Pulsta® Transcatheter Pulmonary Valve Korean Multicenter Study (NCT03110861) | Clinical Trial Compass
CompletedNot Applicable
Pulsta® Transcatheter Pulmonary Valve Korean Multicenter Study
South Korea15 participantsStarted 2017-03-22
Plain-language summary
The purpose of this study is to evaluate the safety and effectiveness of the TPV in patients with pulmonary valve dysfunction.
Who can participate
Age range10 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Hemodynamic functional improvement at 6month
Timeframe: 6 months
2
Procedural / Device related serious adverse events at 6month