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Heart FailurePhase 2MVR + CorCapNCT00630266

Confirmation Trial of the Acorn CorCap Cardiac Support Device (CSD) at the Same Time as Mitral Valve Repair

A Phase 2 study testing CorCap CSD in people with Heart Failure, run by Acorn Cardiovascular, Inc. at 12 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Heart Failure
What is being tested?
CorCap CSD
Type of treatment
Medical device
How many people
50 participants
Where
12 sitesin 2 countries
Study dates
Jan 2008to Dec 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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

Who cannot join

  • 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.
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  • 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.
  • Active infection.
  • Pregnancy at the time of enrollment. (Women of child bearing potential must have a negative serum pregnancy test within two weeks prior to enrollment, or be using hormonal contraceptives or intrauterine devices.)
  • Enrolled in another investigational study that would confound interpretation of trial results.
  • Patients who participated as control patients in the previous CorCap PMA randomized trial.
  • Unable to comply with protocol-required follow-up (as judged by primary investigator or referring cardiologist).
  • Late stage heart failure with increased surgical risk as defined by the presence of four or more of the following:
  • LVEDD greater than 80 mm/m2
  • Resting systolic blood pressure (BP) less than or equal to 80 mm Hg (on clinical exam)
  • Atrial fibrillation at time of enrollment or paced rhythm with underlying atrial fibrillation
  • Heart failure greater than or equal to 8 years
  • 6 minute walk less than or equal to 350 meters (1148 feet)
  • POV2 less than or equal to 13 ml/kg/min (CPX test)
  • Exercise induced increase in systolic BP less than 10 percent (CPX test)
  • Previous cardiac surgery
  • BUN greater than 100 mg/dl
  • Cachexia (clinical impression)

Trial locations and contacts

12 sites in 2 countries.

Meegan Anderson, RN, BSN, MBA, CCRA contact

651-260-4822

meegan.anderson@acorncv.com

12 sites in 2 countries

United States11 sites, 11 recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48109-5864

    Cathie Bloem, 734-615-6170, bloem@med.umich.edu

    Steven F Bolling, MD

    Recruiting

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

    Barb Gus, RN, 216-445-6552, gusb@ccf.org

    Randall Starling, MD

    Recruiting

  • Henry Ford Hospital

    Detroit, Michigan, 48202

    Karen Leszczynski, RN, 313-916-3520, kleszcz1@hfhs.org

    Robert Brewer, MD

    Recruiting

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17603

    Linda Bowman, RN, BS, CCRC, 717-290-6681 ext. 203, lbowman@lancasterheart.org

    Jeff Cope, MD

    Recruiting

  • BryanLGH Medical Center

    Lincoln, Nebraska, 68506

    Shari Harre, RN, 402-483-3373, shari@bhi-1.com

    Edward Raines, MD

    Recruiting

  • Nebraska Heart Institute

    Lincoln, Nebraska, 68526

    Deb Baehr, LPN, 402-328-3939, dbaehr@neheart.com

    James Wudel, MD

    Recruiting

  • Newark Beth Israel

    Newark, New Jersey, 07112

    Laura Adams, RN, 973-926-8451, ladams@sbhcs.com

    Mark J Zucker, MD, JD

    Recruiting

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453

    Colleen Gallagher, RN, BSN, 708-346-4044 ext. 27, colleen.gallagher@advocatehealth.com

    Pat Pappas, MD

    Recruiting

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Jessica L Howard, 215-410-6987, jessica.howard@uphs.upenn.edu

    Michael A Acker, MD

    Recruiting

  • PENN-Presbyterian Medical Center

    Philadelphia, Pennsylvania, 19104

    Marsha R. Watts, RN, BSN, 215-662-9595, marsha.watts@uphs.upenn.edu

    Michael A. Acker, MD

    Recruiting

  • Kaiser Permanente Northern California Heart Transplant Program

    Santa Clara, California, 95051

    Patricia Lockyer, RN (CAP), 408-851-3826, patricia.lockyer@kp.org

    Dana Weisshaar, MD

    Recruiting

Other trials in United States

Canada1 site, 1 recruiting

  • Royal Victoria Hospital, McGill University

    Montreal, Quebec, H3A 1A1

    Charlene Barber, RN, 514-934-1934 ext. 36764, charlene.barber@muhc.mcgill.ca

    Renzo Cecere, MD

    Recruiting

Other trials in Canada

About this study

Official title: Clinical Evaluation of Acorn CorCap Cardiac Support Device Concomitant to MVR - A Confirmatory Trial

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.

Read the detailed description

The Acorn CorCap Cardiac Support Device (CSD) is a new therapy for the treatment of heart failure that is designed to reduce left ventricular dilation, which is one of the most important pathophysiological mechanisms underlying the clinical syndrome of heart failure. The Acorn CorCap CSD is intended to reduce wall stress and support the heart, in order to prevent further dilation that is associated with progressive heart failure. It is designed to result in reduced left ventricular size and improve left ventricluar function, which should result in improved patient functional status.

The purpose of the study is to provide confirmatory data to demonstrate an improved benefit-risk profile in support of a Pre-Market Approval (PMA) application for the Acorn CorCap CSD when placed concomitant to Mitral Valve Repair/Replacement (MVR).

The primary efficacy objective is to evaluate patient functional status after 6 months of follow-up. The safety endpoint is perioperative (30 day) mortality.

Conditions
Heart Failure
Being tested
CorCap CSD
Keywords
Heart failure, left ventricular dilation, mitral valve repair, mitral valve replacement
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CorCap CSDDevice

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

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 6 month follow-up

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

    Measured: 6 Month follow-up

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

    Measured: 6 months

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

    Measured: 6 months

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

    Measured: 30 days

Secondary outcomes (2)

  1. Rate of death and SAEs overall and for each specific type of event

    Measured: 6 months

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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2008 (estimated)
  2. Study startJan 2008
  3. Primary completionDec 2009 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00630266
Sponsor's protocol ID
47-1389
Acronym
MVR + CorCap
Status last verified
Jun 2009
First submitted
27 Feb 2008
Last updated
18 Jun 2009
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CorCap CSD in people with Heart Failure, run by Acorn Cardiovascular, Inc. at 12 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Meegan Anderson, RN, BSN, MBA, CCRA (651-260-4822, meegan.anderson@acorncv.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in patient functional status as evaluated using the Minnesota Living with Heart Failure questionnaire (time frame: 6 month follow-up). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00630266.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2009.

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