3T MRI CIED Post-Approval Study

Cardiac Rhythm Disorder Clinical Trial

Official title:

Pacing Capture Threshold Change Following 3T MRI Scan of MR Conditional Cardiac Implantable Electronic Devices

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02969395
• Other study ID #: 3T
• Status: Completed
• Start date: April 2016
• Est. completion date: October 15, 2021

Study information

• Verified date: August 2022
• Source: Medtronic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study is to evaluate product performance of Magnetic Resonance (MR) Conditional Cardiac Implantable Electronic Devices (CIED) following 3 tesla (3T) MRI exposure. This will be achieved by evaluating the changes in pacing capture threshold (PCT) measurements following 3T MRI scan exposure. This study is required by FDA as a condition of approval of 3T MRI compatible labeling of applicable CIED systems. This study is conducted within Medtronic's post-market surveillance platform, the Product Surveillance Registry (PSR).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: October 15, 2021
• Est. primary completion date: October 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements

• Subject is intended to be implanted or is within 30 days post-implant of a qualifying Medtronic 3T MR Conditional CIED system

Exclusion Criteria:

• Subject who is, or will be inaccessible for follow-up at a study site

• Subject with exclusion criteria required by local law (Europe, Central Asia [ECA] only)

• Implant and follow-up data, including any adverse device effects and system modifications at implant through the time of enrollment are unavailable

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Rhythm Disorder

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  China,  Denmark,  France,  Germany,  Greece,  Hungary,  Italy,  Japan,  Korea, Republic of,  Malaysia,  Netherlands,  Portugal,  Serbia,  Slovakia,  Slovenia,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients implanted with an MR Conditional CIED System with a pre-MRI to post-MRI scan PCT measure change of >0.5 Volts following 3T MRI scan exposure.		Patients will be followed for approximately 5 years.