Clinical trial NCT03110861: Pulsta® Transcatheter Pulmonary Valve Korean Multicenter Study
Official title: A Prospective, Multicenter, Single Arm Study to Evaluate the Safety and Effectiveness of Implantation of 'Transcatheter Pulmonary Valve (TPV)' for the Treatment of Congenital Heart Disease with Pulmonary Valve Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Defect
Pulmonary Valve; Insufficiency, Congenital
Pulmonary Valve Stenosis
Lead sponsor: Taewoong Medical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-04-12
Enrollment: 15
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of the TPV in patients with pulmonary valve dysfunction.

Detailed description: The TPV is indicated for use in patients with previous undergone replacement of bioprosthetic valve or conduit due to either pulmonary valve atresia, stenosis, regurgitation or a combination of them and present with dysfunctional right ventricular ourflow tract (RVOT) requiring treatment for severe pulmonary regurgitation and/or RVOT conduit obstruction. Consecutive subject data should be collected at discharge, 1, 3, 6 month, and 1-5 years post TPV implantation.

Eligibility criteria: Inclusion Criteria:

* Body weight greater than or equal to 30 kilograms
* Pulmonary regurgitation ≥moderate pulmonary regurgitation (PR) (≥3+) or RVOT conduit obstruction with mean gradient \>35mmHg by echocardiography
* pulmonary artery annulus or in situ conduit size of ≥16 and ≤26mm
* Patient willing to provide written informed consent and comply with follow-up requirements

Exclusion Criteria:

* Pre-existing mechanical heart valve in any position
* Obstruction of the central veins (pulmonic bioprosthesis delivery system to the heart)
* Coronary artery compression
* A known hypersensitivity to Aspirin or Heparin
* Immunosuppressive disease
* Active infectious disease (e.g. endocarditis, meningitis)
* Estimated survival less than 6 months
* Female of child-bearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding an infant.

Primary outcomes:
measure: Hemodynamic functional improvement at 6month
timeFrame: 6 months
measure: Procedural / Device related serious adverse events at 6month
timeFrame: 6 months
Secondary outcomes:
measure: Procedural success
timeFrame: 5 days
measure: Hemodynamic function
timeFrame: 5 years
measure: Severity of pulmonary regurgitation
timeFrame: 5 years
measure: New York Heart Association (NYHA) functional classification
timeFrame: 5 years
measure: Stent fracture
timeFrame: 5 years
measure: Catheter reintervention on TPV
timeFrame: 5 years
measure: Reoperation
timeFrame: 5 years
measure: Procedural / Device related serious adverse events
timeFrame: 5 years
measure: Death (all cause / procedural / device-related)
timeFrame: 5 years
measure: Other adverse events
timeFrame: 5 years
measure: Pulmonary regurgitant fraction
timeFrame: 6 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Haehak-ro Jongno-gu
city: Bucheon
country: Korea, Republic of
facility: Sejong General Hospital
state: Hohyun-ro, Sosa-gu
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Ilwon-ro, Gangnam-gu
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Olympic-ro, Songpa-gu
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
state: Yonsei-ro, Seodaemun-gu
Study officials:
affiliation: Seoul National University Hospital
name: Gi Beom Kim, phD. MD.
role: STUDY_CHAIR
References: