A Feasibility Study to Evaluate the Safety and Short-term Effectiveness of Transcatheter Pulmonary Valve (TPV)

Not Applicable

Completed

• Conditions: Pulmonary Valve Insufficiency; Congenital Heart Defects; Pulmonary Valve Stenosis; Cardiovascular Abnormalities
• Interventions: Device: Transcatheter Pulmonary Valve (TPV)

• Registration Number: NCT02555319
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study Start: 2015-08-26
• Study First Submitted: 2015-09-09
• Study First Submitted QC: 2015-09-17
• Study First Posted: 2015-09-21
• Primary Completion: 2017-04-14
• Study Completion: 2021-10-25
• Status Verified: 2023-01
• Last Update Submitted: 2023-02-03
• Last Update Posted: 2023-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transcatheter Pulmonary Valve	Transcatheter Pulmonary Valve (TPV)	Transcatheter Pulmonary Valve (TaeWoong Medical Co., Ltd. Korea)

Primary Outcome Measures

Name	Time	Method
Procedural success	5day	Procedural success is defined as the TPV implant within desired position, RV-PA peak systolic pressure gradient \<35mmHg by catheter, less mild pulmonary regurgitation by angiography, and freedom from explantation of the TPV at 24 hours post-implant.
Hemodynamic functional improvement at 6month	6 month	Hemodynamic functional improvement is defined as mean RVOT gradient ≤30 mmHg by continuous wave doppler, and a pulmonary regurgitant fraction \<20% by cardiac magnetic resonance (MR).
Procedural / Device related serious adverse events at 6month	6 month

Secondary Outcome Measures

Name	Time	Method
Death (all cause / procedural / device-related)	5 year
Other adverse events	5 year
Hemodynamic function	5 year	Hemodynamic function will be measured including peak RVOT pressure gradient, mean RVOT pressure gradient, RV-PA pressure gradient, RV pressure, cardiac output, cardiac index, RV end-diastolic volume by echocardiography, cardiac MR, or catheterization.
Severity of pulmonary regurgitation	5year
Pulmonary regurgitant fraction	5year
New York Heart Association (NYHA) functional classification	5 year
Stent fracture	5 year
Catheter reintervention on TPV	5 year
Reoperation	5 year
Procedural / Device related serious adverse events	5 year

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Haehak-ro Jongno-gu, Korea, Republic of