In This SectionTexas Health Research & Education Institute
Disease or Condition
This study will look at whether an electrical treatment may keep patients with heart failure from getting worse.
Patient has diagnosis of chronic heart failure5 > 90 days in duration.
Patient has left ventricular ejection fraction (LVEF) between 36% and 50%, inclusive, as documented at baseline or within 30 days prior to enrollment.
Patient is either:
- NYHA Class III at enrollment or at baseline OR
- NYHA Class II at enrollment or at baseline, with a documented hospitalization for HF in the 12 months prior to enrollment OR
- NYHA Class II at enrollment or at baseline, without a documented hospitalization for HF in the prior 12 months, but with BNP =250 pg/ml or NT-proBNP =1000 pg/ml (documented within 30 days prior to enrollment or at
Note: NYHA Functional Class II or III must be confirmed by a qualified individual not involved with the study (cardiologist or other physician or appropriately
credentialed heart failure clinician/nurse) within 30 days prior to enrollment or during the baseline assessment.
Patient has documented left bundle branch block (LBBB) with QRS =130ms at baseline or within 30 days prior to enrollment.
Patient is in sinus rhythm at time of enrollment or at the baseline visit.
Patient has had no additions to or subtractions from non-diuretic heart failure medical therapy within 30 days prior to enrollment.
For patients with LVEF =40%, must be on optimal medical therapy at maximum tolerated doses, defined as:
- ACE-inhibitor (Angiotensin-Converting Enzyme) or Angiotensin II Receptor Blocker (ARB), if tolerated, for at least 30 days prior to enrollment, and
- Beta blocker for at least 90 days preceding enrollment, if tolerated, and stable for 30 days. Stable is defined as no upward titration of beta blockers.
- If aldosterone antagonist (AA) therapy is prescribed, it must be initiated and on stable dosage for 30 days prior to enrollment.
Note: Therapeutic equivalence for ACE-I substitutions is allowed within the enrollment stability timeline of 30 days.
For patients with ischemic heart disease, the following medications must be at maximum tolerated dose for 30 days prior to enrollment:
- ACE inhibitors in all subjects with left ventricular ejection fraction =40% and in those with hypertension, diabetes, or chronic kidney disease, unless
- Beta blockers in all subjects who have had myocardial infarction, acute coronary syndrome, or left ventricular dysfunction with or without heart failure symptoms, unless contraindicated.
- Antiplatelet therapy.
- Lipid-lowering therapy in subjects with documented or suspected CAD and LDL cholesterol >130 mg/dL with a target LDL of <100 mg/dL.56
For patients with systemic hypertension, the following medications must be at maximum tolerated dose for 30 days prior to enrollment:
- Beta blockers and/or ACE inhibitors in subjects with blood pressure >140/90 mm Hg (or >130/80 mm Hg for individuals with chronic kidney disease or diabetes), with the addition of other drugs as needed to achieve goal blood pressure.
- A patient whose pressures remain elevated should be maximized on three antihypertensive medications of different classes, including one diuretic, (i.e. “refractory” hypertension) prior to enrollment.
For patients with a history of paroxysmal atrial fibrillation, medications should be managed based on current guideline recommendations as appropriate:
- If a rate control medication is prescribed, must be at optimal dose for 30 days prior to enrollment.
- Anticoagulant per physician discretion in patients who are not contraindicated.
Patient or patient’s legally authorized representative or guardian has signed and dated the study informed consent.
Patient is able to receive a pectoral CRT-P implant.
Patient is expected to remain available for follow-up visits.
Patient is willing and able to comply with the Clinical Investigation Plan.
Patient requires permanent cardiac pacing.
Patient is indicated for implantable cardioverter defibrillator (ICD), such as for secondary prevention of prior sudden cardiac arrest, related to prior history of ventricular tachycardia and/or ventricular fibrillation.
Patient is <18 years of age, or under a higher minimum age requirement as defined by local law.
Patient has experienced unstable angina or an acute MI within 40 days prior to enrollment.
Patient has had coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) within the 90 days prior to enrollment.
Patient has chronic (permanent) atrial arrhythmias. Chronic (permanent) atrial arrhythmias are defined as cases of long-standing atrial fibrillation (e.g., greater than 1 year) in which cardioversion has not been indicated or attempted.
Patient has had cardioversion for atrial fibrillation within the past 30 days prior to enrollment.
Patient has had a treatable pericardial constraint in the past 30 days prior to enrollment.
Patient has restrictive (infiltrative) cardiomyopathies, such as amyloidosis, sarcoidosis, or hemochromatosis.
Patient is enrolled in a concurrent study, with the exception of a study-manager approved study that is strictly observational in nature and does not confound the results of this study (e.g. registries).
Patient has a life expectancy of less than 24 months due to non-cardiac conditions.
Female patient who is pregnant, or of childbearing potential and not on a reliable form of birth control. Women of childbearing potential are required to have a negative
pregnancy test within the seven (7) days prior to device implant.
Patient has a CRT-P, pacemaker, ICD or CRT-D device implanted previously, or currently.
Patient has restrictive, hypertrophic, or reversible cardiomyopathy.
Patient has a mechanical right heart valve.
Patient has primary valvular disease and is indicated for valve repair or replacement.
Patient has had a heart transplant, or is currently on a heart transplant list.
Patient has significant renal dysfunction, as manifested by serum creatinine level >2.5 mg/dl or =275 µmol/L or estimated glomerular filtration rate (GFR) =30 mL/min/1.73 m2, which is documented within the 30 days prior to enrollment or at baseline.
Patient has significant hepatic dysfunction, as evidenced by a hepatic function panel (serum) > 3 times upper limit of normal, which is documented within the 30 days prior to enrollment or at baseline.
Patient has chronic or treatment-resistant severe anemia (hemoglobin <10.0 g/dL), which is documented within the 30 days prior to enrollment or at baseline.