NCT00631709

Brief 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. 1.To determine clinician perceived quality of care for CareLink remote follow-up.
  2. 2.To determine patient satisfaction with CareLink follow-up.
  3. 3.To estimate the time required to perform patient follow-up via CareLink remote transmissions.
  4. 4.To determine the percentage of regular CareLink follow-ups that do not require further in-clinic review of the patient.
  5. 5.To estimate potential patient cost avoidance for one year of follow up incorporating CareLink.
  6. 6.To evaluate compliance to scheduled CareLink transmissions with the remote management system

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2008

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 10, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

April 26, 2018

Status Verified

April 1, 2018

Enrollment Period

1.7 years

First QC Date

March 3, 2008

Last Update Submit

April 24, 2018

Conditions

Pacemaker

Study Arms (1)

1

EXPERIMENTAL

Pacemaker Patients

Other: CareLink Remote Monitoring

Interventions

CareLink Remote MonitoringOTHER

Substitution of CareLink Remote Monitoring of Pacemakers for in-clinic pacemaker follow-up visits

1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who have received a market released Medtronic pacemaker with automatic threshold management features for all active leads.
  • Patients who have been implanted with their current pacemaker for at least 3 months.
  • Patients who are willing, or who have caregivers willing, to use the Medtronic CareLink Monitor.
  • Patients who are willing and able to sign an IRB/MEC approved patient informed consent.

You may not qualify if:

  • Patients participating in another study that would affect the objectives of this study
  • Patients who have already previously used a Medtronic CareLink Monitor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Kelowna General Hospital

Kelowna, British Columbia, Canada

Location

Southlake Regional Hospital

Newmarket, Ontario, Canada

Location

CHUQ, L'Hotel Dieu de Quebec

Québec, Quebec, Canada

Location

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2008

First Posted

March 10, 2008

Study Start

March 1, 2008

Primary Completion

November 1, 2009

Study Completion

February 1, 2010

Last Updated

April 26, 2018

Record last verified: 2018-04

Locations

CA(3)