Clinical trial NCT02555319: A Feasibility Study to Evaluate the Safety and Short-term Effectiveness of Transcatheter Pulmonary Valve (TPV)
Official title: A Feasibility Study to Evaluate the Safety and Short-term 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 Defects
Cardiovascular Abnormalities
Pulmonary Valve Insufficiency
Pulmonary Valve Stenosis
Keywords: Pulmonary Valve
Transcatheter Pulmonary Valve
Congenital Heart Disease
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2015-09-21
Enrollment: 10
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 short-term effectiveness of implantation of Transcatheter Pulmonary Valve (TPV) for the treatment of congenital heart disease with pulmonary valve disease.

Detailed description: Diverse congenital heart diseases involving the pulmonary artery, such as Tetralogy of Fallot (TOF) with or without pulmonary atresia, or transposition of the great arteries with pulmonary stenosis, require implantation of an artificial conduit between the right ventricle and the pulmonary artery(PA). Because these conduits finally degenerate and result in pulmonary regurgitation and/or stenosis and progressive right ventricle (RV) dilation and eventual failure, patients need repetitive surgery for conduit revision. Transcatheter pulmonary valve implantation (TPVI) is a less invasive alternative to surgery in patients with dysfunctional right ventricular outflow tract (RVOT). TPV is a large-diameter (up to 28 mm) self-expandable stent with a relatively low profile from a nitinol wire backbone with valve leaflets made from porcine pericardial tissue. 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 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:

* Age greater than or equal to 10 years of age
* 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 ≥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: Procedural success
timeFrame: 5day
measure: Hemodynamic functional improvement at 6month
timeFrame: 6 month
measure: Procedural / Device related serious adverse events at 6month
timeFrame: 6 month
Secondary outcomes:
measure: Hemodynamic function
timeFrame: 5 year
measure: Severity of pulmonary regurgitation
timeFrame: 5year
measure: Pulmonary regurgitant fraction
timeFrame: 5year
measure: New York Heart Association (NYHA) functional classification
timeFrame: 5 year
measure: Stent fracture
timeFrame: 5 year
measure: Catheter reintervention on TPV
timeFrame: 5 year
measure: Reoperation
timeFrame: 5 year
measure: Procedural / Device related serious adverse events
timeFrame: 5 year
measure: Death (all cause / procedural / device-related)
timeFrame: 5 year
measure: Other adverse events
timeFrame: 5 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Haehak-ro Jongno-gu
Study officials:
affiliation: Seoul National University Hospital
name: Gi Beom Kim, PhD. MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim GB, Song MK, Bae EJ, Park EA, Lee W, Lim HG, Kim YJ. Successful Feasibility Human Trial of a New Self-Expandable Percutaneous Pulmonary Valve (Pulsta Valve) Implantation Using Knitted Nitinol Wire Backbone and Trileaflet alpha-Gal-Free Porcine Pericardial Valve in the Native Right Ventricular Outflow Tract. Circ Cardiovasc Interv. 2018 Jun;11(6):e006494. doi: 10.1161/CIRCINTERVENTIONS.118.006494.