Clinical Trials

INCLUSION CRITERIA:

• Chronic symptomatic heart failure (HF) documented by the following:
  • Symptoms of HF requiring current treatment with diuretics for ≥ 30 days; AND
  • New York Heart Association (NYHA) class II if a prior history of > NYHA class II; OR
  • NYHA class III, or ambulatory NYHA class IV symptoms (paroxysmal nocturnal dyspnea, orthopnea, dyspnea on mild or moderate exertion) at screening visit; or signs (any rales post cough, chest x-ray demonstrating pulmonary congestion,) within past 12 months; AND
  • ≥ 1 HF hospital admission (with HF as the primary, or secondary diagnosis); OR
  • Treatment with intravenous (IV); or the need for intensification of oral diuresis for HF in a healthcare facility within the 12 months prior to study entry; OR
  • An NT-pro BNP value > 150 pg./ml in normal sinus rhythm, > 450 pg./ml in atrial fibrillation, or a BNP value > 50 pg./ml in normal sinus rhythm, > 150 pg./ml in atrial fibrillation within the past 6 months.
• Ongoing stable GDMT HF management and management of potential comorbidities according to the 2017 ACC/AHA Guidelines for the Management of Heart Failure with no significant changes (>100% increase or 50% decrease), excluding diuretic dose changes for a minimum of 4 weeks prior to enrollment which is expected to be maintained for 6 months. Stable management includes a minimum period of 4 weeks post hospitalization for any cause, including treatment with IV diuretics.
• Age ≥ 40 years old.
• Site determined echocardiographic LV ejection fraction ≥ 40% within the past 6 months, without documented ejection fraction <30% in the 5 years prior to study entry.
• Site determined elevated PCWP with a gradient compared to right atrial pressure (RAP) documented by a. End-expiratory PCWP during supine ergometer exercise ≥ 25mm Hg, and greater than RAP by ≥ 5 mm Hg.
• Site determined echocardiographic evidence of diastolic dysfunction documented by one or more of the following:
  • LA diameter > 4 cm; or
  • Diastolic LA volume > 50, LA volume index > 28 ml/m2; or
  • Lateral e’ < 10 cm/s; or
  • Septal e’ < 8 cm/s; or
  • Lateral E/e’ > 10; or
  • Septal E/e’ > 15.
• Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the IRB or EC.
• Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams.
• Trans-septal catheterization and femoral vein access is determined to be feasible by site interventional cardiology investigator.

EXCLUSION CRITERIA:

• MI and/or percutaneous cardiac intervention within past 3 months; CABG in past 3 months, or current indication for coronary revascularization; AVR (surgical AVR or TAVR) within the past 12 months; or a planned cardiac interventions in the 3 months following enrollment.
• Cardiac resynchronization therapy initiated within the past 6 months.
• Advanced heart failure defined as one or more of the below:
  • ACC/AHA/ESC Stage D heart failure, Non-ambulatory NYHA Class IV HF;
  • Cardiac Index < 2.0 L/min/m2;
  • Inotropic infusion (continuous or intermittent) for EF < 40% within the past 6 months;
  • Patient is on the cardiac transplant waiting list.
• Inability to perform 6 minute walk test (distance < 50 m), OR 6 minute walk test > 600m
• The patient has verified that the ability to walk 6 minutes is limited primarily by joint, foot, leg, hip or back pain; unsteadiness or dizziness or lifestyle (and not by shortness of breath and/or fatigue and/or chest pain).
• Unwilling or unable (per PhysIQ protocol) to wear telemonitoring patch.
• Known clinically significant un-revascularized coronary artery disease, defined as: epicardial coronary artery stenosis with angina or other evidence of ongoing active coronary ischemia.
• History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 6 months.
• Known clinically significant untreated carotid artery stenosis likely to require intervention.
• Presence of hemodynamically significant valve disease assessed by the site cardiologist and defined as:
  • Mitral valve disease defined as grade ≥ 3+ MR or > mild MS; OR
  • Tricuspid valve regurgitation defined as grade ≥ 2+ TR; OR
  • Aortic valve disease defined as ≥ 2+ AR or > moderate AS.
• Hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis or other infiltrative cardiomyopathy (e.g. hemochromatosis, sarcoidosis)
• Subject is contraindicated to receive either dual antiplatelet therapy, or an oral anticoagulant; or has a documented coagulopathy
• Atrial fibrillation with resting HR > 100 BPM
• Resting arterial oxygen saturation < 95% on room air
• Significant hepatic impairment defined as 3X upper limit of normal of transaminases, total bilirubin, or alkaline phosphatase
• Right ventricular dysfunction, assessed by the site cardiologist and defined as:
  • More than mild RV dysfunction as estimated by TTE; OR
  • TAPSE < 1.4 cm; OR
  • RV size ≥ LV size as estimated by TTE; OR
  • Ultrasound or clinical evidence of congestive hepatopathy; OR
  • Evidence of RV dysfunction defined by TTE as an RV fractional area change < 35%.
• Resting RAP > 14 mmHg.
• Evidence of significant pulmonary hypertension defined as PVR > 3.5 Woods units at rest or at peak exercise.
• Chronic pulmonary disease requiring continuous home oxygen, OR significant chronic pulmonary disease defined as FEV1 < 1L.
• Hemoglobin <10 g/dl.
• Currently participating in an investigational drug or device study that would interfere with the conduct or results of this study. Note: trials requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational.
• Life expectancy less than 12 months for known non-cardiovascular reasons.
• Echocardiographic evidence of intra-cardiac mass, thrombus or vegetation.
• Known or suspected allergy to nickel.
• Women of child bearing potential.
• Currently requiring dialysis; or estimated-GFR < 25ml/min/1.73 m2 by CKD-Epi equation.
• Systolic blood pressure > 170 mm Hg at screening .
• Subjects with existing or surgically closed (with a patch) atrial septal defects. Subjects with a patent foramen ovale (PFO), who meet PCWP criteria despite the PFO, are not excluded.
• Subjects on significant immunosuppressive treatment or on systemic steroid treatment (>10 mg prednisone/day).
• Severe obstructive sleep apnea not treated with CPAP or other measures.
• Severe depression and/or anxiety.
• In the opinion of the investigator, the subject is not an appropriate candidate for the study.
• BMI > 45. BMI 40 - 45 is also excluded unless in the opinion of the investigator, vascular access can be obtained safely.