Heart Failure
Conditions
Brief summary
The purpose of this study is to evaluate initial clinical safety, device functionality and effectiveness of the Edwards Transcatheter Atrial Shunt System.
Detailed description
The early feasibility study of the Edwards Transcatheter Atrial Shunt System is a multi-center, prospective, early feasibility study to evaluate initial clinical safety, device functionality, and effectiveness of the Edwards Transcatheter Atrial Shunt System.
Interventions
DEVICETranscatheter Atrial Shunt System
Transcatheter treatment of symptomatic left heart failure patients
Sponsors
Edwards Lifesciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate at which device is patent and subject is discharged from hospital without the need for additional intervention for the device (Procedural Success) | 10 days post-op | Device success with evidence of shunt patency and hospital discharge without the need for additional surgical or percutaneous intervention related to the study device including unacceptable Qp/Qs values. |
| Rate at which the procedure is successful without major cardiac/cerebrovascular/renal events and re-intervention (Clinical Success) | 30 days | Procedural success without major adverse cardiac, cerebrovascular, and renal events (MACCRE) and re-intervention for study device related complications at 30 days. |
| Change in the ratio of systemic blood flow (Qs) to the pulmonary blood flow (Qp), called Qp/Qs, from Baseline to Follow Up | 3 months, 6 months | Change in Qp/Qs value from Baseline to Follow Up (3Month, 6Month) |
| Rate at which device is successfully implanted (Device Success) | Day 0 | Device is deployed as intended and the delivery system is successfully removed as intended at the time of the patient's exit from the implant procedure room. |
| Change in mean systolic & diastolic pulmonary artery pressure (PAP) and change in mean right atrial pressure (RAP) from Baseline to Follow Up | 3 months, 6 months | Change in PAP and RAP values from Baseline to Follow Up (3Month, 6Month) under the same test conditions (e.g. comparison in the value at rest at baseline, to at rest at follow up; comparison in the value at exercise at baseline, to at exercise at follow up) |
| Change in Pulmonary Vascular Resistance (PVR) from Baseline to Follow Up | 3 months, 6 months | Change in PVR value from Baseline to Follow Up (3Month, 6Month) under the same test conditions (e.g. comparison in the value at rest at baseline, to at rest at follow up; comparison in the value at exercise at baseline, to at exercise at follow up) |
| Change in two parameters related to Tricuspid Annular Plane Excursion (TAPSE) from Baseline to Follow Up | 3 months, 6 months | Change in two parameters from Baseline to Follow Up (3Month, 6Month): 1. TAPSE, Tricuspid Annular Plane Excursion 2. TAPSE/sPAP, Tricuspid Annular Plane Excursion (TAPSE) divided by the systolic pulmonary Artery Pressure (sPAP) |
| Change in pulmonary capillary wedge pressure (PCWP) from Baseline to Follow Up | 3 months, 6 months | Change in PCWP value from Baseline to Follow Up (3Month, 6Month) |
Countries
United States
Outcome results
None listed