The purpose of this study is to evaluate initial clinical safety, device functionality and effectiveness of the Edwards Transcatheter Atrial Shunt System.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
71
Transcatheter treatment of symptomatic left heart failure patients
UC San Diego Health
La Jolla, California, United States
University California San Francisco
San Francisco, California, United States
Rate of major cardiac/cerebrovascular/renal events and re-intervention (Safety Endpoint)
Composite of major adverse cardiac, cerebrovascular, renal events (MACCRE) and re-intervention for study device related complications at 30 days.
Time frame: 30 days
Rate at which device is successfully implanted (Device Success)
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.
Time frame: Day 0
Rate at which device is patent and subject is discharged from hospital without the need for additional intervention for the device (Procedural Success)
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.
Time frame: 10 days post-op
Rate at which the procedure is successful without major cardiac/cerebrovascular/renal events and re-intervention (Clinical Success)
Procedural success without major adverse cardiac, cerebrovascular, and renal events (MACCRE) and re-intervention for study device related complications at 30 days.
Time frame: 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
Change in Qp/Qs value from Baseline to Follow Up (3Month, 6Month)
Time frame: 3 months, 6 months
Change in pulmonary capillary wedge pressure (PCWP) from Baseline to Follow Up
Change in PCWP value from Baseline to Follow Up (3Month, 6Month)
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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
The Bronx, New York, United States
Atrium Health
Charlotte, North Carolina, United States
The Christ Hospital
Cincinnati, Ohio, United States
...and 5 more locations
Time frame: 3 months, 6 months
Change in mean systolic & diastolic pulmonary artery pressure (PAP) and change in mean right atrial pressure (RAP) from Baseline to Follow Up
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)
Time frame: 3 months, 6 months
Change in Pulmonary Vascular Resistance (PVR) from Baseline to Follow Up
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)
Time frame: 3 months, 6 months
Change in two parameters related to Tricuspid Annular Plane Excursion (TAPSE) from Baseline to Follow Up
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)
Time frame: 3 months, 6 months