PREFER (Pacemaker Remote Follow-Up Evaluation and Review)

Pacemaker Remote Follow-up Evaluation and Review

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00294645

Enrollment

980

Registered

2006-02-22

Start date

2004-04-30

Completion date

2008-04-30

Last updated

2010-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrhythmia, Bradycardia

Keywords

Remote Follow Up, Diagnostic, Bradycardia

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

Interventions

OTHERTranstelephonic 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.

OTHERMedtronic 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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 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
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

Countries

United States

Participant flow

Recruitment details

Patients were enrolled from May 24, 2004 through March 30, 2007 at cardiology and electrophysiology clinics in the United States.

Pre-assignment details

Of the 980 patients enrolled, 83 were excluded from analysis: incomplete informed consent forms (n=8), devices incompatible with the Medtronic CareLink® Network (n=7), from research centers that closed prior to cleaning data to the extent necessary for inclusion in cohort (n=67), and exited prior to Baseline assessment (n=1).

Participants by arm

Arm	Count
Standard of Care With TTM Pacemaker patients followed by transtelephonic monitoring at 2 month intervals	295
Remote Pacemaker Interrogation Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals	602
Total	897

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Death	10	18
Overall Study	Lost to Follow-up	1	10
Overall Study	Other	4	10
Overall Study	Physician Decision	15	20
Overall Study	Withdrawal by Subject	18	34

Baseline characteristics

Characteristic	Remote Pacemaker Interrogation	Standard of Care With TTM	Total
Age, Categorical <=18 years	16 Participants	9 Participants	25.0 Participants
Age, Categorical >=65 years	417 Participants	212 Participants	629.0 Participants
Age, Categorical Between 18 and 65 years	169 Participants	74 Participants	243.0 Participants
Age Continuous	68 years STANDARD_DEVIATION 16.7	69 years STANDARD_DEVIATION 16.9	68 years STANDARD_DEVIATION 16.8
Region of Enrollment United States	602 participants	295 participants	897.0 participants
Sex: Female, Male Female	290 Participants	153 Participants	443.0 Participants
Sex: Female, Male Male	312 Participants	142 Participants	454.0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 0	0 / 0
serious Total, serious adverse events	0 / 0	0 / 0

Outcome results

Primary

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.