Pulsta® Transcatheter Pulmonary Valve Korean Multicenter Study

Congenital Heart Defect Clinical Trial

Official title:

A Prospective, Multicenter, Single Arm Study to Evaluate the Safety and Effectiveness of Implantation of 'Transcatheter Pulmonary Valve (TPV)' for the Treatment of Congenital Heart Disease With Pulmonary Valve Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03110861
• Other study ID #: TPV-101
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 22, 2017
• Est. completion date: December 2024

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: December 2024
• Est. primary completion date: November 6, 2019
• 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 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.

Related Conditions & MeSH terms

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

Intervention

Device:
• Pulsta® Transcatheter Pulmonary Valve (TPV) Replacement
Pulsta® Transcatheter Pulmonary Valve Replacement

Locations

Country	Name	City	State
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	Samsung Medical Center	Seoul	Ilwon-ro, Gangnam-gu
Korea, Republic of	Seoul National University Hospital	Seoul	Haehak-ro Jongno-gu
Korea, Republic of	Severance Hospital	Seoul	Yonsei-ro, Seodaemun-gu

Sponsors (1)

Lead Sponsor	Collaborator
Taewoong Medical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Procedural / Device related serious adverse events at 6month		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.	5 days
Secondary	Hemodynamic function	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.	5 years
Secondary	Severity of pulmonary regurgitation		5 years
Secondary	New York Heart Association (NYHA) functional classification		5 years
Secondary	Stent fracture	Stent fracture will be assessed by the investigator through radiography (X-ray, Fluoroscopy).	5 years
Secondary	Catheter reintervention on TPV		5 years
Secondary	Reoperation		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
Secondary	Pulmonary regurgitant fraction	Pulmonary regurgitant fraction will be measured by cardiac MRI.	6 months