Early Feasibility Study - Edwards APTURE Transcatheter Shunt System
ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEdwards Lifesciences
About this trial
The purpose of this study is to evaluate initial clinical safety, device functionality and effectiveness of the Edwards APTURE transcatheter shunt system.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
A primary diagnosis of HFrEF (LVEF ≤ 40%), and
NYHA Class II, III, or IVa heart failure symptoms and
Hospitalization for heart failure; or
Increased treatment for heart failure, including intravenous (IV) or higher-dose diuretic therapy.
Disqualifiers
Ambulatory NT-proBNP value >5,000 pg/ml or BNP value >1,600 pg/ml
Left ventricular end-diastolic diameter (LVEDD) >8 cm
Left ventricular ejection fraction (LVEF) < 20%
ACC/AHA Stage D HF or non-ambulatory NYHA Class IV HF
Trial design
Design model
Single group
Treatments tested in this trial
Edwards APTURE transcatheter shunt system
DeviceTranscatheter treatment of symptomatic heart failure patients with elevated left atrial pressure.
Treatment groups
90 Participants
are divided into 1 treatment groupGroup A: Edwards APTURE transcatheter shunt systemExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 daysSecondary outcomes
1
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 02
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-op3
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, renal events (MACCRE), and re-intervention for study device related complications at 30 days.
Time frame
30 days4
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 monthsOther outcomes
1
HFrEF Subgroup Analysis
Data obtained from the refined HFrEF subgroup will be analyzed according to the endpoints defined above, based on measurements available across all follow-up time points.
Time frame
10 days post-op, 30 days, 3 months, 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov