MedTrace Logo

Abbott Brady 3T MRI PMCF

NCT03786640 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3

Last updated 2022-04-14

No results posted yet for this study

Summary

The objective of this post-market, clinical follow up (PMCF) study, is to confirm the long-term safety of the Tendril STS and Isoflex leads, implanted with the Assurity MRI™ or Endurity MRI™ pacemakers, in patients undergoing a clinically indicated 3T MRI (3 Tesla Magnetic Resonance Imaging) scan.

Conditions

  • Syncope
  • Presyncope
  • Fatigue
  • Disorientation
  • Arrythmia
  • Bradycardia

Interventions

RADIATION

3T MRI scan

A clinically indicated 3T MRI scan will be performed per standard procedures for the radiology department. Cardiac monitoring during the MRI scan is recommended to include Pulse Oximetry and/or ECG.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-04
Primary Completion
2021-11-18
Completion
2021-12-18

Countries

  • Estonia
  • France
  • India
  • Italy
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03786640 on ClinicalTrials.gov