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ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent

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ClinicalTrials.gov Identifier: NCT03130777
Recruitment Status : Active, not recruiting
First Posted : April 26, 2017
Last Update Posted : April 19, 2021
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Brief Summary:

To demonstrate the safety and effectiveness of the Edwards Alterra Adaptive Prestent in conjunction with the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract/pulmonary valve (RVOT/PV) who are indicated for treatment of pulmonary regurgitation (PR).

Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.


Condition or disease Intervention/treatment Phase
Pulmonary Disease Transcatheter Pulmonary Valve Replacement (TPVR) Tetralogy of Fallot Congenital Heart Disease Pulmonary Regurgitation Device: Edwards Alterra Adaptive Prestent with SAPIEN 3 THV Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 85 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Single arm, prospective, multi-center study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Study of Congenital Pulmonic Valve Dysfunction Studying the SAPIEN 3 THV With the Alterra Adaptive Prestent
Actual Study Start Date : August 22, 2017
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : October 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TPVR - Main Cohort
Implantation of Edwards Alterra Adaptive Prestent and Edwards SAPIEN 3 THV using Commander Delivery System.
Device: Edwards Alterra Adaptive Prestent with SAPIEN 3 THV
The Edwards Alterra Adaptive Prestent is designed to reduce the diameter of large irregular RVOTs and provide a circular, semi-rigid landing zone to place an Edwards SAPIEN 3 THV.

Experimental: TPVR - PDS Registry
Implantation of Edwards Alterra Adaptive Prestent and Edwards SAPIEN 3 THV using Pulmonic Delivery System (PDS).
Device: Edwards Alterra Adaptive Prestent with SAPIEN 3 THV
The Edwards Alterra Adaptive Prestent is designed to reduce the diameter of large irregular RVOTs and provide a circular, semi-rigid landing zone to place an Edwards SAPIEN 3 THV.




Primary Outcome Measures :
  1. Main Cohort: THV Dysfunction [ Time Frame: 6 months ]

    Defined as a non-hierarchical composite of:

    • RVOT/PV Reintervention
    • Moderate or greater total Pulmonic Regurgitation via Transthoracic Echocardiography (TTE)
    • Mean RVOT/PV Gradient >= 35mmHg via TTE

  2. PDS Registry: Acute PDS Success [ Time Frame: 24 hours ]

    Defined as a non-hierarchical composite of:

    • Single THV implanted in the desired location
    • Right ventricle to pulmonary artery (RV-PA) peak-to-peak gradient < 35 mmHg post-THV implantation
    • Less than moderate total pulmonary regurgitation by discharge TTE (or earliest evaluable TTE)
    • Free of SAPIEN 3 / Alterra explant at 24 hours post-implantation


Secondary Outcome Measures :
  1. Main Cohort: Improvement in Total Pulmonary Regurgitation from Baseline [ Time Frame: 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The candidate/candidate's legally authorized representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
  2. Weight is ≥ 20 kg (44 lbs).
  3. RVOT/PV with moderate or greater PR by TTE.
  4. RVOT/PV proximal and distal landing zone diameter ≥ 27 mm and ≤ 38 mm, and minimum of 35 mm from contractile tissue to lowest pulmonary artery takeoff.

Exclusion Criteria:

  1. Active infection requiring current antibiotic therapy (if temporary illness, patient may be a candidate 2 weeks after discontinuation of antibiotics).
  2. History of or active endocarditis (active treatment with antibiotics) within the past 180 days.
  3. Leukopenia (WBC < 2000 cells/μL), anemia (Hgb < 7 g/dL), thrombocytopenia (platelets < 50,000 cells/μL) or any known blood clotting disorder.
  4. Inappropriate anatomy for introduction and delivery of the Alterra Adaptive Prestent or the SAPIEN 3 THV.
  5. Need for concomitant atrial septal defect or ventricular septal defect closure or other concomitant interventional procedures other than pulmonary artery or branch pulmonary artery stenting or angioplasty
  6. Interventional/surgical procedures within 30 days prior to the Alterra or valve implant procedure
  7. Any planned surgical, percutaneous coronary or peripheral procedure to be performed within the 30 day follow-up from the Alterra or valve implant procedure
  8. History of or current intravenous drug use
  9. Major or progressive non-cardiac disease resulting in a life expectancy of less than one year
  10. Known hypersensitivity to aspirin or heparin and cannot be treated with other antiplatelet and/or antithrombotic medications
  11. Known hypersensitivity to nitinol, cobalt-chromium, nickel or contrast media that cannot be adequately pre-medicated
  12. Currently participating in an investigational drug or another device study [Note: Trials requiring extended follow up for products that were investigational, but have since become commercially available, are not considered investigational devices.]
  13. Positive urine or serum pregnancy test in female patients of child-bearing potential
  14. Renal insufficiency (creatinine > 3.0 mg/dL) and/or renal replacement therapy

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): NCT03130777


Locations
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United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
University of California, Los Angeles
Los Angeles, California, United States, 90095
University of California, San Francisco
San Francisco, California, United States, 94122
United States, Colorado
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
United States, Georgia
Emory University/ Children's Healthcare of Atlanta (CHOA)
Atlanta, Georgia, United States, 30322
United States, Missouri
St. Louis Children's Hospital
Saint Louis, Missouri, United States, 63110
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Children's Health Dallas
Dallas, Texas, United States, 75235
Texas Children's Hospital
Houston, Texas, United States, 77030
United States, Virginia
University of Virgina
Charlottesville, Virginia, United States, 22908
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Edwards Lifesciences
Investigators
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Principal Investigator: Evan Zahn, MD, FACC, FSCAI Cedars-Sinai Heart Institute
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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT03130777    
Other Study ID Numbers: 2016-04
First Posted: April 26, 2017    Key Record Dates
Last Update Posted: April 19, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Respiratory Insufficiency
Heart Diseases
Tetralogy of Fallot
Pulmonary Valve Insufficiency
Respiratory Tract Diseases
Cardiovascular Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities
Heart Valve Diseases
Respiration Disorders