Clinical trial NCT03130777: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pulmonary Disease
Transcatheter Pulmonary Valve Replacement (TPVR)
Tetralogy of Fallot
Congenital Heart Disease
Pulmonary Regurgitation
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2017-04-26
Enrollment: 86
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Single arm, prospective, multi-center study
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Main Cohort: THV Dysfunction
timeFrame: 6 months
measure: PDS Registry: Acute PDS Success
timeFrame: 24 hours
Secondary outcomes:
measure: Main Cohort: Improvement in Total Pulmonary Regurgitation From Baseline
timeFrame: 30 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Atlanta
country: United States
facility: Emory University/ Children's Healthcare of Atlanta (CHOA)
state: Georgia
city: Saint Louis
country: United States
facility: St. Louis Children's Hospital
state: Missouri
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Dallas
country: United States
facility: Children's Health Dallas
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Charlottesville
country: United States
facility: University of Virgina
state: Virginia
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Cedars-Sinai Heart Institute
name: Evan Zahn, MD, FACC, FSCAI
role: PRINCIPAL_INVESTIGATOR
References: