NCT01074671

Brief Summary

The primary goal of the study is to document the number of patients that are successfully implanted and benefit from the implantation of both a CG Future Annuloplasty ring or a band.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2009

Typical duration for phase_4

Geographic Reach
5 countries

8 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

June 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2010

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 24, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

October 29, 2015

Status Verified

October 1, 2015

Enrollment Period

2.3 years

First QC Date

January 26, 2010

Last Update Submit

October 28, 2015

Conditions

Mitral Valve Insufficiency

Outcome Measures

Primary Outcomes (3)

  • Identification of the patient population for which a CG Future Annuloplasty Ring or Band is chosen to repair the mitral valve insufficiency

    Within 3 months prior to implantation

  • The percentage of patients that are chronically relieved from mitral valve insufficiency

    Within 3 months prior to implantation and at 9 month follow-up

  • The level of mitral valve regurgitation

    Within 3 months prior to implantation and at 9 month follow-up

Study Arms (1)

No control arm

OTHER

There is no control arm as part of the study design.

Device: CG Future Annuloplasty Ring/Band

Interventions

CG Future Annuloplasty Ring/BandDEVICE

A CG Future Annuloplasty Ring or Band will be implanted, following standard care

Also known as: Colvin Galloway Future Annuloplasty Ring, Colvin Galloway Future Annuloplasty Band, CG Future Annuloplasty Ring, CG Future Annuloplasty Band
No control arm

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed and dated the Patient Informed Consent (PIC);
  • Indicated to have a surgical repair for a given degree of moderate to severe mitral valve regurgitation;
  • Willing to return to the implanting hospital for a 9 month follow-up visit

You may not qualify if:

  • Unwilling or inability to sign the PIC;
  • Already participating in another investigational device study, if this would create bias and jeopardize scientific appropriate assessment of the current study endpoints;
  • Life expectancy of less than one year;
  • Pregnant or desire to be pregnant within 12 months of the study treatment;
  • Less than 18 years and more than 85 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Cliniques Universitaires Saint Luc

Brussels, 1200, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

Virga Jesse Hospital

Hasselt, B-3500, Belgium

Location

Technische Universitat Dresden

Dresden, D-01307, Germany

Location

Albertinen Krankenhaus Hamburg

Hamburg, 22457, Germany

Location

Athens Medical Center

Athens, 15155, Greece

Location

Haukeland Universitetssykehus

Bergen, N-5021, Norway

Location

Szpital Wojewódzki Nr 2 w Rzeszowie

Rzeszów, 35-301, Poland

Location

Related Links

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • D C Iliopoulos, Prof

    Athens Medical Center, Greece

    PRINCIPAL INVESTIGATOR

  • M Hendrikx, Dr

    Virga Jesse Hospital, Hasselt, Belgium

    PRINCIPAL INVESTIGATOR

  • K François, Dr

    UZ Gent, Belgium

    PRINCIPAL INVESTIGATOR

  • G El Khoury, Dr

    Cliniques Universitaires Saint Luc, Brussels, Belgium

    PRINCIPAL INVESTIGATOR

  • K Widenka, Dr

    Szpital Wojewódzki Nr 2 w Rzeszowie, Poland

    PRINCIPAL INVESTIGATOR

  • R. Haaverstad, Prof.

    Haukeland Universitetssykehus, Bergen, Norway

    PRINCIPAL INVESTIGATOR

  • K Matschke, Dr.

    Technische Universitat Dresden, Germany

    PRINCIPAL INVESTIGATOR

  • F Riess, Dr.

    Albertinen Krankenhaus Hamburg, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2010

First Posted

February 24, 2010

Study Start

June 1, 2009

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

October 29, 2015

Record last verified: 2015-10

Locations

BE(3)PL(1)DE(2)NO(1)GR(1)