Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy
Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy
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.