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REmote MOnitoring Transmission Evaluation of IPGs (REMOTE-IPG)

This study has been completed.
Sponsor:
Information provided by:
Medtronic
ClinicalTrials.gov Identifier:
NCT00631709
First received: March 3, 2008
Last updated: December 21, 2010
Last verified: December 2010
  Purpose

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 Intervention Phase
Pacemaker
Other: CareLink Remote Monitoring
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: REmote MOnitoring Transmission Evaluation of IPGs

Further study details as provided by Medtronic:

Enrollment: 120
Study Start Date: March 2008
Study Completion Date: February 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Pacemaker Patients
Other: CareLink Remote Monitoring
Substitution of CareLink Remote Monitoring of Pacemakers for in-clinic pacemaker follow-up visits

  Eligibility

Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Allison Rubino, Clinical Research Manager, Medtronic of Canada Ltd
ClinicalTrials.gov Identifier: NCT00631709     History of Changes
Other Study ID Numbers: REMOTE-IPG 2008
Study First Received: March 3, 2008
Last Updated: December 21, 2010
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

ClinicalTrials.gov processed this record on November 27, 2014