N/A
N=897
PREFER (Pacemaker Remote Follow-Up Evaluation and Review)
Bradycardia · Arrhythmia
Bottom Line
View on ClinicalTrials.gov: NCT00294645 ↗Enrolled (actual)
897
Serious AEs
—
Results posted
Oct 2010
Primary outcome: Primary: Percentage of Participants With First Diagnosis of Clinically Actionable Events (CAE) at 12 Months — 35; 47 Percentage of participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transtelephonic monitoring (TTM) (Other); Medtronic CareLink® Network (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With First Diagnosis of Clinically Actionable Events (CAE) at 12 Months |
35; 47 | <0.0001 sig |
| SECONDARY Proportion of Actions Taken in Response to the Diagnosis of Clinically Actionable Events |
0.005; 0.006; 0.016; 0.043; 0.053; 0.05 | — |
| SECONDARY Percentage of Participants With First Diagnosis of New Onset Atrial Tachycardia/Atrial Fibrillation (AT/AF) at 12 Months |
8; 15 | — |
| 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 |
9; 12 | — |
| SECONDARY Percentage of Participants With First Diagnosis of Atrial Tachycardia/Atrial Fibrillation Greater Than 48 Hours at 12 Months |
9; 10 | — |
| SECONDARY Percentage of Participants With First Diagnosis of Ventricular Pacing Increase Greater Than 30 Percent at 12 Months |
4; 8 | — |
| SECONDARY Percentage of Participants With First Diagnosis of Non-sustained Ventricular Tachycardia at 12 Months |
21; 26 | — |
| SECONDARY Percentage of Participants With First Diagnosis of Loss of Atrial Capture at 12 Months |
0; 0 | — |
| SECONDARY Percentage of Participants With First Diagnosis of Loss of Ventricular Capture at 12 Months |
0; 1 | — |
| SECONDARY Percentage of Participants With an Increase in Atrial Pacing Voltage Threshold Greater Than 1 Volt (V) at 12 Months |
0; 1 | — |
| SECONDARY Percentage of Participants With an Increase in Ventricular Pacing Voltage Threshold Greater Than 1 Volt (V) at 12 Months |
1; 1 | — |
| SECONDARY Percentage of Participants With First Diagnosis of Change in Atrial Lead Impedance at 12 Months |
0; 0 | — |
| SECONDARY Percentage of Participants With First Diagnosis of Change in Ventricular Lead Impedance at 12 Months |
1; 1 | — |
| SECONDARY Percentage of Participants With First Diagnosis of Elective Replacement Indicator/Battery End of Life (ERI/EOL) at 12 Months |
0; 0 | — |
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).
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)
Data sourced from ClinicalTrials.gov (NCT00294645). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.