This pilot study will evaluate the efficacy and safety of CCM therapy in heart failure patients with baseline EF≥50% (HFpEF) who have New York Heart Association (NYHA) Class II or III symptoms despite appropriate medication. The terminology of the HF classification HFpEF is based on the 2016 European Society of Cardiology (ESC) Heart Failure Guidelines.
This is a pilot clinical study of CCM in addition to optimal medical therapy (OMT) over a 24 week period.The primary endpoint shall be mean change from baseline to 24 weeks in Kansas City Cardiomyopathy Questionnaire (KCCQ) overall score (reflecting integrated information on physical limitations, symptoms, self-efficacy, social interference and quality of life). This pilot study will collect efficacy and safety data in heart failure patients having NYHA class II and III symptoms despite appropriate medication with baseline ejection fraction equal or greater than 50% (HFpEF populations).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
47
Cardiac Contractility Modulation
Friendly Society Private Hospital
Bundaberg, Queensland, Australia
St. John of God Bunbury
Bunbury, Australia
KCCQ change
Mean change from baseline to 24 weeks in Kansas City Cardiomyopathy Questionnaire (KCCQ) overall score
Time frame: 24 weeks
Echocardiography
LAVi and diastolic function: septal E' velocity, septal E/E' ratio
Time frame: 24 weeks
NT-proBNP
Mean Change in 24 weeks
Time frame: 24 weeks
NYHA class
Mean Change in 24 weeks
Time frame: 24 weeks
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