We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

REmote MOnitoring Transmission Evaluation of IPGs (REMOTE-IPG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00631709
Recruitment Status : Completed
First Posted : March 10, 2008
Last Update Posted : April 8, 2015
Sponsor:
Information provided by (Responsible Party):
Medtronic

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. 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.


Condition or disease Intervention/treatment Phase
Pacemaker Other: CareLink Remote Monitoring Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: REmote MOnitoring Transmission Evaluation of IPGs
Study Start Date : March 2008
Primary Completion Date : November 2009
Study Completion Date : February 2010

Arm Intervention/treatment
Experimental: 1
Pacemaker Patients
Other: CareLink Remote Monitoring
Substitution of CareLink Remote Monitoring of Pacemakers for in-clinic pacemaker follow-up visits




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00631709


Locations
Canada, British Columbia
Kelowna General Hospital
Kelowna, British Columbia, Canada
Canada, Ontario
Southlake Regional Hospital
Newmarket, Ontario, Canada
Canada, Quebec
CHUQ, L'Hotel Dieu de Quebec
Quebec City, Quebec, Canada
Sponsors and Collaborators
Medtronic

Responsible Party: Medtronic
ClinicalTrials.gov Identifier: NCT00631709     History of Changes
Other Study ID Numbers: REMOTE-IPG 2008
First Posted: March 10, 2008    Key Record Dates
Last Update Posted: April 8, 2015
Last Verified: April 2015