Accent MRI Pacemaker and Tendril MRI Lead New Technology Assessment

NCT01258218 | Completed

• 1 other identifier: CR-10-027-EU-LV
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bradycardia

Study Arms (1)

Accent MRI Group

Device: Implantation of an Accent MRI device

Interventions

Implantation of an Accent MRI device DEVICE

Implantation of an Accent MRI device

Accent MRI Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Unknown Facility

Graz, Austria

Location

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2010
• First Posted: December 10, 2010
• Study Start: February 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: February 4, 2019

Record last verified: 2019-02

Locations

AU (1)