Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00123344
Status:
COMPLETED
Last Update Posted:
2008-12-11
First Post:
2005-07-20
Brief Title:
Atrial Pacing for Termination and Prevention of Atrial Fibrillation
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
Atrial Pacing for Termination and Prevention of Atrial Fibrillation
Status:
COMPLETED
Status Verified Date:
2008-12
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:
Atrial fibrillation AF is the most common sustained arrhythmia and is associated with substantial morbidity and mortality Present treatment strategies are aimed at termination of AF and prevention of AF recurrence using antiarrhythmic drugs or heart rate control drugs Drugs are not always well tolerated so atrial pacing as a strategy for prevention of atrial tachyarrhythmias is being explored
The AT501 pacemaker has both prevention and treatment algorithms for atrial tachyarrhythmias The investigators wish to determine whether these special features over the long term decrease the amount of time the person experiences AF
The AT501 pacemaker has both prevention and treatment algorithms for atrial tachyarrhythmias The investigators wish to determine whether these special features over the long term decrease the amount of time the person experiences AF
Detailed Description:
There are some clinical and experimental data to suggest that atrial overdrive pacing should prevent AF In our pacemaker population with tachy-brady syndrome and in the PA3 study population we observed that AF frequently clusters and may recur early following an episode of AF
We are conducting a randomized trial of both prevention algorithms and antitachycardia pacing ATP therapies for the treatment of atrial tachyarrhythmias and thereby prevention of AF over the longterm
Patients with a history of paroxysmal AF who received an AT501 pacemaker for the treatment of bradycardia will be randomized to having both the prevention and therapy algorithms ON both OFF or having only the therapy algorithms ON They will be followed every 3 months for 1 year then every 6 months for an 2 additional years Recurrence and frequency of AF will be determined over time based on data retrieved from the device at each follow-up visit
We are conducting a randomized trial of both prevention algorithms and antitachycardia pacing ATP therapies for the treatment of atrial tachyarrhythmias and thereby prevention of AF over the longterm
Patients with a history of paroxysmal AF who received an AT501 pacemaker for the treatment of bradycardia will be randomized to having both the prevention and therapy algorithms ON both OFF or having only the therapy algorithms ON They will be followed every 3 months for 1 year then every 6 months for an 2 additional years Recurrence and frequency of AF will be determined over time based on data retrieved from the device at each follow-up visit
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