APTURE transcatheter shunt: Transcatheter treatment of symptomatic left heart failure patients
Study summary
The Exploratory study of the Edwards APTURE transcatheter shunt system (APTURE system) is a multi-center, prospective, exploratory study to evaluate initial clinical safety, device functionality, and effectiveness of the APTURE system.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Symptomatic HF:
* NYHA II w/ history of \> II; III; or ambulatory IV AND
* ≥1 HF hospitalization OR treatment with IV or oral diuresis within 12 months OR Elevated NT-proBNP value \> 150 pg/ml in normal sinus rhythm, \>450 pg/ml in atrial fibrillation, OR a BNP value \> 50 pg/ml in normal sinus rhythm, \> 150 pg/ml in atrial fibrillation within the past 6 months prior to study entry
* On stable GDMT for HF
* Left Ventricular Ejection Fraction (LVEF) ≤ 40% as determined by site cardiologist
* Hemodynamic criteria
o At rest: Elevated LAP (or PCWP) \> 15 mmHg AND LAP \> RAP + 5 mmHg AND/OR supine ergometer exercise: elevated LAP (or PCWP) \> 25 mmHg AND LAP \> RAP + 10 mmHg
* Pulmonary Vascular Resistance (PVR) \< 5.0 WU as determined by site cardiologist
Exclusion Criteria
* Severe HF:
* NYHA IV, stage D, non-ambulatory, transplant list
* Cardiac index ≤ 1.5 L/min/m2
* Left Ventricular End-Diastolic Diameter (LVEDD) \> 8 cm
* LVEF \<20%
* Valve disease
* MR \>3+ or \> moderate MS, TR \>3+ (severe on 5-point scale), AR \>2+,
* OR \> moderate AS
* MI or therapeutic invasive cardiac procedure \< 3 months
* TIA, stroke, CRT implanted \< 6 months
* RV dysfunction \> mild by TTE OR TAPSE \<1.2 OR RV size ≥ LV size by TTE, OR Right Ventricular Fractional Area Change (RVFAC) ≤ 25%
* Dialysis OR renal dysfunction (S-Cr \> 220 micromol/L OR e-GFR \< 25ml/min/1.73 m2)
* 6MWT \<50m OR \>400m
* Active endocarditis or infection \< 3 months
* Mean Right Atrial Pressure (mRAP) \> 15 mmHg as determined by site cardiologist
* Body Mass Index (BMI) ≥ 45 kg/m2
Primary outcome measure(s)
Rate of major cardiac/cerebrovascular/renal events and re-intervention (Safety Endpoint) — 30 Days Composite of major adverse cardiac, cerebrovascular, renal events (MACCRE) and re-intervention for study device related complications at 30 days.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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