Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00294645
Status:
COMPLETED
Last Update Posted:
2010-10-19
First Post:
2006-02-20
Brief Title:
PREFER Pacemaker Remote Follow-Up Evaluation and Review
Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Organization:
Medtronic Cardiac Rhythm and Heart Failure
Study Overview
Official Title:
Pacemaker Remote Follow-up Evaluation and Review
Status:
COMPLETED
Status Verified Date:
2010-10
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 the study is to compare remote pacemaker follow-up to current standard of care follow-up The study will compare the rate of first diagnosis of clinically actionable events between patients who utilize the Medtronic Carelink Network Remote arm versus patients who are followed via routine office visits augmented by transtelephonic monitoring TTMControl arm
Detailed Description:
The Clinically Actionable Events CAE were identified based on their relation to other comorbidities that may increase the risk of a serious cardiac event The defined events are
1 Atrial TachycardiaAtrial Fibrillation ATAF episodes of greater than 48 hours defined as two consecutive days in which the device records at least 18 hours of ATAF per day
2 Ventricular pacing that has increased by 30 percent relative since the last device interrogation
3 A sensed ventricular response of greater than 100 beats per minute BPM during atrial tachyarrhythmia for at least 20 percent of the time since the previous device interrogation
4 Runs of non-sustained ventricular tachycardia NSVT greater than 5 beats
5 New onset of ATAF among patients with no history of ATAF
6 Loss of atrial capture
7 Loss of ventricular capture
8 Increase in atrial pacing voltage threshold greater than 1 volt V
9 Increase in ventricular pacing voltage threshold greater than 1 volt V
10 11 Significant change in atrial or ventricular lead impedance defined as any of the following
1 Less than 200 or greater than 2000 ohms Ω
2 Unstable lead impedance deemed to be clinically actionable
3 Greater than 50 percent change in lead impedance since last interrogation
12 Elective Replacement Indicator ERIBattery End of Life EOL indicators
1 Atrial TachycardiaAtrial Fibrillation ATAF episodes of greater than 48 hours defined as two consecutive days in which the device records at least 18 hours of ATAF per day
2 Ventricular pacing that has increased by 30 percent relative since the last device interrogation
3 A sensed ventricular response of greater than 100 beats per minute BPM during atrial tachyarrhythmia for at least 20 percent of the time since the previous device interrogation
4 Runs of non-sustained ventricular tachycardia NSVT greater than 5 beats
5 New onset of ATAF among patients with no history of ATAF
6 Loss of atrial capture
7 Loss of ventricular capture
8 Increase in atrial pacing voltage threshold greater than 1 volt V
9 Increase in ventricular pacing voltage threshold greater than 1 volt V
10 11 Significant change in atrial or ventricular lead impedance defined as any of the following
1 Less than 200 or greater than 2000 ohms Ω
2 Unstable lead impedance deemed to be clinically actionable
3 Greater than 50 percent change in lead impedance since last interrogation
12 Elective Replacement Indicator ERIBattery End of Life EOL indicators
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