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Heart FailureAlT-FloWNCT04965623

ExplorATory Study oF the EdWards Transcatheter Atrial Shunt System (AlT FloW Germany)

A study testing Atrial Shunt in people with Heart Failure, run by Edwards Lifesciences.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The Exploratory Study of the Edwards Transcatheter Atrial Shunt System is a multi-center, prospective, exploratory study to evaluate initial clinical safety, device functionality, and effectiveness of the Edwards Transcatheter Atrial Shunt 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?
Atrial Shunt
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
22 Feb 2021to 6 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

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

  • Signed and dated Ethics Committee (EC) approved study consent form prior to study related procedures
  • ≥ 18 years old
  • Chronic symptomatic Heart Failure (HF) documented by the following:
  • NYHA class III or ambulatory NYHA class IV within last 12 months AND
  • ≥ 1 HF hospital admission (with HF as the primary, or secondary diagnosis); or treatment with intravenous (IV) or intensification of oral diuresis for HF in a healthcare facility (emergency department/acute care facility) within the 12 months prior to study entry; OR an NT-pro BNP 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.
  • In the judgment of the investigator, subject is on stable Guideline Directed Medical Therapy (GDMT) for heart failure and management of potential comorbidities according to current ACCF/AHA/ESC Guidelines and that is expected to be maintained without change for 3 months
  • Elevated LA (or PCWP) pressure of > 15 mmHg at rest or > 25 mmHg during supine ergometer exercise stress test, as measured at end-expiration; AND the LA (or PCWP) exceeds right atrial pressure (RAP) by > 5 mmHg at rest or > 10 mmHg during supine ergometer exercise stress test as measured at end-expiration
  • Willing to attend study follow-up assessments for up to 5 years

Who cannot join

  • Severe heart failure defined as one or more of the below:
  • ACC/AHA/ESC Stage D heart failure, non-ambulatory NYHA Class IV HF
  • If BMI < 30, Cardiac index < 2.0 L/min/m2
  • If BMI ≥ 30, cardiac index < 1.8 L/min/m2
  • Inotropic infusion (continuous or intermittent) within the past 6 months
  • Patient is on the cardiac transplant waiting list
Show all 39Show fewer
  • LVEF < 20%
  • Presence of significant valve disease defined by the site cardiologist as:
  • Mitral valve regurgitation defined as grade > 3+ MR or > moderate MS
  • Tricuspid valve regurgitation defined as grade > 2+ TR
  • Aortic valve disease defined as > 2+ AR or > moderate AS
  • MI and/or any therapeutic invasive cardiac procedure within past 3 months; or current indication for coronary revascularization
  • Valve replacement or surgical annuloplasty within the past 12 months
  • Stroke or transient ischemic attack (TIA) within the past 6 months
  • Hemodynamic instability within 30 days of scheduled implant procedure
  • Patient requiring surgery under general anesthesia for any reason within 30 days of scheduled implant procedure
  • Clinically diagnosed hypertrophic obstructive cardiomyopathy, constrictive pericarditis or other infiltrative cardiomyopathy (eg, hemochromatosis, sarcoidosis) at the time of screening per central screening committee
  • Has renal insufficiency as determined by creatinine (S-Cr) level > 2.5 mg/dL or estimated-GFR < 25ml/min/1.73 m2 by CKD-Epi equation; or currently requiring dialysis
  • Significant hepatic impairment defined as 3× upper limit of normal of transaminases, total bilirubin, or alkaline phosphatase
  • Right ventricular dysfunction, defined by the site cardiologist as:
  • More than mild RV dysfunction as estimated by TTE; OR
  • TAPSE <1.4 cm; OR
  • RV size ≥ LV size as estimated by TTE; OR
  • Echocardiographic or clinical evidence of congestive hepatopathy;
  • Evidence of pulmonary hypertension with PVR >4 Wood units
  • Performance of the 6 minute walk test with a distance <50m OR >600m
  • Subject is contraindicated to receive either dual antiplatelet therapy or warfarin (analogue); or has a documented coagulopathy
  • Known hypersensitivity to anticoagulation therapy or contrast agent, which cannot be adequately medicated
  • Known hypersensitivity to Nickel and/or Tantalum
  • In the judgment of the investigator, life expectancy <12 months for noncardiovascular reasons
  • In the opinion of the investigator and Central Screening Committee, the subject is not an appropriate candidate for the study
  • Anatomy or implantable device that is not compatible with or could potentially interfere with the Edwards Transcatheter Atrial Shunt System as determined by the Investigator and Central Screening Committee
  • Active endocarditis or infection within 3 months of scheduled implant procedure
  • Currently participating (e.g., undergoing trial specific exams/treatment/procedures) in an investigational drug or device study. Note: trials requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational trials.
  • Patient is a current intravenous drug user
  • Positive serum pregnancy test in female subjects of child-bearing potential or nursing mothers or planning on becoming pregnant during the duration of the trial
  • Patient is under guardianship
  • Known pre-existing shunting, determined to be clinically significant by the investigator and Central Screening Committee
  • Patients with a CRT lead in the coronary sinus

About this study

The Exploratory Study of the Edwards Transcatheter Atrial Shunt System is a multi-center, prospective, exploratory study to evaluate initial clinical safety, device functionality, and effectiveness of the Edwards Transcatheter Atrial Shunt System.

Conditions
Heart Failure
Being tested
Atrial 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.

  • Atrial ShuntDevice

    Transcatheter treatment of symptomatic left heart failure patients

Study groups in NCT04965623
Study groupRoleWhat they receive
Edwards Transcatheter Atrial Shunt SystemExperimentalEdwards Transcatheter Atrial Shunt System
Receives: Device: Atrial Shunt

What is being measured

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

  1. Rate of Safety Events (MACCREE, Re-Intervention)

    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 (4)

  1. Rate of 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 of 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. Change in Qp/Qs

    Comparison vs baseline of Qp/Qs value at 3 and 6 months

    Measured: Baseline, 3 months, 6 months

  4. Change in PCWP

    Comparison vs baseline of PCWP under the same test conditions

    Measured: Baseline, 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 posted16 Jul 2021
  2. Study start22 Feb 2021
  3. Primary completion6 Dec 2023
  4. Study completion6 Dec 2023

Why it stopped: This study was not initiated due to Covid. Then, Edwards Lifesciences elected to withdraw this study due to the initiation of the ALT-FLOW II randomized trial in Germany.

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04965623
Sponsor's protocol ID
2018-14
Acronym
AlT-FloW
Status last verified
Jul 2024
First submitted
7 Jul 2021
Last updated
19 Sep 2024
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 Atrial Shunt in people with Heart Failure, run by Edwards Lifesciences.

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 39 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: withdrawn, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

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 Safety Events (MACCREE, Re-Intervention) (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 NCT04965623.

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 19 Sep 2024.

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