Clinical Trial: PULSTA® Transcatheter Pulmonary Valve Korean Multicenter Study
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
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 Pulmon
Brief Summary: The purpose of this study is to evaluate the safety and effectiveness of the TPV in patients with pulmonary valve dysfunction.
Detailed Summary: 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.
Sponsor: Seoul National University Hospital
Current Primary Outcome:
- Hemodynamic functional improvement at 6month [ Time Frame: 6 months ]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 [ Time Frame: 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Procedural success [ Time Frame: 5 days ]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 function [ Time Frame: 5 years ]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 [ Time Frame: 5 years ]
- New York Heart Association (NYHA) functional classification [ Time Frame: 5 years ]
- Stent fracture [ Time Frame: 5 years ]
- Catheter reintervention on TPV [ Time Frame: 5 years ]
- Reoperation [ Time Frame: 5 years ]
- Procedural / Device related serious adverse events [ Time Frame: 5 years ]
- Death (all cause / procedural / device-related) [ Time Frame: 5 years ]
- Other adverse events [ Time Frame: 5 years ]
- Pulmonary regurgitant fraction [ Time Frame: 5 years ]
Original Secondary Outcome: Same as current
Information By: Seoul National University Hospital
Dates:
Date Received: April 7, 2017
Date Started: March 22, 2017
Date Completion: December 2023
Last Updated: April 7, 2017
Last Verified: April 2017