Safety and Efficacy Study of Tendril MRI™ Leads in Standard Bradycardia Pacing Indication (TendrilMRI™)
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration:||12 Months|
|Official Title:||Clinical Investigation to Assess the Safety and Efficacy of the Tendril MRI™ Leads, as a Part of the Accent MRI™ System, in Patients With Standard Bradycardia Pacing Indication.|
- Freedom From RA and RV Lead-related Complications [ Time Frame: up to 12 months post-implant ] [ Designated as safety issue: Yes ]Safety of the Accent MRI™ system with the Tendril MRI™ lead will be evaluated in terms of freedom from Right Atrial (RA) and Right Ventricular (RV) lead-related complications for the acute (implant to 2 month visit) and chronic (2 month visit through the 12 month visit) timeframes.
|Study Start Date:||February 2012|
|Study Completion Date:||March 2015|
|Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Accent MRI System
Accent MRI system will be implanted = Accent MRI Pacemaker + Tendril MRI Leads
Magnetic resonance imaging (MRI) is a diagnostic method to view high quality two and three dimensional images of the body. However, magnetic resonance imaging systems generate three electromagnetic fields that are used to produce an image. These include a static magnetic field, a time varying gradient magnetic field, and a radiofrequency field. All three of these fields interact with implanted devices and could create hazards for the device, the patient, or both. Due to these issues, currently marketed pacemaker systems may be contraindicated for use in an MRI environment.
St. Jude Medical has developed a system, the Accent MRI™ system, comprised of the Accent MRI™ device and the Tendril MRI™ lead, and an investigational MRI Activator™, designed to mitigate such interactions.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01528150
|Principal Investigator:||Rob RW Breedveld, MD||Medical Center Leeuwarden, the Netherlands|