Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00116987
Status:
TERMINATED
Last Update Posted:
2015-06-15
First Post:
2005-06-30
Brief Title:
Dual Chamber Versus Single Chamber Cardiac Pacing in People 80 Years of Age and Older
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
Pacing the Octogenarian Plus Population POPP A Comparison of Physiologic Versus Ventricular Pacing in Those Who Are 80 Years of Age and Older
Status:
TERMINATED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to recruit adequate number of participants in required time frame
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Of the 19000 pacemakers implanted across Canada in 2002 13 of them were for patients 80 years and older This is the fastest growing segment of our population yet no study has specifically been done in this age group to determine the optimal pacing mode
We wish to determine whether dual chamber or single chamber pacing is associated with a reduction in emergency room visits or hospitalizations for cardiovascular causes eg congestive heart failure CHF atrial fibrillation AF resulting in improved quality of life
We wish to determine whether dual chamber or single chamber pacing is associated with a reduction in emergency room visits or hospitalizations for cardiovascular causes eg congestive heart failure CHF atrial fibrillation AF resulting in improved quality of life
Detailed Description:
Many patients who are 80 years of age and older develop AF or CHF Physiologic pacing has been shown to prevent AF compared to ventricular pacing Whether prevention of AF and CHF by physiologic pacing reduces emergency room visits or hospitalizations for cardiovascular causes in this population in unknown
The investigators wish to determine the optimal pacing mode for this patient population that would enable optimal management of cardiovascular problems resulting in improved quality of life and minimizing use of health care facilities
Patients recruited to the study will be randomized to either DDDR or VVIR pacing and followed in the clinic every 6 months for the 3 years of the study
The investigators wish to determine the optimal pacing mode for this patient population that would enable optimal management of cardiovascular problems resulting in improved quality of life and minimizing use of health care facilities
Patients recruited to the study will be randomized to either DDDR or VVIR pacing and followed in the clinic every 6 months for the 3 years of the study
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