Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:2/6/2019
Start Date:April 2010
End Date:April 2015

Use our guide to learn which trials are right for you!

Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy Study

The purpose of this clinical study is to evaluate the safety and clinical effectiveness of
use of a physician-directed, patient self-management system, guided by left atrial pressure
measurements, for use in patients with heart failure. The system allows patients to adjust
their HF medications daily based on a physician-directed prescription plan and their current
HF status, similar to the manner in which diabetes patients manage their insulin therapy. The
goal of the LAPTOP-HF study is to demonstrate reductions in episodes of worsening heart
failure (HF) and hospitalizations in patients who are managed with the left atrial pressure
(LAP) management system (treatment group) versus those who receive only the current standard
of care (control group).

The Sponsor believes that direct measurements from your heart may provide an accurate,
reliable and medically acceptable way of better managing your heart failure prior to your
noticing symptoms or being hospitalized. This may enable you and your doctor to take
preventative measures, by fine tuning your care including more frequently adjusting your
medications with a goal of avoiding hospitalization.

Inclusion Criteria:

- Have ischemic or non-ischemic cardiomyopathy with either a history of reduced or
preserved ejection fraction and heart failure for at least 6 months.

- NYHA Class III documented at screening visit.

- Be receiving appropriate medical therapy for heart failure as per ACC/AHA guidelines
(such as diuretic, angiotensin-converting enzyme (ACE) inhibitor or angiotensin
receptor blocker (ARB) and beta-blocker) for at least 3 months prior to the
randomization visit. Subject has been on stable medications maximized to the subject's
tolerance of ACE or ARB and beta-blockers as determined by the study investigator for
at least 30 days prior to randomization. Stable is defined as no more than a 100%
increase or 50% decrease in dose. These criteria may be waved if a subject is
intolerant of ACE, ARB or beta-blockers, or these agents are not indicated under the
Guidelines. Such intolerance or lack of indications must be documented.

- Have a minimum of one (1) prior hospital admission within the last 12 months for acute
exacerbation of HF of at least one (1) calendar date change duration requiring
intravenous or invasive HF therapy. If CRT device previously implanted, the heart
failure hospitalization must be ≥ 30 days after CRT implantation. Alternatively, if
patients have not had a heart failure hospitalization within the prior 12 months, they
must have an elevated Brain Natriuretic Peptide (BNP) level of at least 400pg/ml or an
N-terminal pro-BNP (NT-proBNP) level of at least 1,500pg/ml, according to local
measurement at the time of screening (within 30 days of the screening visit/consent)

- Provide informed consent for study participation and be willing and able to comply
with the required tests, treatment instructions and follow-up visits.

- Are able to schedule Therapy Initiation within two weeks. Enrollment/Randomization may
be delayed until this criterion is met.

Exclusion Criteria:

- Are under the age of 18 years.

- Are pregnant.

- Have intractable HF with resting symptoms despite maximal medical therapy (persistent
NYHA Class IV and ACC/AHA HF Stage D). This includes patients receiving continuous or
intermittent outpatient intravenous vasoactive medications (e.g., IV inotropes, IV
vasodilators), patients treated with a ventricular assist device (VAD), and patients
who have received a cardiac transplant or are listed for cardiac transplantation and
likely to be transplanted within 12 months - even if their functional status has
improved to NYHA Class III. Patients listed for cardiac transplantation who are not
likely to be transplanted within 12 months and who have improved to NYHA Class III
without outpatient IV vasoactive medications or a VAD are eligible for the study, if
they meet the other inclusion/exclusion criteria.

- Have a resting systolic blood pressure < 80 or > 180 mmHg.

- Have an acute MI, Acute Coronary Syndrome, Percutaneous Coronary Intervention (PCI),
new cardiac rhythm management device (Pacemaker, ICD, and CRT), CRM system revision,
lead extraction or cardiac or other major surgery within 40 days.

- Have known coexisting, untreated, hemodynamically severe stenotic valve lesions,
vegetations, hypertrophic cardiomyopathy with significant resting or provoked
subaortic gradient, acute myocarditis, tamponade, or large pericardial effusion.

- Have an Atrial Septal Defect or Patent Foramen Ovale (with more than trace shunting on
color Doppler or intravenous bubble study) or surgical correction of significant
congenital heart disease involving atrial septum such as PFO or ASD closure device.

- Have a Stroke or Transient Ischemic Attack within 6 months.

- Have inadequate vascular access for device implantation.

- Have baseline 2-D echocardiographic evidence of, or history of, unresolved left atrial
or ventricular thrombus.

- Have a recent (within 6 months) or persistent deep venous thrombosis, pulmonary or
systemic thromboembolism.

- Have a life expectancy < 1 year due to another illness.

- Have coagulopathy or uninterruptible anticoagulation therapy or contraindication for
all of the forms of antiplatelet/anticoagulant treatments anticipated in the protocol.

- Have an Estimated Glomerular Filtration Rate that remains < 30 ml/min/1.73 M2 by the
MDRD method.

- Have a Liver Function Test > 3 times upper limit of normal.

- Have Severe Pulmonary Disease producing frequent hospitalizations for respiratory
distress and requiring continuous home oxygen.

- Have pulmonary hypertension with a pulmonary artery systolic pressure of greater than
or equal to 80 mm/Hg on screening echocardiogram.

- Have an active infection requiring systemic antibiotics.

- Have a history of active drug addiction, active alcohol abuse, or psychiatric hospital
admission for psychosis within the prior 2 years.

- Are currently participating in a clinical investigation that includes an active
treatment arm.

- Are unable to demonstrate understanding and capability of using the PAM patient
advisory module appropriately.

- Patient does not have access to a telephone line usable for remote PAM follow-up or
electrical outlet for recharging PAM.
We found this trial at
64
sites
Charlotte, North Carolina 28203
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
?
mi
from
Boston, MA
Click here to add this to my saved trials
75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
?
mi
from
Boston, MA
Click here to add this to my saved trials
8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
University of Rochester The University of Rochester is one of the country's top-tier research universities....
?
mi
from
Rochester, NY
Click here to add this to my saved trials
1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Akron, Ohio 44304
?
mi
from
Akron, OH
Click here to add this to my saved trials
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Atlanta, Georgia 30324
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Austin, Texas 78756
?
mi
from
Austin, TX
Click here to add this to my saved trials
?
mi
from
Austin, TX
Click here to add this to my saved trials
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlottesville, Virginia 22908
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Christchurch, 8011
?
mi
from
Christchurch,
Click here to add this to my saved trials
Cincinnati, Ohio 45227
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Cleveland, Ohio 44106
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Des Moines, Iowa 50314
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
?
mi
from
Durham, NC
Click here to add this to my saved trials
Fullerton, California 92835
?
mi
from
Fullerton, CA
Click here to add this to my saved trials
?
mi
from
Glendale, CA
Click here to add this to my saved trials
500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
?
mi
from
Hershey, PA
Click here to add this to my saved trials
Houston, Texas 77225
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Jacksonville, Florida 32209
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Kansas City, Kansas 66160
?
mi
from
Kansas City, KS
Click here to add this to my saved trials
Kansas City, Missouri 64111
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
La Jolla, California 92037
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
Lancaster, Pennsylvania 17603
?
mi
from
Lancaster, PA
Click here to add this to my saved trials
Lexington, Kentucky
859) 257-9000
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
?
mi
from
Lexington, KY
Click here to add this to my saved trials
Lincoln, Nebraska 68506
?
mi
from
Lincoln, NE
Click here to add this to my saved trials
Los Angeles, California 90033
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Louisville, Kentucky 40202
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Memphis, Tennessee 38120
?
mi
from
Memphis, TN
Click here to add this to my saved trials
Midland, Michigan 48640
?
mi
from
Midland, MI
Click here to add this to my saved trials
Milwaukee, Wisconsin 53201
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
Minneapolis, Minnesota 55407
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
100 Madison Ave
Morristown, New Jersey 7960
(973) 971-5000
Morristown Memorial Hospital Atlantic Health System – comprised of Morristown Medical Center, Overlook Medical Center,...
?
mi
from
Morristown, NJ
Click here to add this to my saved trials
?
mi
from
Murray, UT
Click here to add this to my saved trials
Nashville, Tennessee 37212
?
mi
from
Nashville, TN
Click here to add this to my saved trials
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
1514 Jefferson Hwy.
New Orleans, Louisiana 70121
504-842-3000
Ochsner Medical Center Ochsner Medical Center is located near uptown New Orleans and includes acute...
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
?
mi
from
Newark, NJ
Click here to add this to my saved trials
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
Oakbrook Terrace, Illinois 60181
?
mi
from
Oakbrook Terrace, IL
Click here to add this to my saved trials
Ogden, Utah 84403
?
mi
from
Ogden, UT
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73120
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Palo Alto, California 95054
?
mi
from
Palo Alto, CA
Click here to add this to my saved trials
Phoenix, Arizona 85032
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15212
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15240
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Portland, Oregon 97220
?
mi
from
Portland, OR
Click here to add this to my saved trials
Royal Oak, Michigan 48314
?
mi
from
Royal Oak, MI
Click here to add this to my saved trials
Sacramento, California 95815
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
San Francisco, California 94143
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
Santa Monica, California 90404
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
Santa Rosa, California 95405
?
mi
from
Santa Rosa, CA
Click here to add this to my saved trials
Worcester, Massachusetts 01655
?
mi
from
Worcester, MA
Click here to add this to my saved trials
?
mi
from
Wynnewood, PA
Click here to add this to my saved trials