Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00161538
Status:
COMPLETED
Last Update Posted:
2006-10-20
First Post:
2005-09-09
Brief Title:
Pacing of the Atria in Sick Sinus Syndrome Trial Preventive Strategies for Atrial Fibrillation
Sponsor:
Medtronic BRC
Organization:
Medtronic BRC
Study Overview
Official Title:
A Randomized Prospective Multicenter Study to Examine the Optimal Position of the Atrial Leads for Therapy of the Sinus Node Syndrome
Status:
COMPLETED
Status Verified Date:
2006-10
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:
The purpose of this study is to determine which of 4 lead positions is most effective for pacemaker patients with Sick Sinus Syndrome in order to avoid development of atrial fibrillation
Detailed Description:
The incidence of Atrial Fibrillation AF in Sick Sinus Syndrome patients treated with pacing is quite high As AF can cause dizziness fatigue thromboembolism and ischemic stroke it is clinically relevant Due to earlier publications pacing modes and lead placement seem to influence the incidence of AF In this study the incidence of AF will be compared between 4 different atrial lead positions
1 Free atrial wall
2 right atrial appendage
3 coronary sinus-os
4 Dual site right atrial pacing b plus c
The following primary parameters will be evaluated during the study period of 2 years after implantation
1 Amounts of AF episodes with a duration of 48 hours
2 Amounts of AF episodes with a duration of 30 minutes
3 Consultations of physicians due to AF Secondarily AF burden Incidence of AF in total Quality of Life implant duration and complications will be evaluated
1 Free atrial wall
2 right atrial appendage
3 coronary sinus-os
4 Dual site right atrial pacing b plus c
The following primary parameters will be evaluated during the study period of 2 years after implantation
1 Amounts of AF episodes with a duration of 48 hours
2 Amounts of AF episodes with a duration of 30 minutes
3 Consultations of physicians due to AF Secondarily AF burden Incidence of AF in total Quality of Life implant duration and complications will be evaluated
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