Ensayos clínicos

Inclusion Criteria

• Subjects ≥ 40 years of age.
• Chronic heart failure defined as:
  • Symptoms of HF requiring current treatment with diuretics for > 30 days; AND
  •  
  • NYHA class II with a history of > NYHA class II in the past year, NYHA class III, or ambulatory NYHA class IV symptoms (paroxysmal nocturnal dyspnea, orthopnea, dyspnea on mild or moderate exertion) at screening; or signs of HF (any rales post cough, chest x-ray demonstrating pulmonary congestion); AND
• At least one of the following:
  • ≥ 1 HF hospital admission (with HF as the primary, or secondary diagnosis) within the 12 months prior to study entry;
  • Treatment with intravenous (IV) diuretics, or intensification of oral diuresis for HF in a healthcare facility within the 12 months prior to study entry;
  • NT-pro BNP value > 150 pg/ml in normal sinus rhythm, > 450 pg/ml in atrial fibrillation within the past 6 months;
  • 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 (unless unable to tolerate GDMT) and management of potential comorbidities according to the 2017 ACCF/AHA Guideline for the Management of Heart Failure, with no significant changes [>100% increase or 50% decrease] for a minimum of 1 month prior to screening, that is expected to be maintained without change for at least 3 months.
• LVEF ≥ 50% (site determined by TTE) within the past 6 months.
• Site determined elevated PCWP documented by right heart catheterization with end-expiratory PCWP ≥ 25 mmHg during supine ergometer exercise on the day of the Index procedure or within 24-48 hours of Index procedure.
• Subject is willing and able to provide appropriate study-specific informed consent, follow protocol procedures, and comply with follow-up visit requirements.

Exclusion Criteria:

• MI (type I) and/or percutaneous cardiac intervention within 3 months prior to screening, CABG in past 3 months prior to screening, or current indication for coronary revascularization.
• Cardiac resynchronization therapy initiated within 3 months prior to screening.
• 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/m^2;
  • Inotropic infusion (continuous or intermittent) for LV EF< 30% within 6 months prior to screening;
  • Subject is on the cardiac transplant waiting list.
• BMI > 45 kg/m^2.
• 6-minute walk test distance < 100 meters OR distance > 450 meters.
• Admission for HF within the 30 days prior to planned index procedure.
• In the last 3 years an ejection fraction below 40%
• Systolic BP < 100 mmHg or > 170 mmHg despite appropriate medical management.
• Symptomatic orthostatic hypotension or orthostatic hypotension requiring treatment (orthostatic hypotension is defined as a systolic blood pressure decrease of > 20mmHg and/or increase in heart rate > 20 bpm upon going from supine to standing position).
• Arterial oxygen saturation < 90 % on room air.
• Presence of significant valve disease defined by the site cardiologist as:
  • Greater than mild mitral valve stenosi;
  • Greater than moderate mitral valve regurgitation;
  • Greater than moderate to severe tricuspid valve regurgitation;
  • Greater than moderate aortic valve disease.
• MI (type I) and/or percutaneous cardiac intervention within 3 months prior to screening; CABG in past 3 months prior to screening, or current indication for coronary revascularization.
• Cardiac resynchronization therapy initiated within 3 months prior to screening.
• Advanced heart failure defined as one or more of the below:
  1. ACC/AHA/ESC Stage D heart failure, non-ambulatory NYHA Class IV HF
  2. Cardiac index < 2.0 L/min/m2
  3. Inotropic infusion (continuous or intermittent) for LV EF< 30% within 6 months prior to screening
  4. Subject is on the cardiac transplant waiting list
• BMI > 45 kg/m2
• 6-minute walk test distance < 100 meters OR distance > 450 meters.
• Admission for HF within the 30 days prior to planned index procedure.
• In the last 3 years an ejection fraction below 40%
• Systolic BP < 100 mmHg or > 170 mmHg despite appropriate medical management.
• Symptomatic orthostatic hypotension or orthostatic hypotension requiring treatment (orthostatic hypotension is defined as a systolic blood pressure decrease of >20mmHg and/or increase in heart rate >20 bpm upon going from supine to standing position).
• Arterial oxygen saturation < 90 % on room air.
• Presence of significant valve disease defined by the site cardiologist as:
  • Greater than mild mitral valve stenosis.;
  • Greater than moderate mitral valve regurgitation;
  • Greater than moderate to severe tricuspid valve regurgitation;
  • Greater than moderate aortic valve disease.
• Hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis, or other infiltrative cardiomyopathy (e.g., hemochromatosis, sarcoidosis).
• Vessel tortuosity or variant vascular anatomy or IVC filter that could preclude the access or maneuvering of the interventional device from the access site to target vessel.  This includes previous spine surgery that may impact the ability to access and treat the target sites of T11 and T10.
• Mean right resting atrial pressure (RAP) > 20 mmHg based upon screening right heart catheterization.
• History of clinically significant liver cirrhosis.
• Dialysis dependent; or estimated-GFR < 25 ml/min/1.73 m^2 by CKD-EPI creatinine equation.
• Baseline status ECG with atrial fibrillation with resting HR >100 beats per minute.
• Chronic pulmonary disease requiring continuous home oxygen OR hospitalization  for exacerbation (including intubation) in the 12 months before study entry OR known history of GOLD Class III or higher COPD.
• Participating in conflicting investigational drug or device study within 30 days of the screening visit.
• Life expectancy < 12 months for non-cardiovascular reasons.
• Any condition, or history of illness or surgery that, in the opinion of the Investigator, might confound the results of the study or pose additional risks to the patient.
• Females who are pregnant or lactating or planning to become pregnant during the next year.

Eligibility last updated 1/4/22. Questions regarding updates should be directed to the study team contact.