Exploratory Study of the Edwards APTURE Transcatheter Shunt System (ALT-FLOW Canada)

Launched by EDWARDS LIFESCIENCES · Jun 25, 2019

Keywords

ClinConnect Summary

The Exploratory Study of the Edwards APTURE Transcatheter Shunt System is looking at a new device designed to help patients with heart failure. This study aims to see how safe the APTURE system is, how well it works, and its effectiveness in treating heart failure symptoms. It is important to note that the study is currently active but not recruiting new participants.

To be eligible for this study, participants need to be between the ages of 65 and 74 and must have symptomatic heart failure, meaning they experience symptoms that affect their daily life, such as shortness of breath or fatigue. They should also have a specific heart function metric, known as Left Ventricular Ejection Fraction (LVEF), of 40% or less. Candidates must be receiving stable treatment for heart failure and meet certain health criteria, but those with severe heart failure or certain heart conditions may not qualify. Participants can expect to undergo regular check-ups and assessments to monitor their health while using the APTURE system, contributing valuable information to help improve treatment options for heart failure in the future.

Gender

ALL

Eligibility criteria

• 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