Efficacy and Safety Evaluation of Transcatheter Pulmonary Valve Implantation for Right Ventricular Outflow Tract (RVOT) Stenosis After Congenital Heart Defect Surgical Correction Complicated With Severe Pulmonary Regurgitation
Sponsor study identifier
interventional
44
1 country
1
Study Start
February 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
A prospective, non-randomized, multi-center clinical study of the Venus P-valve for the treatment of RVOT stenosis with pulmonary regurgitation after surgery of congenital heart defect.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 11, 2014
Actual (reported)February 2014
Date type not reportedThis date has not been verified as actual or estimated.
February 26, 2014
Actual (reported)February 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Improvement rate of RVEDV at 6 months post-procedure.
The improvement is defined as the RVEDVI≤108mL/m2 measured with CMR.
At 6 months post-implantation of Venus-P valve
Safety Endpoints
From the date of implantation until 12 months post-procedure
Feasibility and Performance Endpoints
Day 7 post-implantation
Secondary Endpoints
From the date of valve implantation till 12 months post-procedure
Single arm of percutaneous implantation of Venus-P valve for treating RVOT stenosis
Percutaneous implantation of Venus-P valve to treat RVOT stenosis patients
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032, China
Junbo Ge, Prof., MD.
Fudan University
First Submitted
January 11, 2014
First Posted
February 26, 2014
Study Start
February 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2015
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 6, 2015
Record last verified: 2015-01
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Source: ClinicalTrials.gov.
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