Early Feasibility Study of the Edwards APTURE Transcatheter Shunt System

ConditionHeart Failure

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorEdwards Lifesciences

About this trial

The objectives of this early feasibility study are to: evaluate initial clinical safety, device functionality, and effectiveness of the APTURE system for treatment of symptomatic HFrEF patients with elevated LAP, provide guidance for future clinical study and system designs utilizing the APTURE system.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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
Device
Transcatheter treatment of symptomatic heart failure patients with elevated left atrial pressure (LAP).

Treatment groups

15 Participants

are divided into 1 treatment group

Group A: Edwards APTURE transcatheter shunt systemExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Rate of major cardiac/cerebrovascular/renal events and re-intervention (Safety Endpoint)

Composite of device- or procedure-related major adverse cardiovascular, cerebrovascular, and renal events (MACCRE) at 30 days post implant procedure or hospital discharge, whichever is later.

Time frame

30 days

Secondary outcomes

Change in KCCQ Overall Summary Score (Performance Endpoint)

Change in KCCQ-OSS from baseline to 6 months.

Time frame

6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Edwards Lifesciences

Lead sponsor

Source ClinicalTrials.gov

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