Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00182416
Status:
COMPLETED
Last Update Posted:
2007-10-19
First Post:
2005-09-13
Brief Title:
Second Canadian Trial of Physiologic Pacing CTOPP II Pilot Trial
Sponsor:
Hamilton Health Sciences Corporation
Organization:
McMaster University
Study Overview
Official Title:
Second Canadian Trial of Physiologic Pacing CTOPP II Pilot Trial
Status:
COMPLETED
Status Verified Date:
2007-10
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:
Pacemaker therapy has been recognized as effective for the control of sinus and atrio-ventricular AV node dysfunction Single chamber pacing when compared with dual chamber pacing has numerous advantages of low complication rates lower cost better longevity with non-inferiority in the quality of life and hard outcomes proven in direct randomized comparisons However comparison between single and dual chamber pacers was never adequate since not more then half of the patients in the trials were actually using pacemakers for the majority of the time Routine dual chamber pacing using a right ventricle apical lead is also associated with significant increase in peri-operative and remote complications Some of these complications may be related to ventricular desynchronization secondary to the pacing location which is potentially avoidable by using biventricular pacing A randomized trial which will compare single chamber rate responsive pacing to the best available modification of dual chamber pacing biventricular pacing in suitable patients is therefore warranted
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?:
None