Safety and Efficacy Study of Tendril MRI™ Leads in Standard Bradycardia Pacing Indication
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
St. Jude Medical
First received: February 3, 2012
Last updated: July 26, 2013
Last verified: July 2013
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.
||Observational Model: Cohort
Time Perspective: Prospective
||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.
Primary Outcome Measures:
- Safety [ Time Frame: up to 12 months post-implant ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Primary Completion Date:
||October 2012 (Final data collection date for primary outcome measure)
Accent MRI System
Accent MRI system will be implanted = Accent MRI Pacemaker + Tendril MRI Leads
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
standard bradycardia indications
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01528150
St. Jude Medical
||Rob RW Breedveld, MD
||Medical Center Leeuwarden, the Netherlands
No publications provided
||St. Jude Medical
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 3, 2012
||July 26, 2013
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
United Kingdom: National Health Service
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 10, 2013