NCT03786640

Abbott Brady 3T MRI PMCF

Long Term Follow-up of the Tendril STS and Isoflex Leads in Conjunction With the Assurity MRI™ and Endurity MRI™ Pacemakers Within the 3T MRI Environment (Brady 3T MRI PMCF)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This prospective, non-randomized, observational study will be conducted at 35 centers worldwide where the study devices have 3T MR Conditional labeling; up to 110 patients will be enrolled, and will satisfy the recent PMCF requirement to maintain the CE mark.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-10-04
• Primary completion: 2021-11-18
• Completion: 2021-12-18
• First posted: 2018-12-26
• Last updated: 2022-04-14

Locations

9 sites across 5 countries: Estonia, France, India, Italy, Netherlands