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

September 11, 2024 updated by: Edwards Lifesciences
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Signed and dated Ethics Committee (EC) approved study consent form prior to study related procedures
  2. ≥ 18 years old

  3. Chronic symptomatic Heart Failure (HF) documented by the following:

    1. NYHA class III or ambulatory NYHA class IV within last 12 months AND
    2. ≥ 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.
  4. 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
  5. 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
  6. Willing to attend study follow-up assessments for up to 5 years

Exclusion Criteria:

  1. Severe heart failure defined as one or more of the below:

    1. ACC/AHA/ESC Stage D heart failure, non-ambulatory NYHA Class IV HF
    2. If BMI < 30, Cardiac index < 2.0 L/min/m2
    3. If BMI ≥ 30, cardiac index < 1.8 L/min/m2
    4. Inotropic infusion (continuous or intermittent) within the past 6 months
    5. Patient is on the cardiac transplant waiting list
    6. LVEF < 20%

  2. Presence of significant valve disease defined by the site cardiologist as:

    1. Mitral valve regurgitation defined as grade > 3+ MR or > moderate MS
    2. Tricuspid valve regurgitation defined as grade > 2+ TR
    3. Aortic valve disease defined as > 2+ AR or > moderate AS
  3. MI and/or any therapeutic invasive cardiac procedure within past 3 months; or current indication for coronary revascularization
  4. Valve replacement or surgical annuloplasty within the past 12 months
  5. Stroke or transient ischemic attack (TIA) within the past 6 months
  6. Hemodynamic instability within 30 days of scheduled implant procedure
  7. Patient requiring surgery under general anesthesia for any reason within 30 days of scheduled implant procedure
  8. Clinically diagnosed hypertrophic obstructive cardiomyopathy, constrictive pericarditis or other infiltrative cardiomyopathy (eg, hemochromatosis, sarcoidosis) at the time of screening per central screening committee
  9. 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
  10. Significant hepatic impairment defined as 3× upper limit of normal of transaminases, total bilirubin, or alkaline phosphatase

  11. Right ventricular dysfunction, defined by the site cardiologist as:

    1. More than mild RV dysfunction as estimated by TTE; OR
    2. TAPSE <1.4 cm; OR
    3. RV size ≥ LV size as estimated by TTE; OR
    4. Echocardiographic or clinical evidence of congestive hepatopathy;
  12. Evidence of pulmonary hypertension with PVR >4 Wood units
  13. Performance of the 6 minute walk test with a distance <50m OR >600m
  14. Subject is contraindicated to receive either dual antiplatelet therapy or warfarin (analogue); or has a documented coagulopathy
  15. Known hypersensitivity to anticoagulation therapy or contrast agent, which cannot be adequately medicated
  16. Known hypersensitivity to Nickel and/or Tantalum
  17. In the judgment of the investigator, life expectancy <12 months for noncardiovascular reasons
  18. In the opinion of the investigator and Central Screening Committee, the subject is not an appropriate candidate for the study
  19. 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
  20. Active endocarditis or infection within 3 months of scheduled implant procedure
  21. 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.
  22. Patient is a current intravenous drug user
  23. 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
  24. Patient is under guardianship
  25. Known pre-existing shunting, determined to be clinically significant by the investigator and Central Screening Committee
  26. Patients with a CRT lead in the coronary sinus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Edwards Transcatheter Atrial Shunt System
Device: Atrial Shunt
Transcatheter treatment of symptomatic left heart failure patients

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of Safety Events (MACCREE, Re-Intervention)
Time Frame: 30 Days
Composite of major adverse cardiac, cerebrovascular, renal events (MACCRE) and re-intervention for study device related complications at 30 days.
30 Days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of Device Success
Time Frame: Day 0
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.
Day 0
Rate of Procedural Success
Time Frame: 10 Days post-op
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.
10 Days post-op
Change in Qp/Qs
Time Frame: Baseline, 3 months, 6 months
Comparison vs baseline of Qp/Qs value at 3 and 6 months
Baseline, 3 months, 6 months
Change in PCWP
Time Frame: Baseline, 3 months, 6 months
Comparison vs baseline of PCWP under the same test conditions
Baseline, 3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Edwards Lifesciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 22, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 6, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 6, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 7, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018-14

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings