PREFER (Pacemaker Remote Follow-Up Evaluation and Review)

Study Overview
=================
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: 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 Ventricular pacing that has increased by 30 percent (relative) since the last device interrogation 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 Runs of non-sustained ventricular tachycardia (NSVT) greater than 5 beats New onset of AT/AF among patients with no history of AT/AF Loss of atrial capture Loss of ventricular capture Increase in atrial pacing voltage threshold greater than 1 volt (V) Increase in ventricular pacing voltage threshold greater than 1 volt (V) & 11. Significant change in atrial or ventricular lead impedance, defined as any of the following: Less than 200 or greater than 2000 ohms (Ω) Unstable lead impedance deemed to be clinically actionable Greater than 50 percent change in lead impedance since last interrogation 12. Elective Replacement Indicator (ERI)/Battery End of Life (EOL) indicators

Official Title
-----------------
Pacemaker Remote Follow-up Evaluation and Review

Conditions
-----------------
Bradycardia, Arrhythmia

Intervention / Treatment
-----------------
* Other: Transtelephonic monitoring (TTM)
* Other: Medtronic CareLink® Network


Participation Criteria
=================
Eligibility Criteria
-----------------
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)
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Transtelephonic monitoring at 2 month intervals | Other: Transtelephonic monitoring (TTM)<br>* 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.<br>|
| Active Comparator: Remote<br>Medtronic CareLink® Network remote pacemaker interrogation at 3 month intervals | Other: Medtronic CareLink® Network<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | One year post-enrollment | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Remote Follow Up, Diagnostic, Bradycardia