Safety and Efficacy of the Accent Magnetic Resonance Imaging™ (MRI) Pacemaker and Tendril MRI™ Lead - Full Text View

Purpose

The MRI Study is a prospective, multi-center, clinical study designed to evaluate the safety and efficacy of the Accent MRI System in a patient population indicated for implant of a pacemaker within and outside of the MRI environment.

Condition	Intervention
Adverse Effect of MRI on an Implanted Pacemaker Lead Adverse Effect of MRI on an Implanted Pacemaker	Device: Accent MRI system

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Accent Magnetic Resonance Imaging Pacemaker and Tendril Magnetic Resonance Imaging™ Lead Investigational Device Exemption Study

Resource links provided by NLM:

MedlinePlus related topics: MRI Scans Nuclear Scans

U.S. FDA Resources

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:

Freedom from right atrial (RA) lead-related complications in the acute period [ Time Frame: Implant through 2 months ] [ Designated as safety issue: Yes ]
Proportion of patients who do not have RA lead-related complications from implant through the 2 month study visit
Freedom from right ventricular (RV) lead-related complications in the acute time period [ Time Frame: Implant through 2 months ] [ Designated as safety issue: Yes ]
Proportion of patients who do not have RV lead-related complications from implant through the 2 month study visit
Freedom from RA related complications in the chronic period [ Time Frame: 2 months thru 12 months ] [ Designated as safety issue: Yes ]
Proportion of patients who do not have RA lead-related complications from the 2 month through the 12 month study visit
Freedom from right ventricular lead related complications in the chronic period [ Time Frame: 2 months thru 12 months ] [ Designated as safety issue: Yes ]
Proportion of patients who do not have RV lead-related complications from the 2 month through the 12 month study visit
Freedom from MRI scan-related complications [ Time Frame: MRI Scan visit and 1 month after MRI scan visit ] [ Designated as safety issue: Yes ]
Proportion of patients who do not have MRI-related complications from the MRI scan visit to the 1 month post MRI scan visit
Change in atrial capture thresholds (before and after the MRI Scan) [ Time Frame: MRI Scan visit and 1 month after MRI scan visit ] [ Designated as safety issue: No ]
Difference in the proportion of patients with an increase in RA capture thresholds at 0.5 ms between those randomized to receive an MRI scan versus those not receiving an MRI scan.
Change in ventricular capture thresholds (before and after the MRI scan) [ Time Frame: MRI Scan visit and 1 month after MRI scan visit ] [ Designated as safety issue: No ]
Difference in the proportion of patients with an increase in RV capture thresholds at 0.5 ms between those randomized to receive an MRI scan versus those not receiving an MRI scan.
Change in atrial sensing threshold (before and after the MRI scan) [ Time Frame: MRI Scan visit and 1 month after MRI scan visit ] [ Designated as safety issue: No ]
Difference in the proportion of patients with an increase in RA sensing threshold between those randomized to receive an MRI scan versus those not receiving an MRI scan.
Change in ventricular sensing threshold (before and after the MRI scan) [ Time Frame: MRI Scan visit and 1 month after the MRI Scan visit ] [ Designated as safety issue: No ]
Difference in the proportion of patients with an increase in RV sensing threshold between those randomized to receive an MRI scan versus those not receiving an MRI scan.

Secondary Outcome Measures:

Freedom from system-related complications [ Time Frame: Implant through 12 months ] [ Designated as safety issue: Yes ]
Proportion of patients who do not have system-related complications from implant through the 12 month study visit
Atrial capture threshold at the MRI visit [ Time Frame: MRI Scan visit (approx 3 months post implant) ] [ Designated as safety issue: No ]
Proportion of patients with RA capture threshold ≤2.0V at the MRI visit
Ventricular capture threshold at the MRI visit [ Time Frame: MRI Scan visit (approx 3 months post implant) ] [ Designated as safety issue: No ]
Proportion of patients with RV capture threshold ≤2.0V at the MRI visit

Estimated Enrollment:	800
Study Start Date:	March 2012
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	March 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Accent MRI system MRI Scan Group Patient implanted with an Accent MRI system will receive an MRI scan	Device: Accent MRI system Patients implanted with an Accent MRI system will receive 30 minutes of magnetic scan imaging Other Names: Accent MRI pacemaker Tendril MRI lead
Placebo Comparator: Accent MRI System MRI Control Group Patient implanted with an Accent MRI system will not receive an MRI scan	Device: Accent MRI system Patients implanted with an Accent MRI system will wait for one hour without receiving an MRI scan Other Names: Accent MRI pacemaker Tendril MRI lead

Detailed Description:

The safety and efficacy of the Accent MRI pacemaker and Tendril MRI lead will be evaluated as described below:

Lead Safety Safety of the Tendril MRI™ lead will be evaluated in terms of freedom from RA and RV lead-related complications at implant to 2 months, and at the 2 through the 12 month visit.

MRI Safety The safety of the Accent MRI system will be evaluated in terms of freedom from MRI scan related complications in the month following the MRI scan.

Lead Efficacy Efficacy of the Tendril MRI™ lead will be evaluated in terms of the change in atrial and ventricular capture and sensing thresholds before and after the MRI scan.

Secondary Endpoints Safety Safety of the Accent MRITM system will be evaluated in terms of freedom from system-related complications through the 12 month visit.

Efficacy Efficacy of the Tendril MRI™ lead will be evaluated in terms of the atrial and ventricular capture thresholds at the MRI Visit.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Eligible patients will meet all of the following:

Have an approved indication per ACC/AHA/HRS guidelines for implantation of a pacemaker
Will receive a new pacemaker and lead
Be willing to undergo an elective MRI scan without sedation
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
Is not contraindicated for an MRI scan (per the pre-MRI safety screening form)

Exclusion Criteria:

Patients will be excluded if they meet any of the following:

Are medically indicated for an MRI scan at the time of enrollment
Have an existing pacemaker or ICD. A new pacemaker and lead is required for enrollment
Have an existing active/inactive implanted medical device, e.g., neurostimulator, infusion pump, etc.
Have a non-MRI compatible device or material implanted (e.g., intracranial aneurysm clip, non-MRI compatible devices or material, metals or alloys, etc.)
Have a lead extender or adaptor
Be unable to fit in MRI bore; will come into contact with the magnet façade inside the MRI bore.
Have a prosthetic tricuspid heart valve
Are currently participating in a clinical investigation that includes an active treatment arm
Are allergic to dexamethasone sodium phosphate (DSP)
Are pregnant or planning to become pregnant during the duration of the study
Have a life expectancy of less than 12 months due to any condition
Patients with exclusion criteria required by local law (e.g., age)
Are unable to comply with the follow up schedule

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01576016

Contacts

Contact: Ashish Oza	1-800-423-5611 ext 3648	aoza@sjm.com
Contact: Kieu Ha	800-733-3455 ext 6269

Show 70 Study Locations

Sponsors and Collaborators

St. Jude Medical

Investigators

Study Director:

Ashish Oza

St. Jude Medical

More Information

No publications provided

Responsible Party:	St. Jude Medical
ClinicalTrials.gov Identifier:	NCT01576016 History of Changes
Other Study ID Numbers:	60028820
Study First Received:	April 4, 2012
Last Updated:	March 19, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by St. Jude Medical:

bradycardia
MRI scans

ClinicalTrials.gov processed this record on May 22, 2013