Early Feasibility Study - Edwards APTURE Transcatheter Shunt System
- Conditions
- Heart Failure
- Interventions
- Device: Transcatheter Atrial Shunt System
- Registration Number
- NCT03523416
- Lead Sponsor
- Edwards Lifesciences
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 71
-
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
-
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
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Mean Right Atrial Pressure (mRAP) > 15 mmHg at rest
-
Body Mass Index (BMI) ≥ 45 kg/m2
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Edwards Transcatheter Atrial Shunt System Transcatheter Atrial Shunt System -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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)
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)
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)
Trial Locations
- Locations (15)
UC San Diego Health
🇺🇸La Jolla, California, United States
University California San Francisco
🇺🇸San Francisco, California, United States
University of Florida Health - Jacksonville
🇺🇸Jacksonville, Florida, United States
St. Vincent Medical Group
🇺🇸Indianapolis, Indiana, United States
Kansas University Medical Center
🇺🇸Kansas City, Kansas, United States
Abbott Northwestern
🇺🇸Minneapolis, Minnesota, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Atrium Health
🇺🇸Charlotte, North Carolina, United States
The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
The Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Lankenau Institute for Medical Research
🇺🇸Wynnewood, Pennsylvania, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States