Safety and Efficacy of the Accent Magnetic Resonance Imaging™ (MRI) Pacemaker and Tendril MRI™ Lead
This study is currently recruiting participants.
Verified March 2013 by St. Jude Medical
Sponsor:
St. Jude Medical
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01576016
First received: April 4, 2012
Last updated: March 19, 2013
Last verified: March 2013
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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:
|
|
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:
|
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
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Contacts
| Contact: Ashish Oza | 1-800-423-5611 ext 3648 | aoza@sjm.com |
| Contact: Kieu Ha | 800-733-3455 ext 6269 |
Hide Study LocationsLocations
| United States, Alabama | |
| University Hospital of Alabama at Birmingham | Recruiting |
| Birmingham, Alabama, United States, 35233 | |
| Contact: Harish Doppalapudi, MD 205-934-3614 | |
| Principal Investigator: Harish Doppalapudi, MD | |
| Heart Center Research | Recruiting |
| Huntsville, Alabama, United States, 35801 | |
| Contact: Paul Tabereaux | |
| United States, Arizona | |
| Arizona Arrhythmia Research Center | Recruiting |
| Phoenix, Arizona, United States, 85016 | |
| Principal Investigator: Vijendra Swarup, MD | |
| United States, Arkansas | |
| Arkansas Heart Hospital | Recruiting |
| Little Rock, Arkansas, United States, 72211 | |
| Contact: Wilson Wong | |
| Principal Investigator: Wilson Wong, MD | |
| Baptist Health Medical Center | Recruiting |
| Little Rock, Arkansas, United States, 72205 | |
| Contact: Stephen Greer | |
| Principal Investigator: Stephen Greer | |
| Mercy Hospital Northwest Arkansas | Recruiting |
| Rogers, Arkansas, United States, 72758 | |
| Contact: Amr El-Shafei, MD | |
| United States, California | |
| Central Cardiology | Recruiting |
| Bakersfield, California, United States, 93308 | |
| Contact: Jared Salvo | |
| Raymond Schaerf, MD | Recruiting |
| Burbank, California, United States, 91505 | |
| Contact: Raymond Schaerf | |
| Principal Investigator: Raymond Schaerf, MD | |
| John Muir Medical Center | Recruiting |
| Concord, California, United States, 94520 | |
| Contact: Perkin Shiu, MD | |
| St. Jude Hospital | Recruiting |
| Fullerton, California, United States, 92835 | |
| Contact: Rahul Doshi | |
| Glendale Adventist Medical Center | Recruiting |
| Glendale, California, United States, 91206 | |
| Contact: John McKenzie, MD | |
| Scripps Green Hospital | Recruiting |
| La Jolla, California, United States, 92037 | |
| Contact: Thomas Ahern | |
| Memorial Medical Center | Active, not recruiting |
| Modesto, California, United States, 95355 | |
| Premier Cardiology, Inc / Hoag Hospital | Active, not recruiting |
| Newport Beach, California, United States, 92629 | |
| Desert Cardiology Consultants | Recruiting |
| Rancho Mirage, California, United States, 92270 | |
| Contact: Andrew Rubin | |
| Mercy General Hospital | Recruiting |
| Sacramento, California, United States, 95819 | |
| Contact: Peter Jurisich | |
| Sutter Memorial Hospital | Recruiting |
| Sacramento, California, United States, 95819 | |
| Contact: Subramaniam Krishnan | |
| United States, Colorado | |
| Aurora Denver Cardiology Associates | Recruiting |
| Denver, Colorado, United States, 80012 | |
| Contact: Nelson Prager | |
| South Denver Cardiology Associates PC | Active, not recruiting |
| Littleton, Colorado, United States, 80120 | |
| Medical Center of the Rockies | Active, not recruiting |
| Loveland, Colorado, United States, 80538 | |
| United States, Florida | |
| Medical Specialists of the Palm Beaches | Recruiting |
| Atlantis, Florida, United States, 33462 | |
| Contact: Alex Chernobelsky | |
| Watson Clinic Center | Recruiting |
| Lakeland, Florida, United States, 33647 | |
| Contact: Kevin Browne | |
| Florida Hospital Orlando | Recruiting |
| Orlando, Florida, United States, 32803 | |
| Contact: George Monir | |
| Orlando Health | Recruiting |
| Orlando, Florida, United States, 32806 | |
| Contact: Peter Taylor | |
| Brevard Cardiovascular Research Associates | Active, not recruiting |
| Rockledge, Florida, United States, 32955 | |
| Tallahassee Research Institute | Recruiting |
| Tallahassee, Florida, United States, 32308 | |
| Principal Investigator: Farhat S Khairallah, MD | |
| University of South Florida, Cardiovascular Services | Recruiting |
| Tampa, Florida, United States, 33606 | |
| Contact: Herweg Herweg, MD | |
| United States, Georgia | |
| Athens Cardiology Group, PC | Recruiting |
| Athens, Georgia, United States, 30606 | |
| Contact: David Woodard | |
| Atlanta Heart Specialist | Recruiting |
| Atlanta, Georgia, United States, 30041 | |
| Contact: Narendra Singh | |
| United States, Illinois | |
| Prairie Education and Research Cooperative | Recruiting |
| Springfield, Illinois, United States, 62701 | |
| Contact: Ziad Issa, MD | |
| United States, Kentucky | |
| Central Baptist Hospital | Recruiting |
| Lexington, Kentucky, United States, 40503 | |
| Contact: Gery Tomassoni, MD | |
| Principal Investigator: Gery Tomassoni, MD | |
| United States, Louisiana | |
| Ochsner Medical Center | Recruiting |
| New Orleans, Louisiana, United States, 70121 | |
| Contact: Daniel Morin | |
| United States, Michigan | |
| Spectrum Health | Recruiting |
| Grand Rapids, Michigan, United States, 49503 | |
| Contact: Andre Gauri | |
| Thoracic Cardio Healthcare Foundation | Recruiting |
| Lansing, Michigan, United States, 48910 | |
| Contact: Ranjan Thakur | |
| Providence Hospital | Recruiting |
| Southfield, Michigan, United States, 48075 | |
| Contact: Christian Machado, MD | |
| United States, Minnesota | |
| Minneapolis Heart Institute | Recruiting |
| Minneapolis, Minnesota, United States, 55407 | |
| Contact: Chuen Tang | |
| United States, Missouri | |
| St. Luke's Hospital | Recruiting |
| Kansas City, Missouri, United States, 64111 | |
| Contact: Brian Ramza | |
| Missouri Baptist Medical Center | Recruiting |
| St. Louis, Missouri, United States, 63131 | |
| Contact: Karthik Ramaswamy | |
| Washington University School of Medicine | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Contact: Mitchell Faddis | |
| United States, Nebraska | |
| Alegent Creighton Health | Recruiting |
| Omaha, Nebraska, United States, 68124 | |
| Contact: Kent Gleed, MD | |
| United States, New York | |
| University of Rochester Medical Center | Active, not recruiting |
| Rochester, New York, United States, 14450 | |
| United States, North Carolina | |
| University of North Carolina at Chapel Hill | Recruiting |
| Chapel Hill, North Carolina, United States, 27599-7075 | |
| Contact: Jennifer Schwartz, MD | |
| Mid Carolina Cardiology | Recruiting |
| Charlotte, North Carolina, United States, 28204 | |
| Contact: Russ Bailey, MD | |
| Wake Forest University Medical Center Clinical Sciences | Recruiting |
| Winston-Salem, North Carolina, United States, 27615 | |
| Contact: Rick Henderson, MD | |
| United States, Ohio | |
| The Cleveland Clinic Foundation | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Daniel Cantillon, MD | |
| The Ohio State University | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: Mahmoud Houmsse | |
| Columbus Cardiovascular Associates | Recruiting |
| Columbus, Ohio, United States, 43213 | |
| Contact: Shailesh Patel, MD | |
| EMH Regional Medical Center | Recruiting |
| Elyria, Ohio, United States, 44035 | |
| Contact: Kara Quan | |
| St. Elizabeth Health Center | Recruiting |
| Youngstown, Ohio, United States, 44501 | |
| Contact: David Hoffman, MD | |
| United States, Oklahoma | |
| Integris Baptist Medical Center | Recruiting |
| Oklahoma City, Oklahoma, United States, 73112 | |
| Contact: Richard Lane, MD | |
| Oklahoma Heart Institute at Utica | Recruiting |
| Tulsa, Oklahoma, United States, 73112 | |
| Contact: David Sandler | |
| United States, Pennsylvania | |
| Abington Medical Specialists | Recruiting |
| Abington, Pennsylvania, United States, 72758 | |
| Contact: Charles Gottlieb, MD | |
| Allegheny Singer Research Institute | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15212 | |
| Contact: Robert Biederman | |
| Donald Guthrie Foundation for Education and Research | Recruiting |
| Sayre, Pennsylvania, United States, 18840 | |
| Contact: Pramod Deshmukh, MD | |
| York Hospital | Recruiting |
| York, Pennsylvania, United States, 17403 | |
| Contact: Lyle Siddoway | |
| United States, South Carolina | |
| Medical University of South Carolina | Recruiting |
| Charleston, South Carolina, United States, 29401 | |
| Contact: Robert B. Leman, MD 843-792-7525 lemanrb@musc.edu | |
| Principal Investigator: Robert B. Leman, MD | |
| PMG Research of Charleston, LLC | Recruiting |
| Charleston, South Carolina, United States, 29406 | |
| Contact: Lars Runquist, MD | |
| United States, Texas | |
| Austin Heart | Recruiting |
| Austin, Texas, United States, 78756 | |
| Contact: David Kessler | |
| South Texas Cardiovascular Consultants | Recruiting |
| San Antonio, Texas, United States, 78201 | |
| Contact: Javier Roman Gonzalez | |
| Scott & White Memorial Hospital | Recruiting |
| Temple, Texas, United States, 76508 | |
| Contact: Taresh Taneja, MD | |
| United States, Virginia | |
| Martha Jefferson Hospital | Recruiting |
| Charlottesville, Virginia, United States, 22911 | |
| Contact: John Zakaib | |
| Virginia Cardiovascular Associates, PC | Recruiting |
| Manassas, Virginia, United States, 20109 | |
| Contact: Chirag Sandesara, MD | |
| Sentara Norfolk General Hospital | Recruiting |
| Norfolk, Virginia, United States, 23507 | |
| Contact: Venkat Iyer | |
| United States, Washington | |
| Kitsap Cardiology Consultants | Recruiting |
| Bremerton, Washington, United States, 98310 | |
| Contact: Nathan Segerson | |
| The Heart Institute at Virginia Mason | Recruiting |
| Seattle, Washington, United States, 98101 | |
| Contact: Suzanne Vogt 206-342-6514 | |
| Principal Investigator: Christopher Fellows, MD | |
| United States, Wisconsin | |
| Aurora Medical Group | Recruiting |
| Milwaukee, Wisconsin, United States, 14450 | |
| Contact: Eyman Mortada | |
| Australia, South Australia | |
| St. Andrews Hospital | Recruiting |
| Adelaide, South Australia, Australia, 5000 | |
| Principal Investigator: Glenn Young | |
| Belgium | |
| Cliniques Universitaires Saint Luc | Recruiting |
| Brussels, B Cap R, Belgium, 1200 | |
| Contact: Jean-Benoit Le Polain de Waroux, MD | |
| Finland | |
| Kuopio University Hospital | Recruiting |
| Kuopio, East Finland, Finland, 70211 | |
| Contact: Juha Hartikainen, MD | |
| Netherlands | |
| Diakonessenhuis Utrecht | Active, not recruiting |
| 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 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 23, 2013