NCT00567853

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
278

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2007

Longer than P75 for phase_3

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 5, 2007

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

January 26, 2015

Status Verified

January 1, 2015

Enrollment Period

5.8 years

First QC Date

December 4, 2007

Last Update Submit

January 22, 2015

Conditions

Mitral Valve Regurgitation

Keywords

mitral valve regurgitationmitral valve diseasemitral valve repairmitral valve dysfunctionheart valvevalve diseasecardiac surgery

Outcome Measures

Primary Outcomes (1)

  • The percentage of patients with successful repair at 6 months.

    One Year

Secondary Outcomes (1)

  • 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

Study Arms (1)

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

Implantation of the MEMO 3D Annuloplasty RingDEVICE

Implantation of the MEMO 3D Annulopalsty Ring for mitral valve repair.

MEMO 3D ring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Minneapolis Heart Institute

Minneapolis, Minnesota, 55407, United States

Location

Barnes Jewish Hospital

St Louis, Missouri, 63100, United States

Location

University of Pennsylvania Presbyterian Hospital

Philadelphia, Pennsylvania, 19104, United States

Location

The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

Location

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Clark Hargrove, M.D.

    University of Pennsylvania Presbyterian Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2007

First Posted

December 5, 2007

Study Start

August 1, 2007

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

January 26, 2015

Record last verified: 2015-01

Locations

US(4)CA(2)