PULSTA Transcatheter Pulmonary Valve Pre-Approval Study

NCT03983512 | Active Not Recruiting DMC

• 1 other identifier: TWTPV-E1001
• Study Type: interventional
• Target: 58
• Locations: 6 countries
• Sites: 11

Brief Summary

The purpose of the study is to evaluate the safety and effectiveness of the PULSTA Transcatheter Pulmonary Valve (TPV) System for the treatment of congenital or acquired pulmonary valve stenosis and/or regurgitation who require pulmonary valve replacement.

Conditions

Tetralogy of Fallot; Heart Diseases; Pulmonary Valve Regurgitation; Pulmonary Valve Stenosis

Outcome Measures

Primary Outcomes (2)

• Procedural/Device related serious adverse events at 6 months

  6 months

• Hemodynamic functional improvement at 6 months

  Hemodynamic functional improvement is a composite of mean RVOT gradient ≤30 mmHg by continuous wave Doppler and a pulmonary regurgitant fraction \<20% by cardiac magnetic resonance (MR)

  6 months

Secondary Outcomes (10)

• Procedural Success

  7 days

• Hemodynamic Function

  5 years

• Pulmonary Regurgitant Fraction

  6months

• Severity of Pulmonary Regurgitation

  5 years

• NYHA functional classification

  5 years

Study Arms (1)

PULSTA TPV

EXPERIMENTAL

PULSTA Transcatheter Pulmonary Valve (TPV) System

Device: PULSTA TPV System

Interventions

PULSTA TPV System DEVICE

PULSTA transcatheter pulmonary valve replacement.

PULSTA TPV

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 or severe pulmonary regurgitation or pulmonary valve stenosis with mean gradient \>35mmHg by echocardiography
• Main pulmonary artery trunk of ≥16 mm and ≤30 mm
• Patients willing to provide written informed consent and comply with follow-up evaluations.

You may not qualify if:

• Females of child-bearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding an infant up until 6 months after TPV implantation
• Pre-existing mechanical valve in pulmonary position or require concomitant repair of other cardiac valves
• Obstruction of the central veins to be approached for the TPV implantation
• Coronary artery compression confirmed by angiography
• A known severe allergy to Nickel
• A known hypersensitivity to any anticoagulation therapy, contrast agent or a hemorrhagic disease
• Suspected active infectious disease (e.g. endocarditis, meningitis)
• Life expectancy of less than 6 months

Sponsors & Collaborators

• Taewoong Medical Co., Ltd.: lead
• Avania: collaborator

Study Sites (11)

Deutsches Herzzentrum Munchen

München, München, 80636, Germany

Location

Policlinico San Donato

Milan, San Donato Milanese, 20097, Italy

Location

Utrecht University Wilhelmina

Utrecht, Utrecht, 3508, Netherlands

Location

Erasmus Medical Center

Rotterdam, Wytemaweg, 3015, Netherlands

Location

Seoul National University Hospital

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

Location

Sejong General Hospital

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

Location

Severance Hospital

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

Location

Gregorio Marañon hospital

Madrid, Madrid, 28007, Spain

Location

University Hospital La Paz

Madrid, Madrid, 28046, Spain

Location

Koc University Hospital

Istanbul, Topkapı, Zetinburnu/İstanbul, 34010, Turkey (Türkiye)

Location

Siyami Ersek Hospital

Istanbul, Üsküdar/İstanbul, 34668, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Heart Diseases; Pulmonary Valve Insufficiency; Pulmonary Valve Stenosis; Tetralogy of Fallot

Condition Hierarchy (Ancestors)

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

Study Officials

• Mario Carminati, PhD. MD.

  Policlinico San Donato

  STUDY CHAIR

• Stanimir Georgiev, PhD. MD.

  Deutsches Herzzentrum Munchen

  PRINCIPAL INVESTIGATOR

• Jose Luis Zunzunegui, PhD. MD.

  Gregorio Marañon hospital

  PRINCIPAL INVESTIGATOR

• Federico Gutierrez Larraya, PhD. MD.

  Hospital Universitario La Paz

  PRINCIPAL INVESTIGATOR

• Ender Odemis, PhD. MD.

  Koc University Hospital

  PRINCIPAL INVESTIGATOR

• Ahmet Çelebi, PhD. MD.

  Siyami Ersek Hospital

  PRINCIPAL INVESTIGATOR

• Gregor Krings, PhD. MD.

  Utrecht University Wilhelmina

  PRINCIPAL INVESTIGATOR

• Thomas Krasemann, PhD. MD.

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

• Gi Beom Kim, PhD. MD.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

• Jae Young Choi, PhD. MD.

  Severance Hospital

  PRINCIPAL INVESTIGATOR

• Seong Ho Kim, PhD. MD.

  Sejong General Hospital

  PRINCIPAL INVESTIGATOR

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: June 7, 2019
• First Posted: June 12, 2019
• Study Start: October 7, 2019
• Primary Completion: September 21, 2022
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); IT (1); NL (2); KR (3); ES (2); TU (2)