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OpenTrials
Completed

NCT Number: NCT01299675

SureScan Post-Approval Study

The purpose of this Post-Approval Study (PAS) is to demonstrate the chronic performance of the SureScan pacing system when used in an MRI environment according to product labeling. This study is required by the Food and Drug Administration (FDA) as a condition of product approval.

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Key information

Conditions

Bradycardia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Kingston, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
  • Subject is or intended to be implanted with a complete SureScan pacing system consisting of both a right atrial and ventricular 5086MRI Lead (used for pacing and sensing) and a SureScan device
  • Subject within 30 days of implant (maximum 50% of Chronic Performance Arm enrollment) or subject enrolled into Multiple MRI Scan Arm at the time of MRI scan indication

Exclusion criteria

  • Subject who is, or will be inaccessible for follow-up
  • Implant and follow-up data, including adverse device effects and system modifications at implant through the time of enrollment are unavailable
  • Subject with exclusion criteria required by local law

Treatment and study plan

Primary outcomes

  1. MRI Related Complication Rate

    Time frame: 5 years

  2. Lead Related Complication Rate

    Time frame: 5 years

Secondary outcomes

  1. Assess change in pacing thresholds after multiple MRI scans

    Time frame: 5 years

  2. Summarize MRI system and scan conditions

    Time frame: 5 years

  3. Pacing system related events

    Time frame: 5 years

  4. Characterize lead impedance

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Medtronic

Industry

Registry information

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Feb 18, 2011
Registry last updated
Apr 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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