PREFER (Pacemaker Remote Follow-Up Evaluation and Review)

Medtronic Cardiac Rhythm and Heart Failure980 enrolled

Overview

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).

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

980

Conditions

Bradycardia Arrhythmia

Interventions

Transtelephonic monitoring (TTM)OTHER

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.

Medtronic CareLink® NetworkOTHER

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Patient has been previously implanted with a dual-chamber or single-chamber EnPulse®, Kappa 900®, or Adapta® device * Patient agrees to complete all required follow-up transmissions and in-office visits * Patient is capable of operating the TTM monitor and Medtronic CareLink monitor Exclusion Criteria: * Patient is an immediate candidate for an implantable cardioverter defibrillator (ICD)

Locations (45)

Outcomes

Primary Outcomes

Percentage of Participants With First Diagnosis of Clinically Actionable Events (CAE) at 12 Months

Clinically Actionable Events (CAE) are 12 events that were identified based on their relation to other comorbidities that may increase the risk of a serious cardiac event. The CAEs consist of several arrhythmias and device performance parameters such as: Atrial Tachycardia/Atrial Fibrillation (AT/AF) and loss of capture.