SureScan Post-Approval Study

Bradycardia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01299675
• Other study ID #: SureScan PAS
• Status: Completed
• First received: February 16, 2011
• Last updated: April 26, 2018
• Start date: February 8, 2011
• Est. completion date: October 2, 2017

Study information

• Verified date: April 2018
• Source: Medtronic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this Post-Approval Study (PAS) is to demonstrate the chronic performance of the SureScan pacing system when used in an MRI environment according to product labeling. This study is required by the Food and Drug Administration (FDA) as a condition of product approval.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2483
• Est. completion date: October 2, 2017
• Est. primary completion date: October 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

2. Subject is or intended to be implanted with a complete SureScan pacing system consisting of both a right atrial and ventricular 5086MRI Lead (used for pacing and sensing) and a SureScan device

3. Subject within 30 days of implant (maximum 50% of Chronic Performance Arm enrollment) or subject enrolled into Multiple MRI Scan Arm at the time of MRI scan indication

Exclusion Criteria:

1. Subject who is, or will be inaccessible for follow-up

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

3. Subject with exclusion criteria required by local law

Related Conditions & MeSH terms

• Bradycardia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI Related Complication Rate		5 years
Primary	Lead Related Complication Rate		5 years
Secondary	Assess change in pacing thresholds after multiple MRI scans		5 years
Secondary	Summarize MRI system and scan conditions		5 years
Secondary	Pacing system related events		5 years
Secondary	Characterize lead impedance		5 years