ProMRI ICD/CRT-D Post Approval Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02933619

Enrollment

24249

Registered

2016-10-14

Start date

2016-08-31

Completion date

2019-04-30

Last updated

2019-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tachyarrhythmia

Brief 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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Workflow compliance following MR exposure	Up to 5 years post-approval	Proportion of subjects with appropriate restoration of tachycardia detection and ICD therapy post-MRI.
Left ventricular sensing attenuation	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.

Outcome results