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

Primary Purpose

Heart Failure

Status

Unknown status

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

CorCap CSD

About this trial

This is an interventional supportive care trial for Heart Failure focused on measuring Heart failure, left ventricular dilation, mitral valve repair, mitral valve replacement

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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:
1. 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).
2. 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).
3. Diuretic at least "prn" (as occasion requires).
4. 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

Exclusion Criteria:

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.
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:
1. LVEDD greater than 80 mm/m2
2. Resting systolic blood pressure (BP) less than or equal to 80 mm Hg (on clinical exam)
3. Atrial fibrillation at time of enrollment or paced rhythm with underlying atrial fibrillation
4. Heart failure greater than or equal to 8 years
5. 6 minute walk less than or equal to 350 meters (1148 feet)
6. POV2 less than or equal to 13 ml/kg/min (CPX test)
7. Exercise induced increase in systolic BP less than 10 percent (CPX test)
8. Previous cardiac surgery
9. BUN greater than 100 mg/dl
10. Cachexia (clinical impression)

Sites / Locations

Kaiser Permanente Northern California Heart Transplant ProgramRecruiting
Advocate Christ Medical CenterRecruiting
University of MichiganRecruiting
Henry Ford HospitalRecruiting
BryanLGH Medical CenterRecruiting
Nebraska Heart InstituteRecruiting
Newark Beth IsraelRecruiting
Cleveland Clinic FoundationRecruiting
Lancaster General HospitalRecruiting
Hospital of the University of PennsylvaniaRecruiting
PENN-Presbyterian Medical CenterRecruiting
Royal Victoria Hospital, McGill UniversityRecruiting

Outcomes

Primary Outcome Measures

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

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

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

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

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

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT00630266

First Posted

February 27, 2008

Last Updated

June 16, 2009

Sponsor

Acorn Cardiovascular, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00630266

Brief Title

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

Acronym

MVR + CorCap

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2009

Overall Recruitment Status

Unknown status

Study Start Date

January 2008 (undefined)

Primary Completion Date

December 2009 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Acorn Cardiovascular, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

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

Heart Failure

Keywords

Heart failure, left ventricular dilation, mitral valve repair, mitral valve replacement

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

CorCap CSD

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

6 month follow-up

Title

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

Time Frame

6 Month follow-up

Title

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

Time Frame

6 months

Title

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

Time Frame

6 months

Title

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

Time Frame

30 days

Secondary Outcome Measure Information:

Title

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

Time Frame

6 months

Title

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

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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. 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Meegan Anderson, RN, BSN, MBA, CCRA

Phone

651-260-4822

meegan.anderson@acorncv.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steven F Bolling, MD

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Michael A Acker, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mario Pompili, MD

Organizational Affiliation

Kaiser Permanente Northern California Heart Transplant Program

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

James Wudel, MD

Organizational Affiliation

Nebraska Heart Institute

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Randall Starling, MD

Organizational Affiliation

The Cleveland Clinic

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mark J Zucker, MD, JD

Organizational Affiliation

Newark Beth Israel

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Renzo Cecere, MD

Organizational Affiliation

Royal Victoria Hospital, McGill University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Pat Pappas, MD

Organizational Affiliation

advocate christ medical center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Robert Brewer, MD

Organizational Affiliation

Henry Ford Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jeff Cope, MD

Organizational Affiliation

Lancaster General Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Edward Raines, MD

Organizational Affiliation

BryanLGH Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kaiser Permanente Northern California Heart Transplant Program

City

Santa Clara

State/Province

California

ZIP/Postal Code

95051

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Patricia Lockyer, RN (CAP)

Phone

408-851-3826

patricia.lockyer@kp.org

First Name & Middle Initial & Last Name & Degree

Dana Weisshaar, MD

First Name & Middle Initial & Last Name & Degree

Mario Pompili, MD

First Name & Middle Initial & Last Name & Degree

Vic Melikian, MD

First Name & Middle Initial & Last Name & Degree

Jay LaBourene, MD

First Name & Middle Initial & Last Name & Degree

Maria Ansari, MD

Facility Name

Advocate Christ Medical Center

City

Oak Lawn

State/Province

Illinois

ZIP/Postal Code

60453

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Colleen Gallagher, RN, BSN

Phone

708-346-4044

Ext

colleen.gallagher@advocatehealth.com

First Name & Middle Initial & Last Name & Degree

Pat Pappas, MD

First Name & Middle Initial & Last Name & Degree

Antone Tatooles, MD

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109-5864

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cathie Bloem

Phone

734-615-6170

bloem@med.umich.edu

First Name & Middle Initial & Last Name & Degree

Steven F Bolling, MD

Facility Name

Henry Ford Hospital

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Karen Leszczynski, RN

Phone

313-916-3520

kleszcz1@hfhs.org

First Name & Middle Initial & Last Name & Degree

Robert Brewer, MD

First Name & Middle Initial & Last Name & Degree

Hassan W. Nemeh, MD

First Name & Middle Initial & Last Name & Degree

Barbara Czerska, MD

Facility Name

BryanLGH Medical Center

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68506

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shari Harre, RN

Phone

402-483-3373

shari@bhi-1.com

First Name & Middle Initial & Last Name & Degree

Edward Raines, MD

First Name & Middle Initial & Last Name & Degree

Steven Krueger, MD

Facility Name

Nebraska Heart Institute

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68526

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Deb Baehr, LPN

Phone

402-328-3939

dbaehr@neheart.com

First Name & Middle Initial & Last Name & Degree

James Wudel, MD

First Name & Middle Initial & Last Name & Degree

Deepak Gangahar, MD

First Name & Middle Initial & Last Name & Degree

Kaliprasad N Ayala, MD

Facility Name

Newark Beth Israel

City

Newark

State/Province

New Jersey

ZIP/Postal Code

07112

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Laura Adams, RN

Phone

973-926-8451

ladams@sbhcs.com

First Name & Middle Initial & Last Name & Degree

Mark J Zucker, MD, JD

First Name & Middle Initial & Last Name & Degree

Margarita Camacho, MD

First Name & Middle Initial & Last Name & Degree

Ravi Karanam, MD

First Name & Middle Initial & Last Name & Degree

David A Baran, MD

Facility Name

Cleveland Clinic Foundation

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Barb Gus, RN

Phone

216-445-6552

gusb@ccf.org

First Name & Middle Initial & Last Name & Degree

Randall Starling, MD

First Name & Middle Initial & Last Name & Degree

Nicholas Smedira, MD

Facility Name

Lancaster General Hospital

City

Lancaster

State/Province

Pennsylvania

ZIP/Postal Code

17603

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Linda Bowman, RN, BS, CCRC

Phone

717-290-6681

Ext

203

lbowman@lancasterheart.org

First Name & Middle Initial & Last Name & Degree

Jeff Cope, MD

First Name & Middle Initial & Last Name & Degree

Roy Small, MD

Facility Name

Hospital of the University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jessica L Howard

Phone

215-410-6987

jessica.howard@uphs.upenn.edu

First Name & Middle Initial & Last Name & Degree

Michael A Acker, MD

First Name & Middle Initial & Last Name & Degree

Mariell Jessup, MD

First Name & Middle Initial & Last Name & Degree

Y. Joseph Woo, MD

Facility Name

PENN-Presbyterian Medical Center

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marsha R. Watts, RN, BSN

Phone

215-662-9595

marsha.watts@uphs.upenn.edu

First Name & Middle Initial & Last Name & Degree

Michael A. Acker, MD

First Name & Middle Initial & Last Name & Degree

Y. Joseph Woo, MD

First Name & Middle Initial & Last Name & Degree

W. Clark Hargrove, MD

First Name & Middle Initial & Last Name & Degree

Rohinton Morris, MD

First Name & Middle Initial & Last Name & Degree

Wilson Szeto, MD

First Name & Middle Initial & Last Name & Degree

Ross Zimmer, MD

Facility Name

Royal Victoria Hospital, McGill University

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3A 1A1

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Charlene Barber, RN

Phone

514-934-1934

Ext

36764

charlene.barber@muhc.mcgill.ca

First Name & Middle Initial & Last Name & Degree

Renzo Cecere, MD

First Name & Middle Initial & Last Name & Degree

Nadia Giannetti, MD

12. IPD Sharing Statement

Learn more about this trial

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

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