Ignite Creation Date:
2024-05-06 @ 2:38 AM
Last Modification Date:
2024-10-26 @ 11:21 AM
Study NCT ID:
NCT02097420
Status:
COMPLETED
Last Update Posted:
2024-06-13
First Post:
2014-03-24
Brief Title:
HALO A Single Arm Prospective Investigation of the SJM Masters HP 15mm Rotatable Mechanical Heart Valve
Sponsor:
Abbott Medical Devices
Organization:
Abbott Medical Devices
Study Overview
Official Title:
HALO Clinical Study A Single Arm Prospective Non-randomized Multi Center Investigation of the SJM Masters HP 15mm Rotatable Mechanical Heart Valve
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to provide evidence of safety and effectiveness of the study valve The rationale is to offer a replacement mitral valve for patients with anatomy that is too small for the currently commercially available valves ranging in size from 16mm to 37mm
20 subjects were enrolled as part of the IDE cohort and an additional 3 were enrolled under continued access
20 subjects were enrolled as part of the IDE cohort and an additional 3 were enrolled under continued access
Detailed Description:
The study is a single arm prospective non-randomized multi-center clinical investigation
The objective of this study is to evaluate the safety and effectiveness of the 15mm MHV in subjects five years or less of age with a diseased damaged or malfunctioning mitral heart valve The objective will be evaluated by assessing valve-related adverse events subject survival subject growth and echocardiogram assessment of hemodynamic function through the five year follow-up visit as long as the valve remains implanted
The objective of this study is to evaluate the safety and effectiveness of the 15mm MHV in subjects five years or less of age with a diseased damaged or malfunctioning mitral heart valve The objective will be evaluated by assessing valve-related adverse events subject survival subject growth and echocardiogram assessment of hemodynamic function through the five year follow-up visit as long as the valve remains implanted
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None