PREFER (Pacemaker Remote Follow-Up Evaluation and Review)

Not Applicable

Completed

Conditions: Bradycardia
Arrhythmia

Registration Number: NCT00294645

Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

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 (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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 980

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With First Diagnosis of Clinically Actionable Events (CAE) at 12 Months	One year post-enrollment	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.

Secondary Outcome Measures

Name	Time	Method
Proportion of Actions Taken in Response to the Diagnosis of Clinically Actionable Events	One year post-enrollment	Actions categories include: Referral, Office Visit, Medication (Med) Change, Hospitalization, Emergency Room (ER) Visit, Device Reprogrammed, System Modification, Increase Monitoring, Other
Percentage of Participants With First Diagnosis of New Onset Atrial Tachycardia/Atrial Fibrillation (AT/AF) at 12 Months	One year post-enrollment	Compare time to first diagnosis in Remote and Control arms
Percentage of Participants With First Diagnosis of Sensed Ventricular Rate Greater Than 100 Beats Per Minute (BPM) During Atrial Tachycardia/Atrial Fibrillation at 12 Months	One year post-enrollment	Compare time to diagnosis in Control and Remote arms
Percentage of Participants With First Diagnosis of Atrial Tachycardia/Atrial Fibrillation Greater Than 48 Hours at 12 Months	One year post-enrollment	Compare time to diagnosis in Control and Remote arms
Percentage of Participants With First Diagnosis of Ventricular Pacing Increase Greater Than 30 Percent at 12 Months	One year post-enrollment	Compare time to first diagnosis in Control and Remote arms
Percentage of Participants With First Diagnosis of Non-sustained Ventricular Tachycardia at 12 Months	One year post-enrollment	Compare time to first diagnosis in Control and Remote arms
Percentage of Participants With First Diagnosis of Loss of Atrial Capture at 12 Months	One year post-enrollment	Compare time to first diagnosis in Control and Remote arms
Percentage of Participants With First Diagnosis of Loss of Ventricular Capture at 12 Months	One year post-enrollment	Compare time to first diagnosis in Remote and Control arms
Percentage of Participants With an Increase in Atrial Pacing Voltage Threshold Greater Than 1 Volt (V) at 12 Months	One year post-enrollment	Compare time to first diagnosis in Remote and Control arms
Percentage of Participants With an Increase in Ventricular Pacing Voltage Threshold Greater Than 1 Volt (V) at 12 Months	One year post-enrollment	Compare time to first diagnosis in Control and Remote arms
Percentage of Participants With First Diagnosis of Change in Atrial Lead Impedance at 12 Months	One year post-enrollment	Compare time to first diagnosis in Control and Remote arms
Percentage of Participants With First Diagnosis of Change in Ventricular Lead Impedance at 12 Months	One year post-enrollment	Compare time to first diagnosis in Control and Remote arms
Percentage of Participants With First Diagnosis of Elective Replacement Indicator/Battery End of Life (ERI/EOL) at 12 Months	One year post-enrollment	Compare time to first diagnosis in Control and Remote arms