PULSTA Transcatheter Pulmonary Valve Pre-Approval Study

Not Applicable

Active, not recruiting

• Conditions: Pulmonary Valve Stenosis; Heart Diseases; Pulmonary Valve Regurgitation; Tetralogy of Fallot
• Interventions: Device: PULSTA TPV System

• Registration Number: NCT03983512
• Lead Sponsor: Taewoong Medical Co., Ltd.

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.

Detailed Description

The PULSTA TPV is a self-expandable valve with flared-ends to adapt to the larger native right ventricular outflow tract (RVOT) and is using a relatively low profile delivery catheter from knitted nitinol wire backbone and trileaflets made from treated porcine pericardial tissue, and a delivery system, which provides access to the right ventricular outflow tract through blood vessels. Consecutive subject data should be collected at discharge, 1, 6 months, and 1-5 years post PULSTA TPV implantation.

Study Timeline

• Study First Submitted: 2019-06-07
• Study First Submitted QC: 2019-06-10
• Study First Posted: 2019-06-12
• Study Start: 2019-10-07
• Primary Completion: 2022-09-21
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-13
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PULSTA TPV	PULSTA TPV System	PULSTA Transcatheter Pulmonary Valve (TPV) System

Primary Outcome Measures

Name	Time	Method
Procedural/Device related serious adverse events at 6 months	6 months
Hemodynamic functional improvement at 6 months	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)

Secondary Outcome Measures

Name	Time	Method
Other adverse events	5 years
Pulmonary Regurgitant Fraction	6months	Pulmonary regurgitant fraction (PRF) will be assessed via cardiac MRI at 6 months after the PULSTA TPV implantation.
Severity of Pulmonary Regurgitation	5 years	Severity of pulmonary regurgitation will be assessed via Doppler echocardiography.
NYHA functional classification	5 years	Clinical outcome will be assessed as per the New York Heart Association (NYHA) functional classification t all follow-up visits and will be compared to baseline values.
Reoperation	5 years	Reoperation is defined as open surgery that alters or adjusts, or replaces a previously implanted PULSTA TPV during a 5-year follow-up period, and the frequency will be evaluated.
Procedural Success	7 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 assessed including peak RVOT pressure gradient, mean RVOT pressure gradient, right ventricle (RV) end-diastolic volume index by echocardiography or cardiac MR.
Catheter reintervention on TPV	5 years	Catheter re-intervention on PULSTA TPV is defined as any interventional catheter procedure (e.g. balloon angioplasty) that alters or adjusts, or replaces a previously implanted PULSTA TPV during a 5-year follow-up period, and the frequency will be evaluated.
Procedural / Device related serious adverse events	5 years
Death (All cause / procedural/device-related)	5 years

Trial Locations

Locations (11)

Erasmus Medical Center; 🇳🇱 Rotterdam, Wytemaweg, Netherlands

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

Policlinico San Donato; 🇮🇹 Milan, San Donato Milanese, Italy

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

Deutsches Herzzentrum Munchen; 🇩🇪 München, Germany

Utrecht University Wilhelmina; 🇳🇱 Utrecht, Netherlands

Gregorio Marañon hospital; 🇪🇸 Madrid, Spain

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

Koc University Hospital; 🇹🇷 Istanbul, Topkapı, Zetinburnu/İstanbul, Turkey

Siyami Ersek Hospital; 🇹🇷 Istanbul, Üsküdar/İstanbul, Turkey

University Hospital La Paz; 🇪🇸 Madrid, Spain