Pulsta® Transcatheter Pulmonary Valve Korean Multicenter Study

NCT03110861 | Completed DMC

• 1 other identifier: TPV-101
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Congenital Heart Defect; Pulmonary Valve; Insufficiency, Congenital; Pulmonary Valve Stenosis

Outcome Measures

Primary Outcomes (2)

• Hemodynamic functional improvement at 6month

  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).

  6 months

• Procedural / Device related serious adverse events at 6month

  6 months

Secondary Outcomes (11)

• Procedural success

  5 days

• Hemodynamic function

  5 years

• Severity of pulmonary regurgitation

  5 years

• New York Heart Association (NYHA) functional classification

  5 years

• Stent fracture

  5 years

Study Arms (1)

Pulsta® Transcatheter Pulmonary Valve

EXPERIMENTAL

Pulsta® Transcatheter Pulmonary Valve (TaeWoong Medical Co., Ltd. Korea)

Device: Pulsta® Transcatheter Pulmonary Valve (TPV) Replacement

Interventions

Pulsta® Transcatheter Pulmonary Valve (TPV) Replacement DEVICE

Pulsta® Transcatheter Pulmonary Valve Replacement

Pulsta® Transcatheter Pulmonary Valve

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taewoong Medical Co., Ltd.: lead

Study Sites (5)

Seoul National University Hospital

Seoul, Haehak-ro Jongno-gu, 03080, South Korea

Location

Sejong General Hospital

Bucheon-si, Hohyun-ro, Sosa-gu, 14754, South Korea

Location

Samsung Medical Center

Seoul, Ilwon-ro, Gangnam-gu, 06351, South Korea

Location

Asan Medical Center

Seoul, Olympic-ro, Songpa-gu, 05505, South Korea

Location

Severance Hospital

Seoul, Yonsei-ro, Seodaemun-gu, 03722, South Korea

Location

MeSH Terms

Conditions

Heart Defects, Congenital; Pulmonary Valve Stenosis

Interventions

Replantation

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Valve Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Officials

• Gi Beom Kim, phD. MD.

  Seoul National University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2017
• First Posted: April 12, 2017
• Study Start: March 22, 2017
• Primary Completion: November 6, 2019
• Study Completion: July 12, 2024
• Last Updated: September 4, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (5)