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

Primary Purpose

Congenital Heart Defects, Cardiovascular Abnormalities, Pulmonary Valve Insufficiency

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Transcatheter Pulmonary Valve (TPV)
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Heart Defects focused on measuring Pulmonary Valve, Transcatheter Pulmonary Valve, Congenital Heart Disease

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transcatheter Pulmonary Valve

Arm Description

Transcatheter Pulmonary Valve (TaeWoong Medical Co., Ltd. Korea)

Outcomes

Primary Outcome Measures

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.
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).
Procedural / Device related serious adverse events at 6month

Secondary Outcome Measures

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

Full Information

First Posted
September 9, 2015
Last Updated
February 3, 2023
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02555319
Brief Title
A Feasibility Study to Evaluate the Safety and Short-term Effectiveness of Transcatheter Pulmonary Valve (TPV)
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
August 26, 2015 (Actual)
Primary Completion Date
April 14, 2017 (Actual)
Study Completion Date
October 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Defects, Cardiovascular Abnormalities, Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis
Keywords
Pulmonary Valve, Transcatheter Pulmonary Valve, Congenital Heart Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcatheter Pulmonary Valve
Arm Type
Experimental
Arm Description
Transcatheter Pulmonary Valve (TaeWoong Medical Co., Ltd. Korea)
Intervention Type
Device
Intervention Name(s)
Transcatheter Pulmonary Valve (TPV)
Intervention Description
Transcatheter Pulmonary Valve Replacement
Primary Outcome Measure Information:
Title
Procedural success
Description
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.
Time Frame
5day
Title
Hemodynamic functional improvement at 6month
Description
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).
Time Frame
6 month
Title
Procedural / Device related serious adverse events at 6month
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Hemodynamic function
Description
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.
Time Frame
5 year
Title
Severity of pulmonary regurgitation
Time Frame
5year
Title
Pulmonary regurgitant fraction
Time Frame
5year
Title
New York Heart Association (NYHA) functional classification
Time Frame
5 year
Title
Stent fracture
Time Frame
5 year
Title
Catheter reintervention on TPV
Time Frame
5 year
Title
Reoperation
Time Frame
5 year
Title
Procedural / Device related serious adverse events
Time Frame
5 year
Title
Death (all cause / procedural / device-related)
Time Frame
5 year
Title
Other adverse events
Time Frame
5 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gi Beom Kim, PhD. MD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Haehak-ro Jongno-gu
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29871940
Citation
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.
Results Reference
derived

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

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