At a glance
ClinicalIndex Comparison RecordN/ACompleted· 81 enrolled
Drug / intervention
SAPIEN Transcatheter Valve Implantationdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Implantation of the SAPIEN Transcatheter Heart Valve (THV) in the Pulmonic Position
In Brief
A clinical study evaluating SAPIEN Transcatheter Valve Implantation for Pulmonary Valve Insufficiency and 4 related conditions. Completed, enrolled 81 participants across 7 sites.
Detailed Summary
To assess the safety and effectiveness of pulmonic THV implantation in subjects with dysfunctional RVOT conduit requiring treatment for moderate or severe pulmonary regurgitation (≥3+ pulmonary regurgitation) and/or RVOT conduit obstruction (mean gradient of \>=35mmHg) by TTE.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Valve Insufficiency, Pulmonary Regurgitation, Dysfunctional RVOT Conduit, Pulmonary Obstruction, Pulmonary Stenosis
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2008
First PostedMay 2008
Primary CompletionNov 2015
Study CompletionDec 2019
TodayJul 2026
First PostedMay 13, 2008
Enrollment StartApr 8, 2008
Primary CompletionNov 1, 2015
Study CompletionDec 31, 2019
TodayJul 2, 2026
Enrollment to primary: 7.6 yearsPosted 18.1 years ago
Interventions
SAPIEN Transcatheter Valve Implantationdevice
Device Implantation