NCT02555319

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 26, 2015

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 21, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2017

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2021

Completed
Last Updated

February 6, 2023

Status Verified

January 1, 2023

Enrollment Period

1.6 years

First QC Date

September 9, 2015

Last Update Submit

February 3, 2023

Conditions

Congenital Heart DefectsCardiovascular AbnormalitiesPulmonary Valve InsufficiencyPulmonary Valve Stenosis

Keywords

Pulmonary ValveTranscatheter Pulmonary ValveCongenital Heart Disease

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (10)

  • Hemodynamic function

    5 year

  • Severity of pulmonary regurgitation

    5year

  • Pulmonary regurgitant fraction

    5year

  • New York Heart Association (NYHA) functional classification

    5 year

  • Stent fracture

    5 year

  • +5 more secondary outcomes

Study Arms (1)

Transcatheter Pulmonary Valve

EXPERIMENTAL

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

Device: Transcatheter Pulmonary Valve (TPV)

Interventions

Transcatheter Pulmonary Valve (TPV)DEVICE

Transcatheter Pulmonary Valve Replacement

Transcatheter Pulmonary Valve

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Haehak-ro Jongno-gu, 03080, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 29871940DERIVED

MeSH Terms

Conditions

Heart Defects, CongenitalCardiovascular AbnormalitiesPulmonary Valve InsufficiencyPulmonary Valve Stenosis

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHeart Valve DiseasesVentricular Outflow Obstruction

Study Officials

  • Gi Beom Kim, PhD. MD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2015

First Posted

September 21, 2015

Study Start

August 26, 2015

Primary Completion

April 14, 2017

Study Completion

October 25, 2021

Last Updated

February 6, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)