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ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent

Primary Purpose

Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR), Tetralogy of Fallot

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Edwards Alterra Adaptive Prestent with SAPIEN 3 THV
Sponsored by
Edwards Lifesciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cedars-Sinai Medical Center
  • University of California, Los Angeles
  • University of California, San Francisco
  • Children's Hospital Colorado
  • Emory University/ Children's Healthcare of Atlanta (CHOA)
  • St. Louis Children's Hospital
  • Columbia University Medical Center
  • Cincinnati Children's Hospital
  • Nationwide Children's Hospital
  • Children's Hospital of Philadelphia
  • Children's Health Dallas
  • Texas Children's Hospital
  • University of Virgina
  • Seattle Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

TPVR - Main Cohort

TPVR - PDS Registry

Arm Description

Implantation of Edwards Alterra Adaptive Prestent and Edwards SAPIEN 3 THV using Commander Delivery System.

Implantation of Edwards Alterra Adaptive Prestent and Edwards SAPIEN 3 THV using Pulmonic Delivery System (PDS).

Outcomes

Primary Outcome Measures

Main Cohort: THV Dysfunction
Number of patients with THV dysfunction, 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
PDS Registry: Acute PDS Success
Number of patients with acute PDS success, 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

Main Cohort: Improvement in Total Pulmonary Regurgitation From Baseline
Number of patients with improvement in total pulmonary regurgitation

Full Information

First Posted
April 24, 2017
Last Updated
August 7, 2023
Sponsor
Edwards Lifesciences
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1. Study Identification

Unique Protocol Identification Number
NCT03130777
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 22, 2017 (Actual)
Primary Completion Date
July 14, 2022 (Actual)
Study Completion Date
June 2032 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Edwards Lifesciences

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR), Tetralogy of Fallot, Congenital Heart Disease, Pulmonary Regurgitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single arm, prospective, multi-center study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TPVR - Main Cohort
Arm Type
Experimental
Arm Description
Implantation of Edwards Alterra Adaptive Prestent and Edwards SAPIEN 3 THV using Commander Delivery System.
Arm Title
TPVR - PDS Registry
Arm Type
Experimental
Arm Description
Implantation of Edwards Alterra Adaptive Prestent and Edwards SAPIEN 3 THV using Pulmonic Delivery System (PDS).
Intervention Type
Device
Intervention Name(s)
Edwards Alterra Adaptive Prestent with SAPIEN 3 THV
Intervention Description
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 Measure Information:
Title
Main Cohort: THV Dysfunction
Description
Number of patients with THV dysfunction, 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
Time Frame
6 months
Title
PDS Registry: Acute PDS Success
Description
Number of patients with acute PDS success, 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
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Main Cohort: Improvement in Total Pulmonary Regurgitation From Baseline
Description
Number of patients with improvement in total pulmonary regurgitation
Time Frame
30 days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Weight is ≥ 20 kg (44 lbs). RVOT/PV with moderate or greater PR by TTE. 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: Active infection requiring current antibiotic therapy (if temporary illness, patient may be a candidate 2 weeks after discontinuation of antibiotics). History of or active endocarditis (active treatment with antibiotics) within the past 180 days. Leukopenia (WBC < 2000 cells/μL), anemia (Hgb < 7 g/dL), thrombocytopenia (platelets < 50,000 cells/μL) or any known blood clotting disorder. Inappropriate anatomy for introduction and delivery of the Alterra Adaptive Prestent or the SAPIEN 3 THV. 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 Interventional/surgical procedures within 30 days prior to the Alterra or valve implant procedure Any planned surgical, percutaneous coronary or peripheral procedure to be performed within the 30 day follow-up from the Alterra or valve implant procedure History of or current intravenous drug use Major or progressive non-cardiac disease resulting in a life expectancy of less than one year Known hypersensitivity to aspirin or heparin and cannot be treated with other antiplatelet and/or antithrombotic medications Known hypersensitivity to nitinol, cobalt-chromium, nickel or contrast media that cannot be adequately pre-medicated 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.] Positive urine or serum pregnancy test in female patients of child-bearing potential Renal insufficiency (creatinine > 3.0 mg/dL) and/or renal replacement therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evan Zahn, MD, FACC, FSCAI
Organizational Affiliation
Cedars-Sinai Heart Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94122
Country
United States
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Emory University/ Children's Healthcare of Atlanta (CHOA)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
St. Louis Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Cincinnati Children's Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Children's Health Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Virgina
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent

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