Ignite Creation Date:
2025-12-24 @ 6:27 PM
Ignite Modification Date:
2025-12-28 @ 12:41 PM
Study NCT ID:
NCT03012568
Status:
COMPLETED
Last Update Posted:
2019-08-05
First Post:
2017-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study to Confirm MRI Safety and Effectiveness Using St. Jude Medical (SJM) Cardiac Rhythm Management Systems
Sponsor:
Abbott Medical Devices
Organization:
Study Overview
Official Title:
ASSURE MRI Study - Clinical Study to Confirm MRI Safety and Effectiveness Using St. Jude Medical (SJM) Cardiac Rhythm Management Systems
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ASSUREMRI
Brief Summary:
This is a clinical investigational plan (CIP) for the "Clinical Study to Confirm MRI Safety and Effectiveness Using SJM Cardiac Rhythm Management Systems (ASSURE MRI)". This study intends to enroll patients who meet standard bradycardia or tachycardia indications and have already been implanted with one of the SJM device/lead combinations listed in this protocol. The objective of this study is to confirm the safety and effectiveness of each of the four SJM device/lead combinations in an MRI environment. This clinical investigation is sponsored by St. Jude Medical.
Detailed Description:
This is a prospective, multi-center clinical study designed to confirm the safety and effectiveness of St. Jude Medical low voltage pacemakers, high voltage dual chamber Implantable Cardioverter-Defibrillators (ICD), and Cardiac Resynchronization Therapy Defibrillators (CRT-D) with various leads in an MRI environment.
The study will enroll subjects across multiple geographies and sites. Sites in geographies where MRI labelling is not yet approved may also be included after appropriate IRB/EC and local regulatory approvals, as applicable, are obtained. A prospective, multi-center study design is chosen for generalizability of study results.
The clinical study will be conducted in approximately 40 centers worldwide. Approximately 88 subjects total (with a minimum 22 subjects for each of the four device/lead combinations) will be enrolled in this study.
Enrollment in the study is expected to take approximately 6-8 months. Subjects will be followed for 1 month following the MRI scan. The total study duration of the study is expected to be 10 months, depending on the rate of enrollment.
The study will enroll subjects across multiple geographies and sites. Sites in geographies where MRI labelling is not yet approved may also be included after appropriate IRB/EC and local regulatory approvals, as applicable, are obtained. A prospective, multi-center study design is chosen for generalizability of study results.
The clinical study will be conducted in approximately 40 centers worldwide. Approximately 88 subjects total (with a minimum 22 subjects for each of the four device/lead combinations) will be enrolled in this study.
Enrollment in the study is expected to take approximately 6-8 months. Subjects will be followed for 1 month following the MRI scan. The total study duration of the study is expected to be 10 months, depending on the rate of enrollment.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: