Ignite Creation Date:
2025-12-25 @ 3:07 AM
Ignite Modification Date:
2026-01-03 @ 11:35 PM
Study NCT ID:
NCT02700633
Status:
UNKNOWN
Last Update Posted:
2016-03-07
First Post:
2016-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Permanent Pacemaker Status Confer Mortality Benefit in the Short Term Post TAVI
Sponsor:
Royal Sussex County Hospital
Organization:
Study Overview
Official Title:
Does Permanent Pacemaker Status Confer Mortality Benefit in the Short Term Post TAVI
Status:
UNKNOWN
Status Verified Date:
2016-03
Last Known Status:
ACTIVE_NOT_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:
None
Brief Summary:
Pacemaker requirement in the immediate post procedure phase following TAVI is approximately 20% depending on device type and patient characteristics. There is a signal from recent studies suggesting increased risk of sudden cardiac / unexplained death in the first 30-60 days. This study aims to address whether there is a mortality advantage to having a pacemaker in the short term
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: