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General |
Study Status |
Other |
Application Number / Requirement Number |
P000049 / PAS001 |
Date Original Protocol Accepted |
04/19/2002
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Date Current Protocol Accepted |
04/19/2002
|
Study Name |
Prospective VSD Registry
|
Device Name |
CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD
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General Study Protocol Parameters |
Study Design |
Prospective & Retrospective Study
|
Data Source |
New Data Collection
|
Comparison Group |
No Control
|
Analysis Type |
Descriptive
|
Study Population |
Neonate: 1-28 days,
Infant: 29 days-2 yrs,
Child: 2-12 yrs,
Adolescent: 13-18 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
Detailed Study Protocol Parameters |
Study Objectives |
This study is a prospective registry to evaluate the ongoing occurrence of major complications related to device or procedure, shunt closure status and fracture detection.
|
Study Population |
The CardioSEAL Septal Occlusion System with QwikLoad is indicated for use in adult and pediatric patients with complex ventricular septal defects, which are of significant size that they warrant closure and are considered to be at high risk for standard transatrial or transarterial surgical closure based on anatomical conditions and/or based on overall medical condition. The study population is consistent with the indications for use. It includes patients of all ages with complex ventricular septal defects, who are at high risk for surgical closure due to a high risk anatomical condition or high risk medical condition.
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Sample Size |
55 patients, 18 sites
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Key Study Endpoints |
Data collected will include baseline, procedural, and annual follow-up data. This includes demographics, diagnosis, prior procedures, devices used, defect size, and procedural success. The collection of the occurrence of major complications, such as embolization, device explant, or death will be collected annually. Recommended annual evaluations include a history and physical exam, an echocardiogram, and a chest x-ray. A fluoroscopy is recommended if the x-ray is "uncertain".
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Follow-up Visits and Length of Follow-up |
Annual follow-up will be solicited for a period of 5 years after implantation.
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