Safety and Efficacy Study of the Sorin 3D Annuloplasty Ri... | NCT00567853

Studies
Safety and Efficacy Study of the Sorin 3D Annuloplasty Ring For Mitral Repair

NCT00567853

Sponsor

Sorin Group USA, Inc.

Status

Completed

Last Update Posted

Jan 26, 2015Estimated

Enrollment

278Actual

Phase

Phase 3

Conditions

Mitral Valve Regurgitation

Interventions

Implantation of the MEMO 3D Annuloplasty Ring

Countries

United States
Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Jun 2013Actual

Completion Date

Jun 2013Actual

First Submitted Date

Dec 4, 2007

First Submission Date that Met QC Criteria

Dec 4, 2007

First Posted Date

Dec 5, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 22, 2015

Last Update Posted Date

Jan 26, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to collect data on the effectiveness and clinical outcomes of the MEMO 3D Annuloplasty ring as used for mitral valve repair.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

278Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MEMO 3D ring	Other	All patients in the study will be implanted with the MEMO 3D ring	Device: Implantation of the MEMO 3D Annuloplasty Ring

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Implantation of the MEMO 3D Annuloplasty Ring	Device	Implantation of the MEMO 3D Annulopalsty Ring for mitral valve repair.	MEMO 3D ring

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The percentage of patients with successful repair at 6 months.		One Year

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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 evaluations of the study.

Exclusion Criteria:

The subject or subject's legal representative is unwilling to sign the informed consent.
The subject is or will be participating in another medical device or drug clinical trial.
The subject is a minor, prisoner, institutionalized, or is unable to give informed consent.
The subject has a life expectance of less than 1 year.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clark Hargrove, M.D.	University of Pennsylvania Presbyterian Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Minneapolis Heart Institute		Minneapolis	Minnesota	55407	United States
Barnes Jewish Hospital

Condition Browse Module

MeSH Terms

ID	Term
D008944	Mitral Valve Insufficiency

Ancestor Terms

ID	Term
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided