Clinical trials: Degenerative Heart Valve Disease
Complex Congenital Heart Defect, Dysfunctional RVOT Conduit
COMPASSION S3 Post-Approval Study
This study will monitor device performance and outcomes of the SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted surgical valve…
- Conditions
- Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration
- Trial name
- NCT04860765
- Testing
- SAPIEN 3 THV
- Where
- 19 sites in United States
- Volunteers
- 150 people
- Sponsor
- Edwards Lifesciences
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
Early Feasibility Study of the Neovasc Tiara™ Mitral Valve System
The purpose of this study is to evaluate the safety and initial performance of the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Transapical Delivery System.
- Trial name
- TIARA-I (NCT02276547)
- Testing
- Mitral valve replacement
- Where
- 10 sites in United States, Belgium and 1 more
- Volunteers
- 27 people
- Sponsor
- Shockwave Medical, Inc.
Degenerative Mitral Valve Disease, Mitral Valve Regurgitation
Chordal Repair for Transcatheter Mitral Valve Repair (TMVr)
A multi-center evaluation of the Pipeline chordal repair system for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve repair.
- Trial name
- NCT04281940
- Testing
- Transcatheter implantation of chordal repair system
- Where
- 4 sites in Georgia, Paraguay and 1 more
- Volunteers
- 7 people
- Sponsor
- Pipeline Medical
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 Regurgitation, Mitral Valve Disease
Caisson Transcatheter Mitral Valve Replacement (TMVR)
The purpose of this study is to assess the safety and performance of Transcatheter Mitral Valve Replacement (TMVR) system for the treatment of severe, symptomatic mitral regurgitation (MR).
- Conditions
- Mitral Regurgitation, Mitral Valve Disease, Mitral Valve Failure, Mitral Disease
- Trial name
- INTERLUDE (NCT03661398)
- Testing
- Transcatheter Mitral Valve Replacement
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Caisson Interventional LLC
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
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 Valve Regurgitation
Safety and Performance Study of the NeoChord Device
The purpose of this study is to demonstrate the safety and performance of the NeoChord DS1000 Artificial Chordae Delivery System in implanting ePTFE sutures(s) as artificial neochordae in patients with mitral regurgitation.
- Trial name
- TACT (NCT01777815)
- Testing
- NeoChord DS1000 Artificial Chordae Delivery System
- Where
- 8 sites in Denmark, Germany and 2 more
- Volunteers
- 30 people
- Sponsor
- NeoChord
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
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
A Feasibility Registry of Actigraphy Monitoring in Degenerative Mitral Regurgitation Subjects Receiving the MitraClip® Device
A prospective, open-label, and multi-centered feasibility registry.
- Trial name
- VELOCITY (NCT02858245)
- Testing
- No intervention - registry
- Where
- 8 sites in United States
- Volunteers
- 30 people
- Sponsor
- Abbott Medical Devices
Mitral Valve Regurgitation
CardiAQ-Edwards™ Transcatheter Mitral Valve Replacement (TMVR) Study
Clinical study to evaluate the safety and performance of the CardiAQ-Edwards™ Transcatheter Mitral Valve
- Trial name
- RELIEF (NCT02722551)
- Testing
- Transcatheter Mitral Valve Re-placement (TMVR) with the CardiAQ-Edwards™ Transcatheter Mitral Valve
- Where
- 15 sites in Canada, Denmark and 5 more
- 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 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
Symptomatic Degenerative Aortic Stenosis, Severe Aortic Stenosis
CONFIDENCE Registry to Assess Safety and Performance of Portico System to Treat Patients With Severe Aortic Stenosis.
The purpose of this clinical investigation is to characterize the procedural safety and device performance of transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in patients with symptomatic degenerative…
- Trial name
- NCT03752866
- Testing
- Portico™ Valve, Portico Delivery System(s) and Loading System(s), Portico™ Valve, FlexNav Delivery System(s) and Loading System(s)
- Where
- 28 sites in Australia, Belgium and 7 more
- Volunteers
- 1,001 people
- Sponsor
- Abbott Medical Devices
Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration
COMMENCE Pulmonary: Clinical Evaluation of Edwards Pericardial Aortic Bioprosthesis (Model 11000A) for Pulmonary Valve Replacement
The objective of this trial is to assess the safety and effectiveness of the Edwards Pericardial Aortic Bioprosthesis Model 11000A, in the pulmonary position in pediatric and adult subjects five years or older requiring…
- Conditions
- Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration, Congenital Pulmonary Valve Abnormality
- Trial name
- COMMENCE-P (NCT02656290)
- Testing
- Edwards Pericardial Aortic Bioprosthesis Model 11000A
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Edwards Lifesciences
Mitral Regurgitation, Degenerative Mitral Valve Disease
Safety and Efficacy of the GeminiOne Transcatheter Valve Edge-to-Edge Repair System in Patients With Moderate-severe or Severe Degenerative Mitral Regurgitation
To observe and evaluate the safety and efficacy of the GeminiOne Transcatheter Valve Edge-to-Edge Repair System in Patients With Moderate-severe or Severe Degenerative Mitral Regurgitation through a prospective, multicenter…
- Trial name
- NCT05655897
- Testing
- GeminiOne Transcatheter Valve Edge-to-Edge Repair System
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Peijia Medical Technology (Suzhou) Co., Ltd.
Transcatheter Mitral Valve Repair of Degenerative Mitral Regurgitation
A Clinical Study of X-Clip Mitral Valve Clip System and Steerable Guide System for Transcatheter Mitral Valve Repair of Degenerative Mitral Regurgitation
Shenzhen Lifevalve Medical Scientific Co., Ltd. has developed a new X-Clip Mitral Valve Clip System and its compatible Steerable Guide System, aiming to provide transcatheter mitral valve repair for patients with degenerative…
- Trial name
- NCT07660185
- Testing
- X-Clip Treatment for Degenerative Mitral Regurgitation
- Where
- 3 sites in Spain
- Volunteers
- 15 people
- Sponsor
- Shenzhen Lifevalve Medical Scientific Co., Ltd.
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