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Exploratory Study of the Edwards Transcatheter Atrial Shunt System (ALt FLOW CANADA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04000607
Recruitment Status : Recruiting
First Posted : June 27, 2019
Last Update Posted : July 22, 2020
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Brief 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.

Condition or disease Intervention/treatment Phase
Heart Failure Device: Atrial Shunt Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exploratory Study of the Edwards Transcatheter Atrial Shunt System (ALt FLOW CANADA)
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Edwards Transcatheter Atrial Shunt System Device: Atrial Shunt
Transcatheter treatment of symptomatic left heart failure patients




Primary Outcome Measures :
  1. Composite of major adverse cardiac, cerebrovascular, renal events (MACCRE) and re-intervention for study device related complications at 30 days. [ Time Frame: 30 Days ]

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Clinical Success [ Time Frame: 30 Days ]
    Procedural success without major adverse cardiac, cerebrovascular, and renal events (MACCRE) or re-intervention for study device related complications at 30 days.

  4. Performance/Effectiveness [ Time Frame: Baseline, 3 months, 6 months ]
    Comparison vs baseline of Qp/Qs value at 3 & 6 months

  5. Performance/Effectiveness [ Time Frame: Baseline, 3 months, 6 months ]
    Improvement vs baseline of PCWP at 3 & 6 months



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed and dated approved informed consent form prior to study related procedures
  2. Eighteen years of age or older
  3. Chronic symptomatic Heart Failure (HF) documented by the following:

    1. NYHA class II with a history of NYHA class III or greater; 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
  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 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 3 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. Cardiac Resynchronization Therapy initiated, 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)
  9. Has renal insufficiency as determined by creatinine (S-Cr) level > 220 micrmol/L 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 >400m
  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
  17. In the judgment of the investigator, life expectancy <12 months for noncardiovascular reasons
  18. In the opinion of the investigator, the subject is not an appropriate candidate for the study
  19. Anatomy (including implantable devices) that is not compatible with the Edwards Transcatheter Atrial Shunt System
  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. History of intravenous drug use in the last 12 months
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04000607


Contacts
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Contact: Melissa Arteaga 949-250-2002 Melissa_Arteaga@edwards.com
Contact: Ana Gonzalez 949-250-4419 Ana_L_Gonzalez@edwards.com

Locations
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Canada, British Columbia
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Naomi Uchida    604-875-4521    naomi.uchida@ubc.ca   
Principal Investigator: Jacqueline Saw, MD         
Canada, Ontario
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada
Contact: Hannah Feagan    613-696-7000 ext 12678    hfeagan@ottawaheart.ca   
Principal Investigator: Benjamin Hibbert, MD         
Sponsors and Collaborators
Edwards Lifesciences
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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT04000607    
Other Study ID Numbers: 2018-11
First Posted: June 27, 2019    Key Record Dates
Last Update Posted: July 22, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases