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ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent

Sponsor
Edwards Lifesciences (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03130777
Collaborator
(none)
85
Enrollment
13
Locations
2
Arms
111.3
Anticipated Duration (Months)
6.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Edwards Alterra Adaptive Prestent with SAPIEN 3 THV
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
85 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Single arm, prospective, multi-center studySingle 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 :
Aug 22, 2017
Actual Primary Completion Date :
Jul 14, 2022
Anticipated Study Completion Date :
Dec 1, 2026

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Main Cohort: THV Dysfunction [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 [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 [30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cedars-Sinai Medical Center Los Angeles California United States 90048
2 University of California, Los Angeles Los Angeles California United States 90095
3 University of California, San Francisco San Francisco California United States 94122
4 Children's Hospital Colorado Aurora Colorado United States 80045
5 Emory University/ Children's Healthcare of Atlanta (CHOA) Atlanta Georgia United States 30322
6 St. Louis Children's Hospital Saint Louis Missouri United States 63110
7 Columbia University Medical Center New York New York United States 10032
8 Nationwide Children's Hospital Columbus Ohio United States 43205
9 Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 19104
10 Children's Health Dallas Dallas Texas United States 75235
11 Texas Children's Hospital Houston Texas United States 77030
12 University of Virgina Charlottesville Virginia United States 22908
13 Seattle Children's Hospital Seattle Washington United States 98105

Sponsors and Collaborators

  • Edwards Lifesciences

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT03130777
Other Study ID Numbers:
  • 2016-04
First Posted:
Apr 26, 2017
Last Update Posted:
Aug 5, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Tetralogy of Fallot
Pulmonary Valve Insufficiency

Study Results

No Results Posted as of Aug 5, 2022