REmote MOnitoring Transmission Evaluation of IPGs
Summary
The purpose of this study is to evaluate the potential clinical and economic benefits of using CareLink remote management for pacemaker follow-up.
Study Objectives include:
1. To determine clinician perceived quality of care for CareLink remote follow-up.
2. To determine patient satisfaction with CareLink follow-up.
3. To estimate the time required to perform patient follow-up via CareLink remote transmissions.
4. To determine the percentage of regular CareLink follow-ups that do not require further in-clinic review of the patient.
5. To estimate potential patient cost avoidance for one year of follow up incorporating CareLink.
6. To evaluate compliance to scheduled CareLink transmissions with the remote management system
This is a non-randomized, multi-center, prospective study in which 120 patients who have a pacemaker are enrolled into the study and receive a CareLink monitor. Patients will replace their regularly scheduled pacemaker clinic follow-up visits with a CareLink remote transmission for 12months.
Patients will require a test transmission within 1 month after they receive their CareLink monitor. Afterwards, patients are followed via CareLink transmissions as per their usual clinic schedule for 12 months.
Study Design
Control: Uncontrolled, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Conditions
Pacemaker
Intervention
CareLink Remote Monitoring
Location
Kelowna General Hospital
Kelowna
British Columbia
Canada
Status
Completed
Source
Medtronic
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00631709
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Remote Consultation
Consultation via remote telecommunications, generally for the purpose of diagnosis or treatment of a patient at a site remote from the patient or primary physician.
Fetal Monitoring
Physiologic or biochemical monitoring of the fetus. It is usually done during LABOR, OBSTETRIC and may be performed in conjunction with the monitoring of uterine activity. It may also be performed prenatally as when the mother is undergoing surgery.
Cd-i
An optical disk storage system used on specialized players that combine the functions of computer and CD player in a self-contained box, designed to be connected to a television set and a home stereo for video and sound output. The player is controlled with a hand-held remote unit resembling a television remote control. (J Allied Health 1993 Winter;22(1):131-8)
Monitoring, Physiologic
The continuous measurement of physiological processes, blood pressure, heart rate, renal output, reflexes, respiration, etc., in a patient or experimental animal; includes pharmacologic monitoring, the measurement of administered drugs or their metabolites in the blood, tissues, or urine.
Uterine Monitoring
Measurement or recording of contraction activity of the uterine muscle. It is used to determine progress of LABOR, OBSTETRIC and assess status of pregnancy. It is also used in conjunction with FETAL MONITORING to determine fetal response to stress of maternal uterine contractions.
Clinical Trials
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PubMed Articles
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Laparoscopic-Assisted Retrieval of Migrated Intra-Abdominal Pacemaker Generator.
A 5-year-old boy born with a congenital heart defect had insertion of an epicardial pacemaker that was found on routine evaluation to have been displaced into the rectovesical pouch. He underwent tran...
