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Heart FailureNCT04000607

Exploratory Study of the Edwards APTURE Transcatheter Shunt System (ALT-FLOW Canada)

A study testing APTURE transcatheter shunt in people with Heart Failure, run by Edwards Lifesciences at 2 sites in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
APTURE transcatheter shunt
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
2 sitesCanada
Study dates
10 Jul 2019to 11 Nov 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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)
  • 6MWT <50m OR >400m
  • Active endocarditis or infection < 3 months
  • Mean Right Atrial Pressure (mRAP) > 15 mmHg as determined by site cardiologist
  • Body Mass Index (BMI) ≥ 45 kg/m2

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • University of Ottawa Heart Institute

    Ottawa, Ontario

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

Other trials in Canada

About this study

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.

Conditions
Heart Failure
Being tested
APTURE transcatheter shunt
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • APTURE transcatheter shuntDevice

    Transcatheter treatment of symptomatic left heart failure patients

Study groups in NCT04000607
Study groupRoleWhat they receive
Edwards APTURE transcatheter shunt systemExperimentalNot described
Receives: Device: APTURE transcatheter shunt

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 30 Days

Secondary outcomes (8)

  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.

    Measured: Day 0

  2. 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.

    Measured: 10 Days post-op

  3. 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.

    Measured: 30 Days

  4. 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)

    Measured: 3 Months, 6 Months

  5. Change in pulmonary capillary wedge pressure (PCWP) from Baseline to Follow Up

    Change in PCWP value from Baseline to Follow Up (3Month, 6Month)

    Measured: 3 Months, 6 Months

  6. 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)

    Measured: 3 Months, 6 Months

  7. 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)

    Measured: 3 Months, 6 Months

  8. 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)

    Measured: 3 Months, 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2019
  2. Study start10 Jul 2019
  3. Primary completion3 Nov 2023
  4. Study completion11 Nov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04000607
Sponsor's protocol ID
2018-11
Status last verified
Jan 2026
First submitted
24 Jun 2019
Last updated
27 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing APTURE transcatheter shunt in people with Heart Failure, run by Edwards Lifesciences at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of major cardiac/cerebrovascular/renal events and re-intervention (Safety Endpoint) (time frame: 30 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04000607.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.

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