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Pulsta® Transcatheter Pulmonary Valve Korean Multicenter Study

Primary Purpose

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

Status
Active
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pulsta® Transcatheter Pulmonary Valve (TPV) Replacement
Sponsored by
Taewoong Medical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Heart Defect

Eligibility Criteria

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

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.

Sites / Locations

  • Seoul National University Hospital
  • Sejong General Hospital
  • Samsung Medical Center
  • Asan Medical Center
  • Severance Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pulsta® Transcatheter Pulmonary Valve

Arm Description

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

Outcomes

Primary Outcome Measures

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

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.
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
New York Heart Association (NYHA) functional classification
Stent fracture
Stent fracture will be assessed by the investigator through radiography (X-ray, Fluoroscopy).
Catheter reintervention on TPV
Reoperation
Procedural / Device related serious adverse events
Death (all cause / procedural / device-related)
Other adverse events
Pulmonary regurgitant fraction
Pulmonary regurgitant fraction will be measured by cardiac MRI.

Full Information

First Posted
April 7, 2017
Last Updated
August 14, 2023
Sponsor
Taewoong Medical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03110861
Brief Title
Pulsta® Transcatheter Pulmonary Valve Korean Multicenter Study
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 22, 2017 (Actual)
Primary Completion Date
November 6, 2019 (Actual)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taewoong Medical Co., Ltd.

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 effectiveness of the TPV in patients with pulmonary valve dysfunction.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Defect, Pulmonary Valve; Insufficiency, Congenital, Pulmonary Valve Stenosis

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Pulsta® Transcatheter Pulmonary Valve
Arm Type
Experimental
Arm Description
Pulsta® Transcatheter Pulmonary Valve (TaeWoong Medical Co., Ltd. Korea)
Intervention Type
Device
Intervention Name(s)
Pulsta® Transcatheter Pulmonary Valve (TPV) Replacement
Intervention Description
Pulsta® Transcatheter Pulmonary Valve Replacement
Primary Outcome Measure Information:
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 months
Title
Procedural / Device related serious adverse events at 6month
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Procedural success
Description
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.
Time Frame
5 days
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 years
Title
Severity of pulmonary regurgitation
Time Frame
5 years
Title
New York Heart Association (NYHA) functional classification
Time Frame
5 years
Title
Stent fracture
Description
Stent fracture will be assessed by the investigator through radiography (X-ray, Fluoroscopy).
Time Frame
5 years
Title
Catheter reintervention on TPV
Time Frame
5 years
Title
Reoperation
Time Frame
5 years
Title
Procedural / Device related serious adverse events
Time Frame
5 years
Title
Death (all cause / procedural / device-related)
Time Frame
5 years
Title
Other adverse events
Time Frame
5 years
Title
Pulmonary regurgitant fraction
Description
Pulmonary regurgitant fraction will be measured by cardiac MRI.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gi Beom Kim, phD. MD.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Haehak-ro Jongno-gu
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Sejong General Hospital
City
Bucheon
State/Province
Hohyun-ro, Sosa-gu
ZIP/Postal Code
14754
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Ilwon-ro, Gangnam-gu
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
State/Province
Olympic-ro, Songpa-gu
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
State/Province
Yonsei-ro, Seodaemun-gu
ZIP/Postal Code
03722
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Pulsta® Transcatheter Pulmonary Valve Korean Multicenter Study

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