NCT00512005

Brief Summary

The purpose of this prospective, non-randomized, single-arm feasibility study is to evaluate safety and feasibility of the iCoapsys System in patients with functional mitral valve insufficiency caused by annular dilation and/or papillary muscle displacement.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2008

Longer than P75 for phase_1

Geographic Reach
1 country

4 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

August 6, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2007

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

June 24, 2009

Status Verified

May 1, 2008

Enrollment Period

1.9 years

First QC Date

August 6, 2007

Last Update Submit

June 23, 2009

Conditions

Mitral Valve RegurgitationLeft Ventricular DysfunctionHeart FailureMitral InsufficiencyMitral IncompetenceIschemic Heart Disease

Keywords

Functional Mitral Regurgitation (FMR)Ischemic Mitral RegurgitationLess invasive repairPercutaneous MV repairMitral Valve RepairHeart FailureLeft Ventricular Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Intra-procedural implant safety of iCoapsys System, Peri-procedural safety of the iCoapsys System, Intra-procedural MR reduction with the iCoapsys System

    Intra-procedure and peri-procedure

Secondary Outcomes (1)

  • Minnesota Living with Heart Failure Questionnaire, 6-Minute Hallwalk, LV Chamber Volumes

    1, 3, 6, 12, 18, 24 months and annually thereafter

Interventions

Percutaneous mitral valve repairDEVICE

Ventricular reshaping to treat functional mitral insufficiency

Also known as: iCoapsys System

Eligibility Criteria

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

You may qualify if:

  • Grade 3 or 4 functional mitral valve regurgitation per 2D echocardiography.
  • NYHA Class II and LVEF greater than or equal to 25% or NYHA Class III and LVEF greater than or equal to 30%

You may not qualify if:

  • History of pericarditis.
  • Creatinine \> 2.2 at the time of the procedure
  • INR \> 1.8 at the time of the procedure
  • Prior pericardial intervention (including CABG, pericardiotomy or pericardiocentesis).
  • Any endovascular therapeutic interventional or surgical procedure performed within 30 days prior to the index procedure (e.g., stent placement).
  • Any planned therapeutic interventional or surgical procedure planned within 30 days following the index procedure
  • Open chest surgery contraindication (e.g., acute respiratory distress, endocarditis, myocarditis).
  • Structural abnormality of the mitral valve
  • Valve disease resulting in insufficiency or stenosis of the aortic, pulmonary or tricuspid valve requiring intervention.
  • Pericardial effusion \>5 mm via echocardiography.
  • Posterior wall end-diastolic dimension \>1.3 cm.
  • Left ventricular end diastolic diameter \> 7.0 cm.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Emory University Hospital

Atlanta, Georgia, 30322, United States

RECRUITING

Evanston Northwestern Healthcare - Evanston Hospital

Evanston, Illinois, 60201, United States

RECRUITING

Shawnee Mission Hospital

Shawnee Mission, Kansas, 66204, United States

RECRUITING

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55440, United States

RECRUITING

MeSH Terms

Conditions

Mitral Valve InsufficiencyVentricular Dysfunction, LeftHeart FailureMyocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular DysfunctionVascular Diseases

Central Study Contacts

Cyril J. Schweich, MD

CONTACT

763 494 5400schweich@myocor.com

Adam K Hoyhtya, MS

CONTACT

763 494 5430hoyhtya@myocor.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 6, 2007

First Posted

August 7, 2007

Study Start

January 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2013

Last Updated

June 24, 2009

Record last verified: 2008-05

Locations

US(4)