NCT00294645

PREFER (Pacemaker Remote Follow-Up Evaluation and Review)

Pacemaker Remote Follow-up Evaluation and Review

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 980 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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 (TTM)(Control 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 Tachycardia/Atrial Fibrillation (AT/AF) episodes of greater than 48 hours defined as two consecutive days in which the device records at least 18 hours of AT/AF 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 AT/AF among patients with no history of AT/AF 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 (ERI)/Battery End of Life (EOL) indicators

Conditions

• Bradycardia
• Arrhythmia

Interventions

Type	Name	Description
OTHER	Transtelephonic monitoring (TTM)	TTM conducted at 2 month intervals. For patients with dual-chamber pacemakers, an in-office visit was required at 6 months (rather than TTM transmission for patients with single-chamber pacemakers). Follow-up frequency established to mimic best case standard of care when utilizing TTM for follow-up. A 12-month in-office visit completed the follow-up period.
OTHER	Medtronic CareLink® Network	Remote pacemaker interrogation conducted at 3 month intervals. Follow-up frequency established to mimic best case standard of care when utilizing implantable cardioverter defibrillator (ICD) remote interrogation for follow-up. A 12-month in-office visit completed the follow-up period.

Timeline

• Start date: 2004-04-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2006-02-22
• Last updated: 2010-10-19
• Results posted: 2010-10-19

Locations

45 sites across 1 country: United States