Clinical trial NCT02987387: COMPASSION XT PAS - Post-approval Study of the SAPIEN XT THV in Patients With Pulmonary Valve Dysfunction
Official title: New Enrollment SAPIEN XT Post-Approval Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pulmonary Valve Insufficiency
Pulmonary Valve Stenosis
Heart Defects, Congenital
Congenital Abnormalities
Cardiovascular Diseases
Heart Diseases
Keywords: Tetralogy of Fallot
Aortic Valve Defect/Disease Resulting in Ross Procedure
Transcatheter pulmonary valve implantation
Transcatheter pulmonary valve replacement
Pulmonary Atresia
Pulmonary Stenosis
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2016-12-08
Enrollment: 57
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric and adult patients with a dysfunctional, non-compliant right ventricular outflow tract (RVOT) conduit with a clinical indication for intervention.

Brief summary: This study will confirm the safety and effectiveness of the Edwards Lifesciences SAPIEN XT Transcatheter Heart Valve (THV) System in patients with a dysfunctional right ventricular outflow tract (RVOT) conduit with a clinical indication for intervention in a post-market setting.

Detailed description: The study is a prospective, non-randomized, multi-center clinical study to assess the safety and effectiveness of pulmonic implantation of the SAPIEN THV in patients with dysfunctional RVOT conduits requiring treatment for moderate or severe pulmonary regurgitation (PR) by transthoracic echocardiography (TTE) and/or RVOT conduit obstruction with a mean gradient of ≥ 35 mmHg by TTE.

Eligibility criteria: Inclusion Criteria:

1. Patient has a dysfunctional, non-compliant RVOT conduit.
2. The patient/patient's legally authorized representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion Criteria:

1. Inability to tolerate an anticoagulation/antiplatelet regimen
2. Active bacterial endocarditis

Primary outcomes:
measure: Freedom from device- or procedure-related death or reintervention
timeFrame: 1 year
Secondary outcomes:
measure: Decrease in pulmonary regurgitation to mild or less for regurgitant lesions
timeFrame: 1 year
measure: Decrease in RVOT mean gradient to less than 30 mmHg for stenotic lesions
timeFrame: 1 year
measure: Device Success
timeFrame: 48 Hours Prior to Discharge
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Oak Lawn
country: United States
facility: Advocate Children's Hospital
state: Illinois
city: Iowa City
country: United States
facility: The University of Iowa
state: Iowa
city: Detroit
country: United States
facility: Children's Hospital of Michigan
state: Michigan
city: Las Vegas
country: United States
facility: Children's Heart Center Nevada
state: Nevada
city: Newark
country: United States
facility: Newark Beth Israel Medical Center
state: New Jersey
city: New York
country: United States
facility: Mount Sinai Beth Israel
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh of UPMC
state: Pennsylvania
Study officials:
References: