NCT04000607

Brief Summary

The Exploratory study of the Edwards APTURE transcatheter shunt system (APTURE system) is a multi-center, prospective, exploratory study to evaluate initial clinical safety, device functionality, and effectiveness of the APTURE system.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
30mo left

Started Jul 2019

Longer than P75 for not_applicable heart-failure

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Jul 2019Nov 2028

First Submitted

Initial submission to the registry

June 24, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 27, 2019

Completed
13 days until next milestone

Study Start

First participant enrolled

July 10, 2019

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2023

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2028

Expected
Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

4.3 years

First QC Date

June 24, 2019

Last Update Submit

January 23, 2026

Conditions

Heart Failure

Outcome Measures

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.

    30 Days

Secondary Outcomes (8)

  • Rate at which device is successfully implanted (Device Success)

    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)

    10 Days post-op

  • Rate at which the procedure is successful without major cardiac/cerebrovascular/renal events and re-intervention (Clinical Success)

    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 pulmonary capillary wedge pressure (PCWP) from Baseline to Follow Up

    3 Months, 6 Months

  • +3 more secondary outcomes

Study Arms (1)

Edwards APTURE transcatheter shunt system

EXPERIMENTAL
Device: APTURE transcatheter shunt

Interventions

APTURE transcatheter shuntDEVICE

Transcatheter treatment of symptomatic left heart failure patients

Edwards APTURE transcatheter shunt system

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic HF:
  • NYHA II w/ history of \> II; III; or ambulatory IV AND
  • ≥1 HF hospitalization OR treatment with IV or oral diuresis within 12 months OR Elevated NT-proBNP 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 GDMT for HF
  • Left Ventricular Ejection Fraction (LVEF) ≤ 40% as determined by site cardiologist
  • Hemodynamic criteria
  • o At rest: Elevated LAP (or PCWP) \> 15 mmHg AND LAP \> RAP + 5 mmHg AND/OR supine ergometer exercise: elevated LAP (or PCWP) \> 25 mmHg AND LAP \> RAP + 10 mmHg
  • Pulmonary Vascular Resistance (PVR) \< 5.0 WU as determined by site cardiologist

You may not qualify if:

  • Severe HF:
  • NYHA IV, stage D, non-ambulatory, transplant list
  • Cardiac index ≤ 1.5 L/min/m2
  • Left Ventricular End-Diastolic Diameter (LVEDD) \> 8 cm
  • LVEF \<20%
  • Valve disease
  • MR \>3+ or \> moderate MS, TR \>3+ (severe on 5-point scale), 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 \> 220 micromol/L OR e-GFR \< 25ml/min/1.73 m2)
  • MWT \<50m OR \>400m
  • Active endocarditis or infection \< 3 months
  • Mean Right Atrial Pressure (mRAP) \> 15 mmHg as determined by site cardiologist
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2019

First Posted

June 27, 2019

Study Start

July 10, 2019

Primary Completion

November 3, 2023

Study Completion (Estimated)

November 11, 2028

Last Updated

January 27, 2026

Record last verified: 2026-01

Locations

CA(2)