Ignite Creation Date:
2024-07-17 @ 11:14 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06474819
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-06-19
Brief Title:
Left Septal or Deep Septal Pacing to Prevent Pacing-induced Cardiomyopathy
Sponsor:
Institut dInvestigació Biomèdica de Bellvitge
Organization:
Institut dInvestigació Biomèdica de Bellvitge
Study Overview
Official Title:
Left Septal or Deep Septal Pacing to Prevent Pacing-induced Cardiomyopathy
Status:
RECRUITING
Status Verified Date:
2024-07
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:
DEEP
Brief Summary:
Multicenter randomized controlled trial which will include patients with left ventricular ejection fraction 50 requiring a first implant of a cardiac pacemaker with expected high pacing percentages
Patients will be randomized 11 to right ventricular apical pacing vs left septal or deep septal pacing The primary endpoint will be pacing-induced cardiomyopathy during the first year of follow-up
Patients will be randomized 11 to right ventricular apical pacing vs left septal or deep septal pacing The primary endpoint will be pacing-induced cardiomyopathy during the first year of follow-up
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None