Accent MRI Pacemaker and Tendril MRI Lead New Technology Assessment

The intent of this study is to evaluate the performance of the implanted Accent MRI TM system in a clinical setting and optionally in the MRI environment. This system includes the St. Jude Medical Tendril MRI™ lead and SJM Accent MRITM DR pacemaker. Also the MRI Activator™ will be evaluated in this study. The MRI Activator is a handheld device that allows the user to enable and disable MRI Settings as well as check the status of MRI Settings in the pacemaker. The patient population under study includes patients with a standard bradycardia pacing indication.

Study Overview

• Status: Completed
• Conditions: Bradycardia
• Intervention / Treatment: Device: Implantation of an Accent MRI device

• Study Type: Observational
• Enrollment (Actual): 78

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with approved Class I or Class II indication per ESC guidelines for implantation of a dual chamber pacemaker or single chamber pacemaker.

Description

Inclusion Criteria:

• Approved Class I or Class II indication per ESC guidelines for implantation of a dual chamber pacemaker or single chamber pacemaker.
• Receiving a new Accent MRITM pacemaker and Tendril MRI™ lead (either initial implant or complete system change out with no abandoned devices).
• Ability to provide informed consent for study participation.
• Is willing and able to comply with the prescribed follow-up tests and schedule of evaluations.

Exclusion Criteria:

• Have an existing pacemaker or ICD (abandoned devices and/or leads are not allowed. A new pacemaker and lead or complete system change out is required for enrollment).
• Have an existing active/inactive implanted medical device (e. g., Neurostimulator, infusion pump, etc.).
• Have a non-MRI compatible device or material implant (e.g., intracranial aneurysm clip, non-MRI compatible devices or material, metals or alloys, etc.).
• Have a lead extender or adaptor.
• Have a mechanical, prosthetic or bioprosthetic tricuspid heart valve.
• Have an abdominal diameter (approximately > 60cm) which results in contact with the magnet façade.
• Are currently participating in a study that includes an active treatment arm.
• Are pregnant or planning to become pregnant during the duration of the study.
• Have a life expectancy of less than 6 months due to any condition.
• Are less than 18 years of age.
• Are unable to comply with the follow up schedule.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Accent MRI Group	Device: Implantation of an Accent MRI device; Implantation of an Accent MRI device

Collaborators and Investigators

• Sponsor: Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (ACTUAL): November 1, 2011
• Study Completion (ACTUAL): November 1, 2011

Study Registration Dates

• First Submitted: December 9, 2010
• First Submitted That Met QC Criteria: December 9, 2010
• First Posted (ESTIMATE): December 10, 2010

Study Record Updates

• Last Update Posted (ACTUAL): February 4, 2019
• Last Update Submitted That Met QC Criteria: February 1, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Bradycardia
• Other Study ID Numbers: CR-10-027-EU-LV