Ignite Creation Date:
2025-12-18 @ 8:44 AM
Ignite Modification Date:
2025-12-18 @ 8:44 AM
Study NCT ID:
NCT05440071
Status:
None
Last Update Posted:
2022-06-30 00:00:00
First Post:
2022-06-27 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PoSt-market Assessment on Safety and Performance of J-sHAPed xFINE Lead
Sponsor:
None
Organization:
Study Overview
Official Title:
PoSt-market Assessment on Safety and Performance of J-sHAPed xFINE Lead
Status:
None
Status Verified Date:
2022-06
Last Known Status:
NOT_YET_RECRUITING
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:
SHAPE
Brief Summary:
The primary objective of this study is to evaluate the safety and the electrical performances of the right atrial J-shape (JX model) XFINE endovascular passive lead at 3 months post implant.
Detailed Description:
None
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?: