The objective of this pilot study is to evaluate the safety and performance of implanting the IASD® System II in Heart Failure patients with reduced ejection fraction and elevated left sided filling pressures, who remain symptomatic despite Guideline Directed Medical Therapy (GDMT).
The intended clinical indication of the IASD System II is the reduction of elevated LAP in patients with symptomatic heart failure with reduced ejection fraction, despite appropriate medical management. The implant is designed with a center barrel opening that, in the setting of elevated LAP, allows left to right flow. Since many of the symptoms these patients experience are believed to be due to elevated LAP, the IASD System II has the potential to significantly reduce symptoms and improve the quality of life in patients with otherwise limited treatment options. The study design is a prospective, non-randomized, single-arm feasibility trial. This study will implant up to 10 subjects. The population will include heart failure patients with reduced ejection fraction, and elevated left sided filling pressures, who remain symptomatic despite GDMT, including optimal doses of recommended pharmaceutical treatments, surgical, and device intervention(s) (CRT, AICD, reduction of MRI). After analysis of the 1 month results (including baseline and 1 month Core laboratory echocardiographic and hemodynamic data) of the first 5 implanted patients, a decision will be made to implant an additional 5 patients,
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Single arm for implant
Mt. Sinai Hospital
New York, New York, United States
John Hunter Hospital
New Lambton Heights, New South Wales, Australia
St. Vincent Hospital
Sydney, Australia
Homolka Hospital
Prague, Czechia
The percent of subjects who experience major adverse cardiac and/or cerebrovascular events (MACCE)
The primary endpoint will be peri-procedural, and 6 months Major Adverse Cardiac and Cerebrovascular Events (MACCE) and systemic embolic events in patients implanted with the IASD.
Time frame: 6 months
The percent of subjects who have successful device implantation
Deployment at the intended location during the index procedure
Time frame: Index Procedure
The percent of subjects left to right flow through the device
Left to right flow through the device at 6 months as assessed by an echocardiographic core laboratory
Time frame: 6 months
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