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1-866-344-0626
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Frequently Asked Questions
Who is the sponsor?
Who is the lead investigator?
Who can I contact for more information on the PEERLESS-HF study?
Who will be doing the core laboratory analyses?
What is the name of the device?
What is the composition of the device?
What are the Inclusion/Exclusion criteria for study participants?
What is the study design?
What types of Adverse Events will be monitored?
What is the duration of the study?
Paracor Medical, Inc.
225 Humboldt Court
Sunnyvale, CA 94089
Phone: (408) 734-6000
Fax: (408) 734-6002
William T. Abraham, MD, FACP, FACC
Professor of Medicine
Chief, Division of Cardiovascular Medicine
The Ohio State University
473 West 12th Avenue, Room 110P DHLRI
Columbus, OH 42310-1252
Dr. Abraham is an internationally recognized researcher in heart failure and has participated as principal investigator in more than 100 multi-center clinical drug and device trials. He has received grants from the National Institutes of Health and the American College of Cardiology.
In addition to authoring more than 350 original papers, abstracts, book chapters, and review articles, he serves on the editorial boards of several major journals including the Journal of Cardiac Failure and Congestive Heart Failure. The findings from a study on cardiac resynchronization (MIRACLE) in chronic heart failure patients, led by Dr. Abraham, were published in The New England Journal of Medicine in June 2002.
In May 2003, Dr.
Abraham co-authored the MIRACLE ICD Trial, a study about combined therapies
and the benefit to heart failure patients that was published by the
Journal of the American Medical Association.
Dr. Abraham is a member of the writing committee to update the American
College of Cardiology/American Heart Association Heart Failure Guidelines.
Who can I contact for more information on the PEERLESS-HF study?
You can call our toll-free, nurse-staffed information line at 1-866-344-0626 to find out more about the clinical research study and the investigational device.
Who will be doing the core laboratory analyses?
Echocardiography:
Martin St. John Sutton, MD
The Center for Quantitative Echocardiography
The Hospital of the University of Pennsylvania
Rhoads Building, Ground Floor
3400 Spruce Street
Philadelphia, PA 19014
Cardiopulmonary Exercise:
Steven J. Keteyian, PhD
Clinical Exercise Physiology Lab
Henry Ford Hospital
6525 Second Avenue
Detroit, MI 48202
What is the name of the device?
HeartNet™ Ventricular Support System
What is the composition of the device?
The HeartNet Ventricular Support System is comprised of an Implant and a Delivery System. The Implant is pre-loaded into the single-use Delivery System, which is used to place the Implant onto the epicardial surface of the heart, surrounding both the left and right ventricles.
HeartNet is made of an elastic silicone-coated Nitinol (nickel titanium) mesh that is designed to mechanically reinforce the walls of the heart to slow or stop the enlargement process, ultimately decreasing the debilitating symptoms of HF.
What are the Inclusion/Exclusion criteria for study participants?
Criteria
for Inclusion
Subjects for this clinical trial must meet ALL of the following criteria:
1. Symptomatic heart failure at enrollment (ACC/AHA Stage C) due to
ischemic or nonischemic dilated cardiomyopathy
2. On stable, evidence-based
medical and device therapy for heart failure
for at least three (3) months prior to randomization (Note: Stable
pharmacological therapy is defined as no more than a 50% reduction
or 200% increase in the medications listed below under 2a; a transition
between ACE inhibitors and ARB’s is allowed within the 3 months
prior to randomization)
a. Pharmacological Therapy (as appropriate)
i. angiotensin converting enzyme (ACE) inhibitors or
angiotensin II receptor blockers (ARB) for patients with ACE
inhibitor intolerance or nitrate/hydralazine at the
investigators discretion
ii. beta blockers
iii. diuretics, aldosterone inhibitors
b. Ejection fraction (EF) less
than or equal to 35% while maintained
on optimal medical therapy
c. Cardiac Resynchronization Therapy (CRT),
Cardiac
Resynchronization Therapy-Defibrillator (CRT-D)
i. If implanted with a CRT or CRT-D, it must be implanted
≥ 3 months before randomization
ii. If currently eligible or anticipated eligibility with a CRT or
CRT-D within 6 months, the patient should not be enrolled
in the study
Specific Qualifying Characteristics
1. Six
(6) minute walk of 150 - 450 m
2. Peak VO2 for males: 10.0 – 20.0
ml/kg/min;
Peak VO2 for females: 9.0 – 18.0 ml/kg/min
3. Left ventricular end
diastolic diameter (LVEDD) < 85 mm and index
< 40 mm/m2 (LVEDD/BSA)
4. Heart failure duration > 6 months
Criteria for Exclusion
Potential subjects will be excluded from the trial if ANY of the following
conditions apply:
Patient History
1. Heart failure due to a reversible condition, such
as acute alcoholic
cardiomyopathy, myxedema, or reversible ischemia
2. Hypertrophic obstructive cardiomyopathy (HOCM)
3. Left ventricular assist device (LVAD), intra-aortic
balloon pump
(IABP) or intravenous inotropes are required or the patient has end
stage heart failure despite maintenance on best medical therapy
4. Myxoma
5. Active infection, sepsis, endocarditis, myocarditis or pericarditis
6.
Myocardial infarction, stroke, transient ischemic attack, cardiac or
other major surgery, or implantable cardioverter defibrillator (ICD)
or
pacemaker implantation in the three months prior to entry
7. Positive pregnancy test for pre-menopausal female
8. Less than 18 years or ≥ 75 years old
9. Hemoglobin level less than 10 gm/dL or creatinine > 2.5 mg/dL
10. Uncontrolled medical conditions that increase surgical risk,
such as
Diabetes Mellitus or COPD
11. Co-morbid condition that in the investigator’s
opinion reduces life
expectancy to less than 2 years
Surgical or Anatomical Considerations
1. Heart measurement too large
or small for Implant sizes
2. Restrictive cardiomyopathy such as due to
amyloidosis, sarcoidosis, or
hemochromatosis
3. Not a candidate for sternotomy or standard thoracotomy
surgical
approaches
4. Expected to have adhesions from previous surgical procedures,
such as
those involving intrapericardial surgery, or medical conditions, such
as
Dressler’s syndrome or hemopericardium
5. History of constrictive pericarditis
6. Previously placed coronary artery bypass grafts (CABG)
or anticipated
need for coronary artery bypass grafting
7. Not a candidate for cardiopulmonary bypass
8. Anatomical mitral valve regurgitation of 2 + or greater at the
time of
enrollment
9. Pulmonary function testing with the following results: FEV1 <1L
or
FEV1 < 50% predicted or FEV1/FVC < 70%
10. Cardiac or thoracic condition
that might require operative correction
(e.g., valvular stenosis, aortic insufficiency). Cardiac transplantation
is not included in this exclusion criterion.
11. Any other elective surgical
procedure at the time of the index
hospitalization or within 30 days, whichever is longer
Other
1. Any other medical condition that, in the judgment of the investigator,
makes the patient a poor candidate for this procedure
2. Currently enrolled
or has participated in the last 30 days in another
therapeutic or interventional clinical study
3. Unwilling or unable to comply with follow-up
4. Unwilling or unable to give signed informed consent
The study design is a randomized (1 treatment subject: 1control subject), prospective, two-arm comparison. The Treatment Group will receive the HeartNet™ Ventricular Support System with optimal medical and device therapy. The Control Group will be treated with optimal medical and device therapy alone and will not receive the HeartNet.
What types of Adverse Events will be monitored?
The incidence of all Adverse Events observed during the study period will be quantified by type and stratified by:
- Procedural (within 30 days of the implant procedure) versus post procedural
- Seriousness (serious or non-serious)
- Relationship to implanted device, the implantation procedure or other etiology
- Anticipated versus unanticipated occurrence
Note: The classification of all adverse events for the purposes of analysis will be based upon the adjudications made by the Clinical Events Committee.
What is the duration of the study?
Up to five years.
