Back to results

CG Future® Annuloplasty Ring/Band Clinical Trial

Primary Purpose

Mitral Valve Insufficiency

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

CG Future Annuloplasty Ring/Band

About this trial

This is an interventional treatment trial for Mitral Valve Insufficiency

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

No control arm

Arm Description

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

Outcomes

Primary Outcome Measures

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

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

The level of mitral valve regurgitation

Secondary Outcome Measures

Full Information

NCT ID

NCT01074671

First Posted

January 26, 2010

Last Updated

October 28, 2015

Sponsor

Medtronic Bakken Research Center

1. Study Identification

Unique Protocol Identification Number

NCT01074671

Brief Title

CG Future® Annuloplasty Ring/Band Clinical Trial

Official Title

Colvin-Galloway Future® Annuloplasty Ring/Band Clinical Trial: Interventional Multi-center Prospective Clinical Outcome Study

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

September 2011 (Actual)

Study Completion Date

September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medtronic Bakken Research Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mitral Valve Insufficiency

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

77 (Actual)

8. Arms, Groups, and Interventions

Arm Title

No control arm

Arm Type

Other

Arm Description

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

Intervention Type

Device

Intervention Name(s)

CG Future Annuloplasty Ring/Band

Other Intervention Name(s)

Colvin Galloway Future Annuloplasty Ring, Colvin Galloway Future Annuloplasty Band, CG Future Annuloplasty Ring, CG Future Annuloplasty Band

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

Within 3 months prior to implantation

Title

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

Time Frame

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

Title

The level of mitral valve regurgitation

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Overall Study Officials: