This study is in progress, not accepting new patients

ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent

a study on Pulmonary Disease Transcatheter Pulmonary Valve Replacement Tetralogy of Fallot Congenital Heart Defects Pulmonary Regurgitation Heart Disease

Location: at San Francisco, California and other locations
Dates: study started August 2017
study ends around June 2032

Description

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.

Official Title

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

Keywords

Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR), Tetralogy of Fallot, Congenital Heart Disease, Pulmonary Regurgitation, Heart Diseases, Congenital Heart Defects, Pulmonary Valve Insufficiency, Edwards Alterra Adaptive Prestent with SAPIEN 3 THV, TPVR - PDS Registry

Eligibility

You can join if…

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.

You CAN'T join if...

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

Locations

UCSF
San Francisco California 94122 United States
Cedars-Sinai Medical Center
Los Angeles California 90048 United States

Details

Status: in progress, not accepting new patients
Start Date: August 2017
Completion Date: June 2032 (estimated)
Sponsor: Edwards Lifesciences
ID: NCT03130777
Study Type: Interventional
Participants: About 86 people participating
Last Updated: August 2024

ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent

Summary

Description

Summary

Official Title

Keywords

Eligibility

You can join if…

You CAN'T join if...

Locations

Details

Frequently Asked Questions