Multicenter Study of Congenital Pulmonic Valve Dysfunction Studying the SAPIEN 3 THV With the Alterra Adaptive Prestent

Brief Title

ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent

Official Title

Multicenter Study of Congenital Pulmonic Valve Dysfunction Studying the SAPIEN 3 THV With the Alterra Adaptive Prestent

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.
    



Study Type

Interventional


Primary Outcome

Main Cohort: THV Dysfunction

Secondary Outcome

 Main Cohort: Improvement in Total Pulmonary Regurgitation from Baseline

Condition

Pulmonary Disease

Intervention

Edwards Alterra Adaptive Prestent with SAPIEN 3 THV

Study Arms / Comparison Groups

 TPVR - Main Cohort
Description:  Implantation of Edwards Alterra Adaptive Prestent and Edwards SAPIEN 3 THV using Commander Delivery System.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

85

Start Date

August 22, 2017

Completion Date

October 2026

Primary Completion Date

September 2021

Eligibility 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
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Evan Zahn, MD, FACC, FSCAI, (949) 250-2500, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03130777

Organization ID

2016-04


Responsible Party

Sponsor

Study Sponsor

Edwards Lifesciences


Study Sponsor

Evan Zahn, MD, FACC, FSCAI, Principal Investigator, Cedars-Sinai Heart Institute


Verification Date

June 2021