ProMRI ICD/CRT-D Post Approval Study

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.

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Key information

Conditions

Tachyarrhythmia Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

None

Treatment and study plan

Primary outcomes

Proportion of ICD/CRT-D subjects with a ≥ 5 second delay in post-MRI VF detection.

Time frame: Up to 5 years post-approval

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.
Proportion of LV pacing leads with a LV pacing threshold increase > 1V between pre-MRI and one-month post-MRI.

Time frame: Up to 5 years post-approval

Secondary outcomes

Workflow compliance following MR exposure

Time frame: Up to 5 years post-approval

Proportion of subjects with appropriate restoration of tachycardia detection and ICD therapy post-MRI.
Left ventricular sensing attenuation

Time frame: Up to 5 years post-approval

Proportion of subjects who experience left ventricular sensing amplitude attenuation >50% between pre-MRI and 30 days post-MRI.

Sponsors and collaborators

Lead sponsor

Biotronik, Inc.

Industry

Registry information

Important dates

Study start: 2016
Primary completion: 2019
Study completion: 2019
First posted: Oct 14, 2016
Registry last updated: Oct 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed