REmote MOnitoring Transmission Evaluation of IPGs

Pacemaker Clinical Trial

— REMOTE-IPG  

Official title:

REmote MOnitoring Transmission Evaluation of IPGs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00631709
• Other study ID #: REMOTE-IPG 2008
• Status: Completed
• Phase: Phase 4
• First received: March 3, 2008
• Last updated: April 24, 2018
• Start date: March 2008
• Est. completion date: February 2010

Study information

• Verified date: April 2018
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Pacemaker

Intervention

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

Locations

Country	Name	City	State
Canada	Kelowna General Hospital	Kelowna	British Columbia
Canada	Southlake Regional Hospital	Newmarket	Ontario
Canada	CHUQ, L'Hotel Dieu de Quebec	Quebec City	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Country where clinical trial is conducted

Canada,