Multicenter, Prospective, Open Label, Single Arm, Clinical Trial. The primary objective of this clinical trial is to further evaluate the safety and clinical efficacy of the IASD System II in symptomatic heart failure patients with an left ventricular ejection fraction (LVEF) ≥ 40%, and elevated left sided filling pressures despite standard Guideline Directed Medical Therapy (GDMT); and to compare the safety and efficacy results to those from the treatment arm of the REDUCE LAP-HF Randomized Trial II (Corvia protocol 1601).
Participants are screened against non-invasive eligibility criteria and scheduled for a hemodynamic evaluation. Following right heart catheterization at rest and during supine bicycle exercise, patients will undergo a brief intracardiac echocardiography (ICE) or transesophageal echocardiography (TEE) exam for septal suitability. Eligible patients continue with, fluoroscopically and echo guided transseptal puncture and IASD System II implant procedure. If a previously unknown protocol exclusion is discovered during the index procedure, and device is not implanted, participant is followed for 30 days, and then exits the study. Participants return for follow-up exams 30 days after the implant procedure and annually for 5 years after the implant procedure. In-person visits will take place for the first 2 years. Telephone follow-up and medical chart review will be conducted for years 3-5.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
The implant is placed across the interatrial septum using a percutaneous transcatheter approach.
Incidence of and time-to-cardiovascular mortality or first non-fatal, ischemic stroke through 12 months
Time frame: 12 Month
Total rate (first plus recurrent) per patient year of heart failure (HF) admissions or healthcare facility visits for IV diuresis for HF up to 24 months, analyzed when the last subject completes 12 month follow-up, and time-to-first HF event
Time frame: Up to 24 Months
Change in baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) total summary score at 12 months
Time frame: 12 Month
Cardiovascular mortality through 12 months
Time frame: 12 Months
Non-fatal, ischemic stroke through 12 months
Time frame: 12 Months
New onset or worsening of kidney dysfunction (defined as eGFR decrease of > 20 ml/min/1.73 m2) through 12 months
Time frame: 12 Months
Incidence of Major Cardiac Events i. Cardiac death ii. Myocardial infarction iii. Cardiac tamponade iv. Emergency cardiac surgery.
Time frame: 12 Months
Thrombo-embolic complications (TIA, systemic embolization) through 12 months
Time frame: 12 Months
≥30% increase in right ventricular size/decrease in TAPSE through 12 months
Time frame: 12 Months
Newly acquired persistent or permanent AF or atrial flutter through 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 12 Months
Total rate per patient year of heart failure admissions or healthcare facility visits for IV diuresis or visits with intensification of oral diuresis for HF through 24 months, analyzed when the last subject completes 12 months follow-up
Time frame: Up to 24 months
Change in New York Heart Association (NYHA) functional Class between baseline and 12 months
Time frame: 12 Months
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score between baseline and 12 months, categorized as ≤0, >0 - 5, >5 - 10, >10 - 15, >15 - 20, >20 - 25, >25.
Time frame: 12 Months