SureScan Post-Approval Study

April 26, 2018 updated by: Medtronic
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

2483

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada
    • Quebec
      • Trois-Rivieres, Quebec, Canada
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • Bakersfield, California, United States
      • Chula Vista, California, United States
      • East Palo Alto, California, United States
      • Fresno, California, United States
      • Glendale, California, United States
      • Long Beach, California, United States
      • Los Angeles, California, United States
      • Salinas, California, United States
      • Santa Rosa, California, United States
      • Torrance, California, United States
      • Van Nuys, California, United States
    • Colorado
      • Colorado Springs, Colorado, United States
    • Connecticut
      • New Haven, Connecticut, United States
    • Florida
      • Bradenton, Florida, United States
      • Clearwater, Florida, United States
      • Fort Lauderdale, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Illinois
      • Urbana, Illinois, United States
    • Indiana
      • Evansville, Indiana, United States
    • Iowa
      • West Des Moines, Iowa, United States
    • Kansas
      • Kansas City, Kansas, United States
    • Kentucky
      • Louisville, Kentucky, United States
    • Maryland
      • Salisbury, Maryland, United States
      • Takoma Park, Maryland, United States
    • Michigan
      • Marquette, Michigan, United States
      • Troy, Michigan, United States
    • Minnesota
      • Coon Rapids, Minnesota, United States
      • Robbinsdale, Minnesota, United States
      • Saint Louis Park, Minnesota, United States
      • Saint Paul, Minnesota, United States
    • Missouri
      • Kansas City, Missouri, United States
    • Nevada
      • Henderson, Nevada, United States
    • New Jersey
      • West Orange, New Jersey, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • New York
      • Huntington, New York, United States
      • New York, New York, United States
    • North Carolina
      • Durham, North Carolina, United States
      • Hickory, North Carolina, United States
      • Raleigh, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Akron, Ohio, United States
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
      • Columbus, Ohio, United States
      • Elyria, Ohio, United States
      • Toledo, Ohio, United States
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States
      • Erie, Pennsylvania, United States
      • Lancaster, Pennsylvania, United States
      • Wyomissing, Pennsylvania, United States
    • South Carolina
      • Florence, South Carolina, United States
    • Tennessee
      • Nashville, Tennessee, United States
    • Texas
      • Dallas, Texas, United States
      • Fort Sam Houston, Texas, United States
      • Fort Worth, Texas, United States
      • San Antonio, Texas, United States
    • Virginia
      • Falls Church, Virginia, United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients indicated for or implanted with a Medtronic SureScan Pacing System. All subjects must meet Inclusion criteria and none of the Exclusion criteria.

Description

Inclusion Criteria:

  1. Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
  2. 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
  3. 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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Chronic Performance
Subjects enrolled prior to or within 30 days post implant of SureScan pacing system. In office follow-up visits required every 6 months.
Multiple MRI Scan Characterization
Subject enrolled into study at the time of MRI Scan indication. Subject followed per clinic standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
MRI Related Complication Rate
Time Frame: 5 years
5 years
Lead Related Complication Rate
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Assess change in pacing thresholds after multiple MRI scans
Time Frame: 5 years
5 years
Summarize MRI system and scan conditions
Time Frame: 5 years
5 years
Pacing system related events
Time Frame: 5 years
5 years
Characterize lead impedance
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2011

Primary Completion (Actual)

October 2, 2017

Study Completion (Actual)

October 2, 2017

Study Registration Dates

First Submitted

February 16, 2011

First Submitted That Met QC Criteria

February 17, 2011

First Posted (Estimate)

February 18, 2011

Study Record Updates

Last Update Posted (Actual)

April 27, 2018

Last Update Submitted That Met QC Criteria

April 26, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SureScan PAS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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