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Early Feasibility Study - Transcatheter Atrial Shunt System (ALt FLOW US)

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ClinicalTrials.gov Identifier: NCT03523416
Recruitment Status : Recruiting
First Posted : May 14, 2018
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Brief Summary:
The purpose of this study is 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: Transcatheter Atrial Shunt System Not Applicable

Detailed Description:
The early feasibility study of the Edwards Transcatheter Atrial Shunt System is a multi-center, prospective, early feasibility study to evaluate initial clinical safety, device functionality, and effectiveness of the Edwards Transcatheter Atrial Shunt System.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: EArLy FeasibiLity Study Of the EdWards Transcatheter Atrial Shunt System (ALt FLOW US)
Actual Study Start Date : July 31, 2018
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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




Primary Outcome Measures :
  1. Composite of major adverse cardiac, cerebrovascular, or 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, or 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

  5. Performance/Effectiveness [ Time Frame: Baseline, 3 months, 6 months ]
    Improvement vs baseline of PCWP under the same test conditions (e.g. rest, legs raised, exercise)



Information from the National Library of Medicine

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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 IRB 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 II with a history of NYHA class > II; NYHA class III; or ambulatory NYHA class IV 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 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. 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 > 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
  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. 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

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): NCT03523416


Contacts
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Contact: Melissa Arteaga 949-250-2002 melissa_arteaga@edwards.com

Locations
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United States, California
UC San Diego Health Recruiting
La Jolla, California, United States, 92037
Contact: Alma V Fregoso    858-246-2507    avfregos@ucsd.edu   
Contact: Laura Linares    858-246-2413    lrlinares@health.ucsd.edu   
Principal Investigator: Ehtisham Mahmud, MD         
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Khaled Alsabaawi    310-423-6226    Khaled.Alsabaawi@cshs.org   
Contact: Mitch Gheorghiu    310 423-6152    Mitch.Gheorghiu@cshs.org   
Principal Investigator: Rajendra Makkar, MD         
United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Rachael L Burnett, MPH    303-724-2095    rachael.2.burnett@cuanschutz.edu   
Contact: Kylie Boynton       KYLIE.BOYNTON@cuanschutz.edu   
Principal Investigator: Andreas Brieke, MD         
United States, Florida
University of Florida Health - Jacksonville Recruiting
Jacksonville, Florida, United States, 32209
Contact: Azra Islamovic    904-244-5659    Azra.Islamovic@jax.ufl.edu   
Contact: Marijana Lukovic    904-244-2962    marijana.lukovic@jax.ufl.edu   
Principal Investigator: Emil Missov, MD         
Principal Investigator: Andres Pineda, MD         
United States, Indiana
St. Vincent Medical Group Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Regina Margiotti    317-338-9129    Regina.Margiotti@Ascension.org   
Contact: Anne Renick    317-338-6152    Anne.Renick@ascension.org   
Principal Investigator: Sunit-Preet Chaudhry, MD         
Principal Investigator: James Hermiller, MD         
United States, Minnesota
Abbott Northwestern Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Karen Meyer, RN    612-863-5855    Karen.meyer2@allina.com   
Contact: Jake Jensen    612-863-3818    Jacob.Jensen@allina.com   
Principal Investigator: Paul Sorajja, MD         
United States, North Carolina
Atrium Health Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Dana B Amaro    704-355-4692    Dana.Amaro@atriumhealth.org   
Contact: Connie Dellinger    704-355-4794    Connie.Dellinger@atriumhealth.org   
Principal Investigator: Jonathan Schwartz, MD         
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Zoe Kilmer    503-494-3491    kilmer@ohsu.edu   
Contact: Katie McCullough    503-494-6072    mccullka@ohsu.edu   
Principal Investigator: Firas Zahr, MD         
United States, Pennsylvania
Lankenau Institute for Medical Research Recruiting
Wynnewood, Pennsylvania, United States, 19096
Contact: Lisa Thome, MS    484-476-8570    ThomeL@MLHS.ORG   
Contact: Mary Welch       WelchM@MLHS.ORG   
Principal Investigator: William A Gray, MD         
Sponsors and Collaborators
Edwards Lifesciences
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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT03523416    
Other Study ID Numbers: 2018-02
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 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
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases