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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01528150
First received: February 3, 2012
Last updated: July 26, 2013
Last verified: July 2013
  Purpose

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.


Condition
Bradycardia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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:
  • Safety [ Time Frame: up to 12 months post-implant ] [ Designated as safety issue: Yes ]
    Complications


Estimated Enrollment: 456
Study Start Date: February 2012
Estimated Study Completion Date: September 2014
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Accent MRI System
Accent MRI system will be implanted = Accent MRI Pacemaker + Tendril MRI Leads

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

standard bradycardia indications

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01528150

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

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01528150     History of Changes
Other Study ID Numbers: CR-11-054-EU-LV
Study First Received: February 3, 2012
Last Updated: July 26, 2013
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

Additional relevant MeSH terms:
Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014