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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03012568




Registration number
NCT03012568
Ethics application status
Date submitted
5/01/2017
Date registered
6/01/2017
Date last updated
5/08/2019

Titles & IDs
Public title
Clinical Study to Confirm MRI Safety and Effectiveness Using St. Jude Medical (SJM) Cardiac Rhythm Management Systems
Scientific title
ASSURE MRI Study - Clinical Study to Confirm MRI Safety and Effectiveness Using St. Jude Medical (SJM) Cardiac Rhythm Management Systems
Secondary ID [1] 0 0
SJM-CIP-10137
Universal Trial Number (UTN)
Trial acronym
ASSUREMRI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bradycardia 0 0
Tachycardia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - SJM Implantable cardiac devices

Treatment: Devices: SJM Implantable cardiac devices
SJM implantable devices undergoing MRI scan
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety Endpoint: Freedom from MRI scan-related complications
Timepoint [1] 0 0
One month following the MRI scan.

Eligibility
Key inclusion criteria
* Are implanted with one of the following SJM device/lead combinations evaluated in this study for at least 60 days (can include patients with an eligible SJM lead for = 60 days OR patients with a new eligible SJM pacemaker, Implantable Cardioverter-Defibrillators (ICD), or Cardiac Resynchronization Therapy Defibrillators (CRT-D) device and eligible SJM lead implanted for at least 60 days:

1. Accent MRI™, Assurity MRI™, Endurity MRI™, or Endurity pacemaker with Tendril™ STS Model 2088 lead
2. Accent MRI™, Assurity MRI™, Endurity MRI™, or Endurity pacemaker with IsoFlex™ Optim (Model 1944 or 1948) lead
3. Ellipse™ VR/DR or Fortify Assura VR/DR ICD with Tendril™ STS (Model 2088) or Tendril MRI™ and Durata™ or Optisure™ leads
4. Quadra Assura™ CRT-D with Tendril™ STS (Model 2088), Durata™ or Optisure™, and Quartet™ Quadripolar leads
* Are implanted with an eligible SJM pacemaker, ICD, or CRT-D device pectorally
* Be willing to undergo an elective MRI scan without sedation. Note: Antianxiety agents (e.g. minor tranquilizers, etc.) may be used as long as the subject can communicate with site personnel during the MRI scan
* Be able to provide informed consent for study participation (legal guardian is NOT acceptable)
* Be willing and able to comply with the prescribed follow-up tests and schedule of evaluations
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have another existing active implanted medical device, e.g., neurostimulator, infusion pump, etc. that has MR labeling that will not allow the MRI scans per this protocol to be completed.
* Have other non-MRI compatible device or material implanted

* NOTE: MRI compatible knee replacements, hip replacements, stents, etc. may be included as long as the labeling of these devices allow MRI scans conducted per this protocol
* NOTE: MRI compatible mechanical, prosthetic, and bioprosthetic heart valves may be included as long as the labeling of these devices allow for MRI scans conducted per this protocol
* NOTE: Non-removable dental implants may be included
* Have a lead extender, adaptor, or capped/abandoned lead
* Be unable to fit in MRI bore, i.e., subject will come into contact with the magnet façade inside the MRI bore.
* Are currently participating in a clinical investigation that includes an active treatment arm
* Are pregnant or planning to become pregnant during the duration of the study
* Have a life expectancy of less than 3 months due to any condition
* Meet exclusion criteria per local law (e.g. age)

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/11/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/03/2018
Sample size
Target
Accrual to date
Final
119
Recruitment in Australia
Recruitment state(s)
QLD,WA
Recruitment hospital [1] 0 0
Heart Care Partners - Wesley Hospital - Auchenflower
Recruitment hospital [2] 0 0
Heart Care Western Australia - Perth
Recruitment postcode(s) [1] 0 0
4066 - Auchenflower
Recruitment postcode(s) [2] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
India
State/province [1] 0 0
Andhra Pradesh

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT03012568
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Grant Kim
Address 0 0
Abbott Medical Devices
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03012568