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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: August 21, 2014
Last verified: August 2014
  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: October 2014
Primary Completion Date: June 2014 (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
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 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: August 21, 2014
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
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014