Pulsta® Transcatheter Pulmonary Valve Korean Multicenter Study

Not Applicable

Completed

• Conditions: Pulmonary Valve; Insufficiency, Congenital; Congenital Heart Defect; Pulmonary Valve Stenosis
• Interventions: Device: Pulsta® Transcatheter Pulmonary Valve (TPV) Replacement

• Registration Number: NCT03110861
• Lead Sponsor: Taewoong Medical Co., Ltd.

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.

Study Timeline

• Study Start: 2017-03-22
• Study First Submitted: 2017-04-07
• Study First Submitted QC: 2017-04-07
• Study First Posted: 2017-04-12
• Primary Completion: 2019-11-06
• Study Completion: 2024-07-12
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-27
• Last Update Posted: 2024-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Hemodynamic functional improvement at 6month	6 months	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 months

Secondary Outcome Measures

Name	Time	Method
Procedural success	5 days	Procedural success is defined as the TPV implant within desired position, Right ventricle-Pulmonary artery (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 function	5 years	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	5 years
New York Heart Association (NYHA) functional classification	5 years
Catheter reintervention on TPV	5 years
Reoperation	5 years
Death (all cause / procedural / device-related)	5 years
Stent fracture	5 years	Stent fracture will be assessed by the investigator through radiography (X-ray, Fluoroscopy).
Other adverse events	5 years
Procedural / Device related serious adverse events	5 years
Pulmonary regurgitant fraction	6 months	Pulmonary regurgitant fraction will be measured by cardiac MRI.

Trial Locations

Locations (5)

Samsung Medical Center; 🇰🇷 Seoul, Ilwon-ro, Gangnam-gu, Korea, Republic of

Sejong General Hospital; 🇰🇷 Bucheon, Hohyun-ro, Sosa-gu, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Olympic-ro, Songpa-gu, Korea, Republic of

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

Severance Hospital; 🇰🇷 Seoul, Yonsei-ro, Seodaemun-gu, Korea, Republic of