PREFER (Pacemaker Remote Follow-Up Evaluation and Review)

Arrhythmia Clinical Trial

Official title:

Pacemaker Remote Follow-up Evaluation and Review

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00294645
• Other study ID #: 701
• Status: Completed
• Phase: N/A
• First received: February 20, 2006
• Last updated: October 1, 2010
• Start date: April 2004
• Est. completion date: April 2008

Study information

• Verified date: October 2010
• Source: Medtronic Cardiac Rhythm Disease Management
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 980
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arrhythmia
• Bradycardia

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm Disease Management	Medtronic

Country where clinical trial is conducted

United States, 

References & Publications (1)

Chen J, Wilkoff BL, Choucair W, Cohen TJ, Crossley GH, Johnson WB, Mongeon LR, Serwer GA, Sherfesee L. Design of the Pacemaker REmote Follow-up Evaluation and Review (PREFER) trial to assess the clinical value of the remote pacemaker interrogation in the management of pacemaker patients. Trials. 2008 Apr 3;9:18. doi: 10.1186/1745-6215-9-18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	One year post-enrollment	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No