Testing CardioMems for chronic heart failure

Exclusion

• −History of pulmonary embolism or recurrent deep vein thrombosis;
• −Persistent NYHA Class IV and ACC/AHA HF Stage D, patients implanted with a ventricular assist device (VAD), or patients listed for cardiac transplantation and likely to be transplanted within 12 months;
• −Coexisting severe stenotic valve lesions, endocarditis, obstructive hypertrophic cardiomyopathy, acute myocarditis, tamponade, or large pericardial effusion;
• −Clinically too unstable to be followed remotely; this includes but is not limited to:
• −Resting systolic blood pressure \< 80 or \> 180 mmHg;
• −Resting heart rate \> 100 bpm;
• −Stage IV or V chronic kidney disease (Estimated Glomerular Filtration Rate (eGFR) that remains \< 30 mL/min/1.73m2 by MDRD) or nonresponsive to diuretic therapy or on chronic renal dialysis;
• −Severe pulmonary hypertension with systolic pulmonary artery pressure ≥80 mmHg;
• −Pulmonary hypertension other than group II PH;
• −Anemia requiring transfusions, iron infusions, or hemoglobin below 100;
• −Coagulopathy or uninterruptible anticoagulation therapy or contraindication to antiplatelet/anticoagulant treatments anticipated in the protocolProtocolThe detailed plan a study must follow.Read more →;
• −Intolerance to aspirin or clopidogrel;
• −Active infection requiring systemic antibiotics;
• −Unwillingness to sign informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → or to attend the outpatient clinic;
• −Participation in another research trial with intervention;
• −Discharge to a chronic care facility or residence in an outlying area;
• −Any condition that in the opinion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → would jeopardize the evaluation for efficacy or safety or be associated with poor adherence to the protocol, including cognitive decline.
• −Life expectancy \<1 year;
• −Pregnant or lactating women or women of childbearing potential who are not protected from pregnancy by an accepted method of contraception, such as the oral contraceptive pill, an intrauterine device or surgical sterilization. If necessary a negative urine or blood test will be performed before randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →
• −Recent cardiovascular event: Acute coronary syndrome (STEMI/NSTEMI; a small rise in the troponin level would be expected in this population and is not a contraindication for enrolmentEnrolmentThe number of participants a study plans to include, or has included.Read more →); Percutaneous Coronary Intervention (PCI), new cardiac rhythm management (CRM) device (pacemaker, ICD and CRT), CRM system revision, lead extraction or cardiac or other major surgery or transient ischemic attack or stroke within 2 months (3 months of stabilization after CRT or cardiac surgery);
• −Scheduled cardiac surgery;