ProMRI ICD/CRT-D Post Approval Study

Tachyarrhythmia Clinical Trial

Official title:

ProMRI ICD/CRT-D Post Approval Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02933619
• Other study ID #: ProMRI PAS
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Tachyarrhythmia
• Tachycardia

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