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Implantation of the MEMO 3D Annuloplasty Ring

Phase 3

Mitral Valve Regurgitation | Unknown | Cardiovascular |BrainsWay Ltd.|Last Updated: Jan 26, 2015

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment278

FDA Designations

No designations recorded

Clinical trial landscape

Implantation of the MEMO 3D Annuloplasty Ring · 1 trial · 1 indication

Phase 3 1
NCT00567853Safety and Efficacy Study of the Sorin 3D Annuloplasty Ring For Mitral RepairMitral Valve Regurgitation
COMPLETED278 Analytics
PHASE3COMPLETED
Safety and Efficacy Study of the Sorin 3D Annuloplasty Ring For Mitral Repair
Mitral Valve Regurgitation
NCT00567853278
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Study Endpoints

Primary Endpoints

The percentage of patients with successful repair at 6 months.
One Year

Secondary Endpoints

Freedom from re-operation at 12 months. Preoperative and postoperative mitral valve regurgitation and LV dimensions and mass assessed by echocardiography. Actuarial survival and freedom from clinical events at 12 months.
12 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MEMO 3D ringOTHERAll patients in the study will be implanted with the MEMO 3D ring

Interventions

NameTypeDescription
Implantation of the MEMO 3D Annuloplasty RingDEVICEImplantation of the MEMO 3D Annulopalsty Ring for mitral valve repair.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * The subject is 18 years old or older * An annuloplasty ring is indicated for reinforcement of a dysfunctional or diseased native mitral valve according to the current medical practice for valvular repair at each site. * The subject is able to return for all follow-up evaluatio...

Countries:United StatesCanada
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