Transcatheter Atrial Shunt System: Transcatheter treatment of symptomatic left heart failure patients
Study summary
The purpose of this study is to evaluate initial clinical safety, device functionality and effectiveness of the Edwards Transcatheter Atrial Shunt System.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Symptomatic Heart Failure (HF):
* NYHA class II with a history of \> II; III; or ambulatory IV AND
* ≥ 1 HF hospital admission; or treatment with IV or oral diuresis within 12 months; OR an NT-pro BNP 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 Guideline Directed Medical Therapy (GDMT) for heart failure
* At rest: elevated LAP (or PCWP) of \> 15 mmHg and LAP (or PCWP) exceeds right atrial pressure (RAP) by \> 5 mmHg AND/OR supine ergometer exercise, elevated LA (or PCWP) pressure of \> 25 mmHg and LA (or PCWP) exceeds right atrial pressure (RAP) by \> 10 mmHg
* Left Ventricular Ejection Fraction (LVEF) ≤ 40%
* Pulmonary Vascular Resistance (PVR) \< 4.0 WU
Exclusion Criteria:
* Severe HF:
* Stage D, non-ambulatory NYHA Class IV, transplant list
* If BMI \< 30, Cardiac index \< 2.0 L/min/m2
* If BMI ≥ 30, cardiac index \< 1.8 L/min/m2
* Left Ventricular End-Diastolic Diameter (LVEDD) \> 8 cm
* LVEF \< 20%
* Valve disease: MR \> 3+ or \> moderate MS, TR \> 2+, 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 \> 2.5 mg/dl OR eGFR \< 25 ml/min/1.73m2)
* 6MWT \< 50m OR \> 600m
* Active endocarditis or infection \< 3 months
* Mean Right Atrial Pressure (mRAP) \> 15 mmHg at rest
* 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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.