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Safety and Efficacy Study of Tendril MRI™ Leads in Standard Bradycardia Pacing Indication (TendrilMRI™)

This study has been completed.
Information provided by (Responsible Party):
St. Jude Medical Identifier:
First received: February 3, 2012
Last updated: July 19, 2016
Last verified: July 2016
The purpose of this observational study is the assessment (safety and efficacy) of the St. Jude Medical Tendril MRI™ leads. The Tendril MRI™ leads are a full part of the Accent MRI™ System, consisting of Tendril MRI™ leads and Accent MRI™ pacemaker. The subject population includes patients with a standard bradycardia pacing indication.


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.

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • 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.

Enrollment: 466
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

Detailed Description:

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
standard bradycardia indications

Inclusion Criteria:

  • Approved Class I or Class II indication per: European Society of Cardiology (ESC) guidelines for implantation of a dual chamber pacemaker or single chamber pacemaker, OR American College of Cardiology (ACC) / American Heart Association (AHA) / Heart Rhythm Society (HRS) guidelines for implantation of a dual chamber pacemaker or single chamber pacemaker
  • Require a new Accent MRI™ pacemaker and Tendril MRI™ lead (either initial implant or complete system change out with no abandoned devices).
  • Is ≥ 18 years of age.
  • Able to provide written informed consent prior to any investigational related procedure.
  • 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 implanted medical device (e.g., Implantable Cardioverter Defibrillator (ICD), neurostimulator, 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, plug or adaptor.
  • Have a prosthetic tricuspid heart valve.
  • Are currently participating in another investigational device or drug investigation.
  • Are allergic to Dexamethasone sodium phosphate (DSP).
  • Are pregnant or planning to become pregnant during the duration of the study.
  • Have a life expectancy of less than 12 months from Screening due to any life-threatening condition
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01528150

Sponsors and Collaborators
St. Jude Medical
Principal Investigator: Rob RW Breedveld, MD Medical Center Leeuwarden, the Netherlands
  More Information

Responsible Party: St. Jude Medical Identifier: NCT01528150     History of Changes
Other Study ID Numbers: CR-11-054-EU-LV 
Study First Received: February 3, 2012
Results First Received: December 2, 2015
Last Updated: July 19, 2016
Health Authority: Austria: Ethikkommission
Belgium: Ethics Committee
Finland: Ethics Committee
France: Committee for the Protection of Personnes
France: Conseil National de l'Ordre des Médecins
France: French Data Protection Authority
France: Institutional Ethical Committee
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Italy: Ethics Committee
Netherlands: Independent Ethics Committee
Netherlands: Medical Ethics Review Committee (METC)
Spain: Ethics Committee
Switzerland: Ethikkommission
United Kingdom: National Health Service
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes processed this record on October 21, 2016