Phase
Condition
Chest Pain
Heart Disease
Stress
Treatment
HS135
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients are eligible to be included in the study only if they meet at least all the following criteria:
Male or female, >18 years of age.
CardioMEMS™ Heart Failure System implanted during standard of care at least 90 daysbefore Screening.
Established diagnosis of HFpEF with Left Ventricular Ejection Fraction (LVEF) atleast 45% as measured by echocardiography during Screening.
New York Heart Association (NYHA) class II, III or IV heart failure symptoms.
BMI ≥ 30 kg/m2.
Ability to adhere to study visit schedule and understand and comply with allprotocol requirements.
Exclusion
Exclusion Criteria:
Patients will be excluded from the study if they meet any of the following criteria:
Decompensated heart failure.
Admission for an acute coronary syndrome, percutaneous coronary intervention, orcardiac surgery within 30 days prior to Screening.
Implantation of cardiac resynchronization therapy (CRT) device within 90 days priorto Screening.
Planned cardiovascular revascularization or major cardiac surgery or plannedimplantation of CRT device.
History of heart transplant or on heart transplant list.
Uncontrolled systemic hypertension.
Patients who have an abnormality in echocardiography or electrocardiogram that inthe opinion of the investigator increases the risk of participating in the study.
Patients who have full pneumonectomy or a severe chronic pulmonary disorder that inthe opinion of the investigator increases the risk of participating in the study.
Study Design
Study Description
Connect with a study center
Site-104
Phoenix, Arizona 85016
United StatesActive - Recruiting
Site-105
Kansas City, Missouri 64111
United StatesSite Not Available
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