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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01576016
First received: April 4, 2012
Last updated: March 17, 2014
Last verified: March 2014
  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:


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:

  1. Have an approved indication per ACC/AHA/HRS guidelines for implantation of a pacemaker
  2. Will receive a new pacemaker and lead
  3. Be willing to undergo an elective MRI scan without sedation
  4. Be able to provide informed consent for study participation (legal guardian is NOT acceptable)
  5. Be willing and able to comply with the prescribed follow-up tests and schedule of evaluations
  6. 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:

  1. Are medically indicated for an MRI scan at the time of enrollment
  2. Have an existing pacemaker or ICD. A new pacemaker and lead is required for enrollment
  3. Have an existing active/inactive implanted medical device, e.g., neurostimulator, infusion pump, etc.
  4. Have a non-MRI compatible device or material implanted (e.g., intracranial aneurysm clip, non-MRI compatible devices or material, metals or alloys, etc.)
  5. Have a lead extender or adaptor
  6. Be unable to fit in MRI bore; will come into contact with the magnet façade inside the MRI bore.
  7. Have a prosthetic tricuspid heart valve
  8. Are currently participating in a clinical investigation that includes an active treatment arm
  9. Are allergic to dexamethasone sodium phosphate (DSP)
  10. Are pregnant or planning to become pregnant during the duration of the study
  11. Have a life expectancy of less than 12 months due to any condition
  12. Patients with exclusion criteria required by local law (e.g., age)
  13. Are unable to comply with the follow up schedule
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, Alabama
University Hospital of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Heart Center Research
Huntsville, Alabama, United States, 35801
United States, Arizona
Arizona Arrhythmia Research Center
Phoenix, Arizona, United States, 85016
United States, Arkansas
Arkansas Heart Hospital
Little Rock, Arkansas, United States, 72211
Baptist Health Medical Center
Little Rock, Arkansas, United States, 72205
Mercy Hospital Northwest Arkansas
Rogers, Arkansas, United States, 72758
United States, California
Central Cardiology
Bakersfield, California, United States, 93308
Raymond Schaerf, MD
Burbank, California, United States, 91505
John Muir Medical Center
Concord, California, United States, 94520
St. Jude Hospital
Fullerton, California, United States, 92835
Glendale Adventist Medical Center
Glendale, California, United States, 91206
Scripps Green Hospital
La Jolla, California, United States, 92037
Memorial Medical Center
Modesto, California, United States, 95355
Premier Cardiology, Inc / Hoag Hospital
Newport Beach, California, United States, 92629
Desert Cardiology Consultants
Rancho Mirage, California, United States, 92270
Mercy General Hospital
Sacramento, California, United States, 95819
Sutter Memorial Hospital
Sacramento, California, United States, 95819
United States, Colorado
Aurora Denver Cardiology Associates
Denver, Colorado, United States, 80012
South Denver Cardiology Associates PC
Littleton, Colorado, United States, 80120
Medical Center of the Rockies
Loveland, Colorado, United States, 80538
United States, Florida
Medical Specialists of the Palm Beaches
Atlantis, Florida, United States, 33462
Watson Clinic Center
Lakeland, Florida, United States, 33647
Florida Hospital Orlando
Orlando, Florida, United States, 32803
Orlando Health
Orlando, Florida, United States, 32806
Brevard Cardiovascular Research Associates
Rockledge, Florida, United States, 32955
Tallahassee Research Institute
Tallahassee, Florida, United States, 32308
University of South Florida, Cardiovascular Services
Tampa, Florida, United States, 33606
United States, Georgia
Athens Cardiology Group, PC
Athens, Georgia, United States, 30606
Atlanta Heart Specialist
Atlanta, Georgia, United States, 30041
United States, Illinois
Prairie Education and Research Cooperative
Springfield, Illinois, United States, 62701
United States, Kentucky
Central Baptist Hospital
Lexington, Kentucky, United States, 40503
United States, Louisiana
Ochsner Medical Center
New Orleans, Louisiana, United States, 70121
United States, Michigan
Spectrum Health
Grand Rapids, Michigan, United States, 49503
Thoracic Cardio Healthcare Foundation
Lansing, Michigan, United States, 48910
Providence Hospital
Southfield, Michigan, United States, 48075
United States, Minnesota
Minneapolis Heart Institute
Minneapolis, Minnesota, United States, 55407
United States, Missouri
St. Luke's Hospital
Kansas City, Missouri, United States, 64111
Missouri Baptist Medical Center
St. Louis, Missouri, United States, 63131
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, Nebraska
Alegent Creighton Health
Omaha, Nebraska, United States, 68124
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14450
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7075
Mid Carolina Cardiology
Charlotte, North Carolina, United States, 28204
Wake Forest University Medical Center Clinical Sciences
Winston-Salem, North Carolina, United States, 27615
United States, Ohio
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
The Ohio State University
Columbus, Ohio, United States, 43210
Columbus Cardiovascular Associates
Columbus, Ohio, United States, 43213
EMH Regional Medical Center
Elyria, Ohio, United States, 44035
St. Elizabeth Health Center
Youngstown, Ohio, United States, 44501
United States, Oklahoma
Integris Baptist Medical Center
Oklahoma City, Oklahoma, United States, 73112
Oklahoma Heart Institute at Utica
Tulsa, Oklahoma, United States, 73112
United States, Pennsylvania
Abington Medical Specialists
Abington, Pennsylvania, United States, 72758
Allegheny Singer Research Institute
Pittsburgh, Pennsylvania, United States, 15212
Donald Guthrie Foundation for Education and Research
Sayre, Pennsylvania, United States, 18840
York Hospital
York, Pennsylvania, United States, 17403
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29401
PMG Research of Charleston, LLC
Charleston, South Carolina, United States, 29406
United States, Texas
Austin Heart
Austin, Texas, United States, 78756
South Texas Cardiovascular Consultants
San Antonio, Texas, United States, 78201
Scott & White Memorial Hospital
Temple, Texas, United States, 76508
United States, Virginia
Martha Jefferson Hospital
Charlottesville, Virginia, United States, 22911
Virginia Cardiovascular Associates, PC
Manassas, Virginia, United States, 20109
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
United States, Washington
Kitsap Cardiology Consultants
Bremerton, Washington, United States, 98310
The Heart Institute at Virginia Mason
Seattle, Washington, United States, 98101
United States, Wisconsin
Aurora Medical Group
Milwaukee, Wisconsin, United States, 14450
Australia, South Australia
St. Andrews Hospital
Adelaide, South Australia, Australia, 5000
Belgium
Cliniques Universitaires Saint Luc
Brussels, B Cap R, Belgium, 1200
Finland
Kuopio University Hospital
Kuopio, East Finland, Finland, 70211
Netherlands
Diakonessenhuis Utrecht
Utrecht, Netherlands, 3582 KE
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 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by St. Jude Medical:
bradycardia
MRI scans

ClinicalTrials.gov processed this record on July 22, 2014