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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02933619
Other study ID # ProMRI PAS
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 2016
Est. completion date April 2019

Study information

Verified date October 2019
Source Biotronik, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Following product approval, confirmation of appropriate VF episode detection after MRI exposure of the ProMRI ICD/CRT-D systems and to evaluate left ventricular pacing threshold changes post-MRI.


Recruitment information / eligibility

Status Completed
Enrollment 24249
Est. completion date April 2019
Est. primary completion date April 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- ProMRI ICD/CRT-D system enabled with BIOTRONIK Home Monitoring.

Exclusion Criteria:

- None

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Biotronik, Inc.

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of ICD/CRT-D subjects with a = 5 second delay in post-MRI VF detection. Primary objectives will be analyzed once 25 subjects implanted with the ProMRI ICD system have been identified with a documented true VF episode post-MRI. Up to 5 years post-approval
Primary Proportion of LV pacing leads with a LV pacing threshold increase > 1V between pre-MRI and one-month post-MRI. Up to 5 years post-approval
Secondary Workflow compliance following MR exposure Proportion of subjects with appropriate restoration of tachycardia detection and ICD therapy post-MRI. Up to 5 years post-approval
Secondary Left ventricular sensing attenuation Proportion of subjects who experience left ventricular sensing amplitude attenuation >50% between pre-MRI and 30 days post-MRI. Up to 5 years post-approval
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