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

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Abnormalities; Pulmonary Valve Insufficiency; Pulmonary Valve Stenosis; Congenital Heart Defects
• Intervention / Treatment: Device: Transcatheter Pulmonary Valve (TPV)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Haehak-ro Jongno-gu
    • Seoul, Haehak-ro Jongno-gu, Korea, Republic of, 03080
      • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Transcatheter Pulmonary Valve; Transcatheter Pulmonary Valve (TaeWoong Medical Co., Ltd. Korea)	Device: Transcatheter Pulmonary Valve (TPV); Transcatheter Pulmonary Valve Replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Procedural / Device related serious adverse events at 6month		6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Severity of pulmonary regurgitation		5year
Pulmonary regurgitant fraction		5year
New York Heart Association (NYHA) functional classification		5 year
Stent fracture		5 year
Catheter reintervention on TPV		5 year
Reoperation		5 year
Procedural / Device related serious adverse events		5 year
Death (all cause / procedural / device-related)		5 year
Other adverse events		5 year

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Gi Beom Kim, PhD. MD, Seoul National University Hospital

Publications and helpful links

General Publications

• Kim GB, Song MK, Bae EJ, Park EA, Lee W, Lim HG, Kim YJ. Successful Feasibility Human Trial of a New Self-Expandable Percutaneous Pulmonary Valve (Pulsta Valve) Implantation Using Knitted Nitinol Wire Backbone and Trileaflet alpha-Gal-Free Porcine Pericardial Valve in the Native Right Ventricular Outflow Tract. Circ Cardiovasc Interv. 2018 Jun;11(6):e006494. doi: 10.1161/CIRCINTERVENTIONS.118.006494.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 26, 2015
• Primary Completion (ACTUAL): April 14, 2017
• Study Completion (ACTUAL): October 25, 2021

Study Registration Dates

• First Submitted: September 9, 2015
• First Submitted That Met QC Criteria: September 17, 2015
• First Posted (ESTIMATE): September 21, 2015

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2023
• Last Update Submitted That Met QC Criteria: February 3, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Congenital Heart Disease; Pulmonary Valve; Transcatheter Pulmonary Valve
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Valve Diseases; Ventricular Outflow Obstruction; Heart Defects, Congenital; Pulmonary Valve Insufficiency; Pulmonary Valve Stenosis; Cardiovascular Abnormalities
• Other Study ID Numbers: TPV-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No