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NCT01299675

SureScan Post-Approval Study

Completed Last updated 27 April 2018
What this trial tests

trial in Bradycardia in 2,483 participants. Completed in 2 October 2017.

Timeline
8 February 2011
Primary endpoint
2 October 2017
2 October 2017

Quick facts

Lead sponsorMedtronic
StatusCompleted
Study typeOBSERVATIONAL
Enrollment2,483
Start date8 February 2011
Primary completion2 October 2017
Estimated completion2 October 2017
Sites61 locations across Canada, United States

Conditions studied

Sponsor

Medtronic — full company profile →

Who can join

Eligibility, any sex, with Bradycardia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Real-World Evaluation of Magnetic Resonance Imaging in Patients With a Magnetic Resonance Imaging Conditional Pacemaker System: Results of 4-Year Prospective Follow-Up in 2,629 Patients.
    Williamson BD, Gohn DC, Ramza BM, Singh B, et al · · 2017 · cited 19× · PMID 29759618 · DOI 10.1016/j.jacep.2017.05.011

Verify or expand the search:

Other recruiting trials for Bradycardia

Currently open trials in the same condition.

Other Medtronic trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01299675.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing