PULSTA Transcatheter Pulmonary Valve Pre-Approval Study

Heart Diseases Clinical Trial

Official title:

The PULSTA Transcatheter Pulmonary Valve (TPV) Pre-Approval Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03983512
• Other study ID #: TWTPV-E1001
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 7, 2019
• Est. completion date: August 2026

Study information

• Verified date: March 2024
• Source: Taewoong Medical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 58
• Est. completion date: August 2026
• Est. primary completion date: July 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Diseases
• Pulmonary Valve Insufficiency
• Pulmonary Valve Regurgitation
• Pulmonary Valve Stenosis
• Tetralogy of Fallot

Intervention

Device:
• PULSTA TPV System
PULSTA transcatheter pulmonary valve replacement.

Locations

Country	Name	City	State
Germany	Deutsches Herzzentrum Munchen	München
Italy	Policlinico San Donato	Milan	San Donato Milanese
Korea, Republic of	Sejong General Hospital	Bucheon	Hohyun-ro, Sosa-gu
Korea, Republic of	Seoul National University Hospital	Seoul	Haehak-ro Jongno-gu
Korea, Republic of	Severance Hospital	Seoul	Yonsei-ro, Seodaemun-gu
Netherlands	Erasmus Medical Center	Rotterdam	Wytemaweg
Netherlands	Utrecht University Wilhelmina	Utrecht
Spain	Gregorio Marañon hospital	Madrid
Spain	University Hospital La Paz	Madrid
Turkey	Koc University Hospital	Istanbul	Topkapi, Zetinburnu/Istanbul
Turkey	Siyami Ersek Hospital	Istanbul	Üsküdar/Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Taewoong Medical Co., Ltd.	Avania

Countries where clinical trial is conducted

Germany,  Italy,  Korea, Republic of,  Netherlands,  Spain,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedural/Device related serious adverse events at 6 months		6 months
Primary	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	Procedural Success	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.	7 days
Secondary	Hemodynamic Function	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.	5 years
Secondary	Pulmonary Regurgitant Fraction	Pulmonary regurgitant fraction (PRF) will be assessed via cardiac MRI at 6 months after the PULSTA TPV implantation.	6months
Secondary	Severity of Pulmonary Regurgitation	Severity of pulmonary regurgitation will be assessed via Doppler echocardiography.	5 years
Secondary	NYHA functional classification	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.	5 years
Secondary	Catheter reintervention on TPV	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.	5 years
Secondary	Reoperation	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.	5 years
Secondary	Procedural / Device related serious adverse events		5 years
Secondary	Death (All cause / procedural/device-related)		5 years
Secondary	Other adverse events		5 years