REmote MOnitoring Transmission Evaluation of IPGs - Full Text View

Sponsored by:	Medtronic
Information provided by:	Medtronic
ClinicalTrials.gov Identifier:	NCT00631709

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:

To determine clinician perceived quality of care for CareLink remote follow-up.
To determine patient satisfaction with CareLink follow-up.
To estimate the time required to perform patient follow-up via CareLink remote transmissions.
To determine the percentage of regular CareLink follow-ups that do not require further in-clinic review of the patient.
To estimate potential patient cost avoidance for one year of follow up incorporating CareLink.
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 IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	REmote MOnitoring Transmission Evaluation of IPGs

Further study details as provided by Medtronic:

Estimated Enrollment:	120
Study Start Date:	March 2008
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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

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:	Medtronic of Canada Ltd ( Allison Rubino, Clinical Research Manager )
Study ID Numbers:	REMOTE-IPG 2008
Study First Received:	March 3, 2008
Last Updated:	March 10, 2009
ClinicalTrials.gov Identifier:	NCT00631709 History of Changes
Health Authority:	Canada: Ethics Review Committee; Canada: Health Canada

ClinicalTrials.gov processed this record on May 07, 2009