A Feasibility Study to Evaluate the Safety and Short-term Effectiveness of Transcatheter Pulmonary Valve (TPV)

Congenital Heart Defects Clinical Trial

Official title:

A Feasibility Study to Evaluate the Safety and Short-term Effectiveness of Implantation of Transcatheter Pulmonary Valve (TPV) for the Treatment of Congenital Heart Disease With Pulmonary Valve Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02555319
• Other study ID #: TPV-001
• Status: Completed
• Phase: N/A
• Start date: August 26, 2015
• Est. completion date: October 25, 2021

Study information

• Verified date: January 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and short-term effectiveness of implantation of Transcatheter Pulmonary Valve (TPV) for the treatment of congenital heart disease with pulmonary valve disease.

Description:

Diverse congenital heart diseases involving the pulmonary artery, such as Tetralogy of Fallot (TOF) with or without pulmonary atresia, or transposition of the great arteries with pulmonary stenosis, require implantation of an artificial conduit between the right ventricle and the pulmonary artery(PA). Because these conduits finally degenerate and result in pulmonary regurgitation and/or stenosis and progressive right ventricle (RV) dilation and eventual failure, patients need repetitive surgery for conduit revision. Transcatheter pulmonary valve implantation (TPVI) is a less invasive alternative to surgery in patients with dysfunctional right ventricular outflow tract (RVOT). TPV is a large-diameter (up to 28 mm) self-expandable stent with a relatively low profile from a nitinol wire backbone with valve leaflets made from porcine pericardial tissue. 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 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: Completed
• Enrollment: 10
• Est. completion date: October 25, 2021
• Est. primary completion date: April 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

Inclusion Criteria:

• Age greater than or equal to 10 years of age
• 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 =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

• Cardiovascular Abnormalities
• Congenital Heart Defects
• Heart Defects, Congenital
• Pulmonary Valve Insufficiency
• Pulmonary Valve Stenosis

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul	Haehak-ro Jongno-gu

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedural success	Procedural success is defined as the TPV implant within desired position, 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.	5day
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 month
Primary	Procedural / Device related serious adverse events at 6month		6 month
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 year
Secondary	Severity of pulmonary regurgitation		5year
Secondary	Pulmonary regurgitant fraction		5year
Secondary	New York Heart Association (NYHA) functional classification		5 year
Secondary	Stent fracture		5 year
Secondary	Catheter reintervention on TPV		5 year
Secondary	Reoperation		5 year
Secondary	Procedural / Device related serious adverse events		5 year
Secondary	Death (all cause / procedural / device-related)		5 year
Secondary	Other adverse events		5 year