheter mitral valve replacement
- Where
- 8 sites in Georgia, Italy and 3 more
- Volunteers
- 30 people
- Sponsor
- InnovHeart
Mitral Valve Regurgitation, Mitral Valve Insufficiency
HighLife™ Transcatheter Mitral Valve Replacement System Study
Multicenter feasibility study of the HighLife™ TMVR system.
- Trial name
- NCT02974881
- Testing
- Transcatheter Mitral Valve Replacement
- Where
- 10 sites in France, Germany
- Volunteers
- 5 people
- Sponsor
- HighLife SAS
Functional Mitral Regurgitation
Early Feasibility Study of the PLAR Implant and Delivery System to Treat Functional Mitral Regurgitation ( EXPLORE FMR )
An early feasibility study to evaluate the safety and feasibility of the PLAR Implant and Delivery System to treat severe functional mitral regurgitation and to gather preliminary data on its performance thereby providing…
- Trial name
- EXPLORE FMR (NCT04666467)
- Testing
- Transcatheter mitral valve repair
- Where
- United States
- Sponsor
- Polares Medical SA
Mitral Regurgitation, Mitral Insufficiency
Edwards Cardioband European Post-Market Study, MiBAND
To demonstrate reduction of MR with durable performance and im-provements in functional status
- Conditions
- Mitral Regurgitation, Mitral Insufficiency, Mitral Repair, Mitral Valve
- Trial name
- MiBAND (NCT03600688)
- Testing
- Edwards Cardioband System
- Where
- 17 sites in Germany, Italy and 1 more
- Volunteers
- 200 people
- Sponsor
- Edwards Lifesciences
Acute Ischemic Stroke
Imaging Guided Patient Selection for Interventional Revascularization Therapy
The primary objective of this clinical evaluation is to determine the safety and effectiveness of the Penumbra System in a stroke cohort who presents within 8 hours from symptom and with a known core infarct volume at admission.
- Trial name
- START (NCT00963989)
- Testing
- Penumbra System
- Where
- United States
- Volunteers
- 146 people
- Sponsor
- Penumbra Inc.
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
Mitral Valve Regurgitation
Expanded Clinical Study of the Tendyne Mitral Valve System
The purpose of this study is to evaluate the safety and performance of the Tendyne Mitral Valve System in the treatment of severe mitral regurgitation in patents with functional disability greater than or equal to NYHA Class II…
- Trial name
- NCT02321514
- Testing
- Tendyne Mitral Valve System
- Where
- 40 sites in United States, Australia and 8 more
- Volunteers
- 191 people
- Sponsor
- Abbott Medical Devices
Degenerated Mitral Regurgitation
Safety and Effectiveness Study of SQ-Kyrin TMVr System for Degenerated 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.in patients with moderate-severe or severe degenerated…
- Trial name
- NCT06467110
- Testing
- transcatheter mitral valve clip delivery system and steerable guide catheter (Shenqi Medical)
- Where
- China
- Volunteers
- 118 people
- Sponsor
- Shanghai Shenqi Medical Technology Co., Ltd
Mitral Regurgitation, Mitral Insufficiency
ATLAS (AltaValve) Pivotal Trial
This is a prospective, single arm, multicenter, clinical trial designed to evaluate the safety and performance of the AltaValve System for the treatment of mitral regurgitation in a targeted patient population.
- Conditions
- Mitral Regurgitation, Mitral Insufficiency, Mitral Valve Incompetence, Mitral Valve Regurgitation
- Trial name
- ATLAS (NCT06465745)
- Testing
- AltaValve System.
- Where
- 58 sites in United States, Canada and 5 more
- Volunteers
- 450 people
- Sponsor
- 4C Medical Technologies, Inc.
Mitral Regurgitation, Mitral Insufficiency
AltaValve Early Feasibility Study Protocol
Prospective, single-arm, multicenter study to evaluate the safety and performance of the AltaValve for the treatment of moderate to severe or severe mitral valve regurgitation in subjects who are considered high risk for…
- Conditions
- Mitral Regurgitation, Mitral Insufficiency, Mitral Valve Incompetence, Mitral Valve Regurgitation
- Trial name
- NCT03997305
- Testing
- AltaValve
- Where
- 12 sites in United States
- Volunteers
- 15 people
- Sponsor
- 4C Medical Technologies, Inc.
Mitral Regurgitation
Capstan Medical TMVR Study: FIH
This study is a prospective, multi-center, non-randomized first in human study to evaluate the safety and feasibility of the Capstan Medical TMVR System for intervention in adults with moderate-severe or greater mitral…
- Trial name
- NCT06600191
- Testing
- Capstan System transcatheter mitral valve replacement
- Where
- 4 sites in Australia, Brazil and 2 more
- Volunteers
- 10 people
- Sponsor
- Capstan Medical
Mitral Regurgitation
Cardiovalve Transfemoral System - FIM Study
The Cardiovalve system is a replacement valve delivered through a transfemoral access and transseptal approach and is intended for symptomatic patients with Mitral regurgitation for whom surgical options are not feasible.
- Trial name
- NCT03958773
- Testing
- Cardiovalve transfemoral Mitral valve system
- Where
- Lithuania
- Volunteers
- 10 people
- Sponsor
- Cardiovalve Ltd.
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.
Mitral Valve Regurgitation of Any Grade
Mitral Valve Regurgitation Quantification From 3D Color Doppler Ultrasound - Standard of Care Data Collection
The study primarily aims to collect standard of care clinical data in a wide spectrum of simple to complex mitral valve regurgitation (MVR) cases to validate a post-processing stand-alone software prototype (QFlow), developed by…
- Trial name
- NCT03286088
- Testing
- TransEsophageal Echocardiography and TransEsophageal Echocardiography, Cardiac Magnetics Resonance, MitraClip
- Where
- Belgium
- Volunteers
- 120 people
- Sponsor
- Philips Clinical & Medical Affairs Global
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
Degenerative Mitral Valve Disease
Early Feasibility Study of the PLAR Implant and Delivery System to Treat Degenerative Mitral Regurgitation
An early feasibility study to evaluate the safety and feasibility of the PLAR Implant and Delivery System to treat severe degenerative mitral regurgitation and to gather preliminary data on its performance thereby providing…
- Trial name
- EXPLORE DMR (NCT04666480)
- Testing
- Transcatheter mitral valve repair
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Polares Medical SA
Congestive Heart Failure, Ischemic Cardiomyopathy
Cardiac Output Pulmonary Arterial Catheter Compared to FloWave™ 1000
The purpose of this study is to compare cardiac output results obtained using the thermodilution push technique with the Pulmonary Arterial Catheter (PAC) to the predicted cardiac output results obtained from the non-invasive…
- Conditions
- Congestive Heart Failure, Ischemic Cardiomyopathy, Mitral Valve Prolapse, Mitral Regurgitation
- Trial name
- NCT00665301
- Where
- 3 sites in United States
- Volunteers
- 54 people
- Sponsor
- Woolsthorpe Technologies, LLC
Mitral Valve Insufficiency
Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair
The objective of this trial is to assess the safety and effectiveness of the study device in subjects with degenerative mitral valve disease receiving a mitral valve repair without cardiopulmonary bypass (treatment group) when…
- Trial name
- ReChord (NCT02803957)
- Testing
- NeoChord DS1000, Surgical Mitral Valve Repair
- Where
- 14 sites in United States
- Volunteers
- 585 people
- Sponsor
- NeoChord
Functional Mitral Regurgitation, Mitral Regurgitation
Edwards Cardioband System ACTIVE Pivotal Clinical Trial (ACTIVE)
To establish the safety and effectiveness of the Edwards Cardioband System in patients with functional mitral regurgitation (FMR).
- Conditions
- Functional Mitral Regurgitation, Mitral Regurgitation, Mitral Insufficiency
- Trial name
- ACTIVE (NCT03016975)
- Testing
- Edwards Cardioband System, Guideline Directed Medical Therapy
- Where
- 24 sites in United States
- Volunteers
- 12 people
- Sponsor
- Edwards Lifesciences
Mitral Valve Regurgitation (Degenerative or Functional)
Edwards EVOQUE Eos MISCEND Study
Study to evaluate the safety and performance of the Edwards EVOQUE Eos mitral valve replacement system
- Trial name
- NCT02718001
- Testing
- Edwards EVOQUE Eos Mitral Valve Replacement System
- Where
- 19 sites in United States, Canada
- Volunteers
- 123 people
- Sponsor
- Edwards Lifesciences