NCT00630266

Brief Summary

The purpose of this study to evaluate patients when they have an Acorn CorCapTM Cardiac Support Device (CSD) placed around their heart for the treatment of heart failure at the same time as their mitral valve surgery. The CorCapTM CSD is intended to support the heart, potentially preventing further dilation that is associated with progressive heart failure, thereby potentially preserving or improving heart function.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2 heart-failure

Geographic Reach
2 countries

12 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

Study Start

First participant enrolled

January 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 6, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Last Updated

June 18, 2009

Status Verified

June 1, 2009

Enrollment Period

1.9 years

First QC Date

February 27, 2008

Last Update Submit

June 16, 2009

Conditions

Heart Failure

Keywords

Heart failureleft ventricular dilationmitral valve repairmitral valve replacement

Outcome Measures

Primary Outcomes (5)

  • Change in patient functional status as evaluated using the Minnesota Living with Heart Failure questionnaire

    6 month follow-up

  • Change in maximal exercise tolerance evaluated using cardiopulmonary exercise (CPX) testing (peak VO2 exercise test)

    6 Month follow-up

  • Change in sub-maximal exercise tolerance as evaluated using the Six Minute Walk test.

    6 months

  • Number of patients who have died (all-cause) or had a re-hospitalization due to heart failure.

    6 months

  • Peri-operative mortality, death occuring within 30 days of baseline surgery.

    30 days

Secondary Outcomes (2)

  • Rate of death and SAEs overall and for each specific type of event

    6 months

  • Change in patient functional status as evaluated using the Minnesota Living with Heart Failure Questionnaire

    12 months

Interventions

CorCap CSDDEVICE

The surgical procedure includes implantation of the CorCap CSD with concommitant mitral valve surgery through a sternotomy.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Dilated cardiomyopathy of either ischemic or non-ischemic origin
  • Patients must be on stable, optimally uptitrated medical therapy recommended according to current guidelines as standard of care of heart failure therapy in the United States. This minimally includes:
  • Angiotensin-converting enzyme inhibitors (ACE) or alternate if ACE not tolerated for greater than or equal to 1 month prior to enrollment (not required for patients with a mitral valve anomaly that is not likely to respond to medication and requires surgical intervention).
  • Treatment with a beta-blocker, unless intolerant, for greater than or equal to 3 months prior to enrollment (not required for patients with a mitral valve anomaly that is not likely to respond to medication and requires surgical intervention).
  • Diuretic at least "prn" (as occasion requires).
  • Cardiac medications unchanged for greater than or equal to 1 month except for diuretic adjustments (not required for patients with a mitral valve anomaly that is not likely to respond to medications and requires surgical intervention).
  • Adult (18 to 80 years).
  • Indexed left ventricular end diastolic dimension (LVEDDi)between 30 mm/m2 and 40 mm/m2 as determined by transthoracic echocardiography.
  • Mitral regurgitation (MR) greater than or equal to 2+ and scheduled for mitral valve repair or replacement. Concomitant tricuspid valve repair or replacement (TVR) and/or atrial fibrillation ablation procedures will be permitted.
  • Left ventricular ejection fraction (LVEF) less than or equal to 45 percent via transthoracic echocardiography, cardiac catheterization, radionuclide scan, or magnetic resonance imaging
  • New York Heart Association Functional Class (NYHA) II, III or IV
  • Geographically available for follow-up
  • Signed Informed Consent

You may not qualify if:

  • Inability to reach maximal effort CPX test as defined by the CPX Core Lab
  • Planned cardiac surgical procedure other than MVR
  • Hypertrophic obstructive cardiomyopathy.
  • Significant cardiomegaly, which is estimated to exceed the largest available size of CorCap CSD.
  • Expectation of existing cardiothoracic adhesions that would cause an inability to gain complete circumferential access to the heart.
  • Existing patent CABG.
  • Candidates for surgical revascularization as determined by an angiogram. Patients with ischemic heart disease who have not had an angiogram within the past 3 years and in whom lesions amenable to revascularization cannot be excluded should have a repeat angiogram.
  • Any condition considered a contraindication for extracorporeal circulation.
  • Use of Intra aortic Balloon Pump (IABP), intravenous inotropic or vasoactive agents within 30 days prior to enrollment. Pre-operative hemodynamic optimization with IABP, IV inotropes or vasoactive agents may be permitted if it is scheduled to occur within 48 hours of planned index surgery.
  • Current or anticipated need for left ventricular assist device (LVAD) or cardiac replacement device.
  • Anticipated need for heart transplant within the next two years.
  • Acute myocardial infarction (AMI), unstable angina, or cerebral vascular accident (CVA) or Transient Ischemic Attack (TIA) within past 3 months.
  • Percutaneous coronary intervention (PCI) or transmyocardial laser revascularization (TMR or PMR) within the past 3 months.
  • Presence of arrhythmias causing hemodynamic instability, history of resuscitated sudden death without subsequent treatment with implantable defibrillator or amiodarone, or atrial fibrillation with a ventricular rate greater than 100 bpm on medication.
  • Co-morbid condition that reduces life expectancy to less than 1 year.
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Kaiser Permanente Northern California Heart Transplant Program

Santa Clara, California, 95051, United States

RECRUITING

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109-5864, United States

RECRUITING

Henry Ford Hospital

Detroit, Michigan, 48202, United States

RECRUITING

BryanLGH Medical Center

Lincoln, Nebraska, 68506, United States

RECRUITING

Nebraska Heart Institute

Lincoln, Nebraska, 68526, United States

RECRUITING

Newark Beth Israel

Newark, New Jersey, 07112, United States

RECRUITING

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

Lancaster General Hospital

Lancaster, Pennsylvania, 17603, United States

RECRUITING

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

PENN-Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Royal Victoria Hospital, McGill University

Montreal, Quebec, H3A 1A1, Canada

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Steven F Bolling, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

  • Michael A Acker, MD

    Hospital of the University of Pennsylvania, Cardiovascular Medicine; Penn-Presbyterian Medical Center

    PRINCIPAL INVESTIGATOR

  • Mario Pompili, MD

    Kaiser Permanente Northern California Heart Transplant Program

    PRINCIPAL INVESTIGATOR

  • James Wudel, MD

    Nebraska Heart Institute

    PRINCIPAL INVESTIGATOR

  • Randall Starling, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

  • Mark J Zucker, MD, JD

    Newark Beth Israel

    PRINCIPAL INVESTIGATOR

  • Renzo Cecere, MD

    Royal Victoria Hospital, McGill University

    PRINCIPAL INVESTIGATOR

  • Pat Pappas, MD

    advocate christ medical center

    PRINCIPAL INVESTIGATOR

  • Robert Brewer, MD

    Henry Ford Hospital

    PRINCIPAL INVESTIGATOR

  • Jeff Cope, MD

    Lancaster General Hospital

    PRINCIPAL INVESTIGATOR

  • Edward Raines, MD

    BryanLGH Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Meegan Anderson, RN, BSN, MBA, CCRA

CONTACT

651-260-4822meegan.anderson@acorncv.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 27, 2008

First Posted

March 6, 2008

Study Start

January 1, 2008

Primary Completion

December 1, 2009

Last Updated

June 18, 2009

Record last verified: 2009-06

Locations

US(11)CA(1)