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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

Tracking Information
First Submitted Date  ICMJE June 24, 2019
First Posted Date  ICMJE June 27, 2019
Last Update Posted Date July 22, 2020
Actual Study Start Date  ICMJE January 1, 2019
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2020)
Composite of major adverse cardiac, cerebrovascular, renal events (MACCRE) and re-intervention for study device related complications at 30 days. [ Time Frame: 30 Days ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2020)
  • 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.
  • 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.
  • 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.
  • Performance/Effectiveness [ Time Frame: Baseline, 3 months, 6 months ]
    Comparison vs baseline of Qp/Qs value at 3 & 6 months
  • Performance/Effectiveness [ Time Frame: Baseline, 3 months, 6 months ]
    Improvement vs baseline of PCWP at 3 & 6 months
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exploratory Study of the Edwards Transcatheter Atrial Shunt System (ALt FLOW CANADA)
Official Title  ICMJE Exploratory Study of the Edwards Transcatheter Atrial Shunt System (ALt FLOW CANADA)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Heart Failure
Intervention  ICMJE Device: Atrial Shunt
Transcatheter treatment of symptomatic left heart failure patients
Study Arms  ICMJE Experimental: Edwards Transcatheter Atrial Shunt System
Intervention: Device: Atrial Shunt
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 24, 2020)
50
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE February 2023
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Melissa Arteaga 949-250-2002 Melissa_Arteaga@edwards.com
Contact: Ana Gonzalez 949-250-4419 Ana_L_Gonzalez@edwards.com
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04000607
Other Study ID Numbers  ICMJE 2018-11
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Edwards Lifesciences
Study Sponsor  ICMJE Edwards Lifesciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Edwards Lifesciences
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP