ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent

Congenital Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03130777
• Other study ID #: 2016-04
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 22, 2017
• Est. completion date: June 2032

Study information

• Verified date: August 2023
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 86
• Est. completion date: June 2032
• Est. primary completion date: July 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases
• Pulmonary Disease
• Pulmonary Regurgitation
• Pulmonary Valve Insufficiency
• Tetralogy of Fallot
• Transcatheter Pulmonary Valve Replacement (TPVR)

Intervention

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.

Locations

Country	Name	City	State
United States	Emory University/ Children's Healthcare of Atlanta (CHOA)	Atlanta	Georgia
United States	Children's Hospital Colorado	Aurora	Colorado
United States	University of Virgina	Charlottesville	Virginia
United States	Cincinnati Children's Hospital	Cincinnati	Ohio
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	Children's Health Dallas	Dallas	Texas
United States	Texas Children's Hospital	Houston	Texas
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	University of California, Los Angeles	Los Angeles	California
United States	Columbia University Medical Center	New York	New York
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	St. Louis Children's Hospital	Saint Louis	Missouri
United States	University of California, San Francisco	San Francisco	California
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months
Primary	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	24 hours
Secondary	Main Cohort: Improvement in Total Pulmonary Regurgitation From Baseline	Number of patients with improvement in total pulmonary regurgitation	30 days