NCT00428103

Brief Summary

The primary aim of this study is to assess the changes on the shape and function of the left ventricle in patients with severe mitral valve regurgitation due to congestive heart failure and cardiomyopathy who undergo mitral valve reconstruction with a Geoform ring. Three-dimensional echocardiogram will be used for precise evaluation of the shape and function of the ventricle.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

October 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2007

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

February 28, 2013

Status Verified

February 1, 2013

Enrollment Period

6.2 years

First QC Date

January 25, 2007

Last Update Submit

February 26, 2013

Conditions

Mitral Valve RegurgitationCongestive Heart FailureCardiomyopathy

Keywords

Mitral valve regurgitation

Outcome Measures

Primary Outcomes (2)

  • To assess changes on left ventricular geometry and function using 3D echocardiography in patients with cardiomyopathy and severe mitral regurgitation who undergo mitral valve annuloplasty with a Geoform ring.

    Post operative Mitral Valve repair

  • To evaluate effects on mitral valve annuloplasty with a Geoform ring on functional status.

    Postoperative Mitral Valve repair

Secondary Outcomes (3)

  • To evaluate effect of mitral valve annuloplasty with a Geoform ring on mortality.

    Postoperative

  • To evaluate effects on hospitalization for congestive heart failure.

    Hospital admissions that occur after intial postoperative discharge

  • To evaluate effect on the need of further interventions for congestive heart failure (insertion of ventricular assist device, transplantation, cardiac resynchronization therapy).

    Postoperative Mitral Valve repair

Interventions

3 dimensional echocardiographyPROCEDURE

Lab tests: BNP, 6 minute walk test Transthoracic 3D echocardiogram

Eligibility Criteria

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

You may qualify if:

  • Patients would be at least 18 years old.
  • They will have history of congestive heart failure and be in New York Heart Association Class III or IV.
  • Their left ventricular ejection fraction will be less or equal to 30%.
  • They will have moderate or severe mitral regurgitation as determined by echocardiogram. Echocardiogram's criteria for severe mitral regurgitation will be:
  • regurgitant volume greater than 50 ml,
  • regurgitant fraction greater than 50% and
  • effective regurgitant orifice greater than 40 mm2.
  • If the quantitative criteria are not available, severity of the MR will be graded qualitative in grades I, II, III, and IV. Patients with mitral regurgitation in grade III and IV will be eligible to be included in the study.

You may not qualify if:

  • Cancer - Metastatic or any cancer within five years except patients with non- melanoma skin cancer.
  • Recent stroke (less than six months).
  • Severe COPD (patients with an FEV1 less than .8 liters).
  • Patients on inotropic infusion preoperatively.
  • Patients in atrial fibrillation.
  • Pregnant patients.
  • Patients with any other valvular disease that required surgical intervention except tricuspid valve disease.
  • Patients that will require surgical ventricular restoration.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (11)

  • Smolens IA, Bolling SF. Surgical approaches to dilated cardiomyopathy. Curr Cardiol Rep. 2000 Mar;2(2):99-105. doi: 10.1007/s11886-000-0005-6.

    PMID: 10980879BACKGROUND

  • Romano MA, Bolling SF. Update on mitral repair in dilated cardiomyopathy. J Card Surg. 2004 Sep-Oct;19(5):396-400. doi: 10.1111/j.0886-0440.2004.04079.x.

    PMID: 15383049BACKGROUND

  • Levi GS, Bolling SF, Bach DS. Eccentric mitral regurgitation jets among patients having sustained inferior wall myocardial infarction. Echocardiography. 2001 Feb;18(2):97-103. doi: 10.1046/j.1540-8175.2001.00097.x.

    PMID: 11262532BACKGROUND

  • Romano MA, Bolling SF. Mitral valve repair as an alternative treatment for heart failure patients. Heart Fail Monit. 2003;4(1):7-12.

    PMID: 12808479BACKGROUND

  • Badhwar V, Bolling SF. Mitral valve surgery in the patient with left ventricular dysfunction. Semin Thorac Cardiovasc Surg. 2002 Apr;14(2):133-6. doi: 10.1053/stcs.2002.32314.

    PMID: 11988951BACKGROUND

  • Bolling SF. Mitral reconstruction in cardiomyopathy. J Heart Valve Dis. 2002 Jan;11 Suppl 1:S26-31.

    PMID: 11843517BACKGROUND

  • Bolling SF, Smolens IA, Pagani FD. Surgical alternatives for heart failure. J Heart Lung Transplant. 2001 Jul;20(7):729-33. doi: 10.1016/s1053-2498(01)00239-x.

    PMID: 11448798BACKGROUND

  • Smolens IA, Pagani FD, Bolling SF. Mitral valve repair in heart failure. Eur J Heart Fail. 2000 Dec;2(4):365-71. doi: 10.1016/s1388-9842(00)00125-2.

    PMID: 11113712BACKGROUND

  • Bolling SF. Mitral valve reconstruction in the patient with heart failure. Heart Fail Rev. 2001 Sep;6(3):177-85. doi: 10.1023/a:1011421014480.

    PMID: 11391035BACKGROUND

  • Otsuji Y, Handschumacher MD, Schwammenthal E, Jiang L, Song JK, Guerrero JL, Vlahakes GJ, Levine RA. Insights from three-dimensional echocardiography into the mechanism of functional mitral regurgitation: direct in vivo demonstration of altered leaflet tethering geometry. Circulation. 1997 Sep 16;96(6):1999-2008. doi: 10.1161/01.cir.96.6.1999.

    PMID: 9323092BACKGROUND

  • Verhey JF, Nathan NS, Rienhoff O, Kikinis R, Rakebrandt F, D'Ambra MN. Finite-element-method (FEM) model generation of time-resolved 3D echocardiographic geometry data for mitral-valve volumetry. Biomed Eng Online. 2006 Mar 3;5:17. doi: 10.1186/1475-925X-5-17.

    PMID: 16512925BACKGROUND

MeSH Terms

Conditions

Mitral Valve InsufficiencyHeart FailureCardiomyopathies

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Juan Crestanello, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR

  • Nadia Nathan, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR

  • Subha Raman, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR

  • Steven Bolling, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

  • Min Pu, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Surgery

Study Record Dates

First Submitted

January 25, 2007

First Posted

January 29, 2007

Study Start

October 1, 2006

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

February 28, 2013

Record last verified: 2013-02

Locations

US(1)