Clinical trials: Degenerative Mitral Regurgitation
Mitral Valve Regurgitation (Degenerative or Functional)
TVMR With the Innovalve System Trial - TWIST-BE TWIST-PILOT-BE
Study to evaluate the safety and performance of the Innovalve mitral valve replacement system
- Trial name
- NCT05263375
- Testing
- Innovalve TMVR system
- Sponsor
- Innovalve Bio Medical Ltd.
Mitral Valve Insufficiency, Mitral Valve Prolapse
European FIH Study - NeoChord Transcatheter Mitral Repair System for Symptomatic Mitral Regurgitation
Safety and performance evaluation of the NeoChord Transcatheter Mitral Repair System in patients with degenerative mitral valve regurgitation.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Prolapse, Degenerative, Mitral Regurgitation
- Trial name
- NCT05425628
- Testing
- NeoChord Transcatheter Mitral Repair System (or "NeoChord System")
- Volunteers
- 30 people
- Sponsor
- NeoChord
Degenerative Mitral Regurgitation
CardioFlow Transcatheter Mitral Valve Replacement System Pre-market Clinical Investigation
This is a prospective, multi-center, single-arm study to assess the safety and effectiveness of Microport CardioFlow Transcatheter Mitral Valve Replacement system in the treatment of moderate to severe or severe degenerative…
- Trial name
- NCT07857343
- Testing
- Microport CardioFlow Mitral Valve Replacement System
- Where
- 3 sites in China
- Volunteers
- 152 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Degenerative Mitral Valve Disease, Mitral Regurgitation
Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve…
- Conditions
- Degenerative Mitral Valve Disease, Mitral Regurgitation, Mitral Insufficiency, Functional Mitral Regurgitation
- Trial name
- CLASP IID/IIF (NCT03706833)
- Testing
- Edwards PASCAL System, Abbott Mitraclip System
- Where
- 81 sites in United States, Canada and 2 more
- Volunteers
- 1,247 people
- Sponsor
- Edwards Lifesciences
Mitral Valve Regurgitation (Degenerative or Functional)
Mitral Annular Repair With the CathHELIX™ Transcatheter System in Subjects With FMR
Patients with functional mitral regurgitation classified as moderate to severe (3+) or severe (4+) that are symptomatic (NYHA Class II-IV) will be evaluated for treatment using the CathHELIX Transcatheter Mitral Annuloplasty…
- Trial name
- MARCH (NCT07188233)
- Testing
- Transcatheter Mitral Valve Repair
- Where
- 2 sites in Georgia, Lithuania
- Volunteers
- 5 people
- Sponsor
- HVR Cardio Oy
Degenerative Mitral Valve Disease
EXPLORE DMR: 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
- NCT04679662
- Testing
- Transcatheter mitral valve repair (PLAR Implant and Delivery System)
- Where
- Brazil
- Sponsor
- Polares Medical SA
Mitral Valve Regurgitation (Degenerative or Functional)
TVMR With the INNOVALVE System Trial - Early Feasibility Study
Study to evaluate the safety and performance of the INNOVALVE system
- Trial name
- TWIST-EFS (NCT04919980)
- Testing
- INNOVALVE system
- Where
- 21 sites in United States
- Volunteers
- 85 people
- Sponsor
- Edwards Lifesciences
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
Valveclip® Transcatheter Mitral Valve Repair Study
The purpose of this clinical trial is to evaluate the effectiveness and safety of the transcatheter mitral valve repair system in the treatment of patients with moderate or above degenerative mitral regurgitation.
- Trial name
- NCT05021614
- Testing
- Valveclip® Transcatheter mitral valve repair
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Shanghai NewMed Medical Co., Ltd.
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 Regurgitation, Mitral Valve Prolapse
Safety and Early Feasibility Study of the Harpoon Medical Device (EFS)
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
- EFS (NCT02771275)
- Testing
- Harpoon Medical Device
- Where
- 2 sites in Poland
- Volunteers
- 13 people
- Sponsor
- Edwards Lifesciences
Parkinson's Disease
31P-MRS Imaging to Assess the Effects of CNM-Au8 on Impaired Neuronal Redox State in Parkinson's Disease
REPAIR-PD is a single-center open label pilot, sequential group, investigator and patient blinded study to assess the CNS metabolic effects, safety, pharmacokinetics, and pharmacodynamics of CNM-Au8 in patients who have been…
- Trial name
- REPAIR-PD (NCT03815916)
- Testing
- Gold Nanocrystals
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Clene Nanomedicine
Amyotrophic Lateral Sclerosis
31P-MRS Imaging to Assess the Effects of CNM-Au8 on Impaired Neuronal Redox State in Amyotrophic Lateral Sclerosis (REPAIR-ALS)
REPAIR-ALS is a single-center open label pilot, sequential group, investigator and patient blinded study to assess the CNS metabolic effects, safety, pharmacokinetics, and pharmacodynamics of CNM-Au8 in patients who have been…
- Trial name
- REPAIR-ALS (NCT03843710)
- Testing
- Gold Nanocrystals
- Where
- United States
- Sponsor
- Clene Nanomedicine
Mitral Valve Insufficiency, Mitral Valve Regurgitation
Feasibility Study of a Percutaneous Mitral Valve Repair System.
Prospective, multi-center, Phase I study of the Evalve Cardiovascular Valve Repair System (CVRS) in the treatment of mitral valve regurgitation. Patients will undergo 30-day, 6 month, 12 month, and 5 year clinical follow-up.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation
- Trial name
- EVEREST(I) (NCT00209339)
- Testing
- Percutaneous mitral valve repair (MitraClip Implant)
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- Abbott Medical Devices
Mitral Regurgitation, Mitral Insufficiency
Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation
Prospective, controlled, multicenter clinical investigation with four trial cohorts: Randomized, Non-repairable, Severe Mitral Annular Calcification (MAC) and Severe Mitral Annular Calcification Continued Access Plan (MAC CAP).
- Conditions
- Mitral Regurgitation, Mitral Insufficiency, Mitral Valve Insufficiency, Cardiovascular Diseases
- Trial name
- SUMMIT (NCT03433274)
- Testing
- Tendyne Mitral Valve System, MitraClip System
- Where
- 78 sites in United States, Canada
- Volunteers
- 103 people
- Sponsor
- Abbott Medical Devices
Mitral Valve Regurgitation (Degenerative or Functional)
TVMR With the Innovalve System Trial - Pilot in Georgia
Study to evaluate the safety and performance of the Innovalve mitral valve replacement system
- Trial name
- TWIST-PILOT-GE (NCT05682066)
- Testing
- Innovalve MR system
- Where
- Georgia
- Volunteers
- 11 people
- Sponsor
- Edwards Lifesciences
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 Insufficiency, Mitral Valve Regurgitation
Real World Expanded Multicenter Study of the MitraClip® System (REALISM)
Prospective, multicenter, continued access registry of the MitraClip® Cardiovascular Valve Repair System in the treatment of mitral valve regurgitation.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation
- Trial name
- REALISM (NCT01931956)
- Testing
- MitraClip® implant
- Where
- 38 sites in United States
- Volunteers
- 965 people
- Sponsor
- Abbott Medical Devices
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 Valve Regurgitation
Tiara™ Transcatheter Mitral Valve Replacement Study
To evaluate the safety and performance of the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Transapical Delivery System.
- Trial name
- TIARA-II (NCT03039855)
- Testing
- TIARA valve and transapical delivery system
- Where
- 20 sites in Germany, Israel and 4 more
- Volunteers
- 157 people
- Sponsor
- Shockwave Medical, Inc.