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

Accent Magnetic Resonance Imaging Pacemaker and Tendril Magnetic Resonance Imaging™ Lead Investigational Device Exemption Study

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.

Study Overview

• Status: Completed
• Conditions: Adverse Effect of MRI on an Implanted Pacemaker Lead; Adverse Effect of MRI on an Implanted Pacemaker
• Intervention / Treatment: Device: Accent MRI system (lead safety); Device: Accent MRI system (with MRI scan)

Detailed Description

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. The study consisted of two phases, a Lead Safety Phase which evaluated the safety of the Tendril MRI lead, and an MRI Phase which evaluated the safety and efficacy of the Accent MRI pacemaker system in an MRI environment.

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 right atrial (RA) and right ventricle (RV) lead-related complications at implant to 2 months (acute timeframe), and at the 2 through the 12 month visit (chronic timeframe).

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.

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

Secondary Endpoints Safety Safety of the Accent MRI™ 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.

• Study Type: Interventional
• Enrollment (Actual): 950
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Eligible patients will meet all of the following:

1. Have an approved indication per American College of Cardiology (ACC)/American Heart Association (AHA)/Heart Rhythm Society (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 implantable cardioverter defibrillator (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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lead Safety; Patient implanted with an Accent MRI system to evaluate safety of the Tendril MRI lead	Device: Accent MRI system (lead safety); Patients implanted with an Accent MRI system; Other Names: Accent MRI pacemaker; Tendril MRI lead
Experimental: Accent MRI system MRI Scan Group; Patient implanted with an Accent MRI system will receive an MRI scan to evaluate safety and efficacy of the Accent MRI system in an MRI environment	Device: Accent MRI system (with MRI scan); Patients implanted with an Accent MRI system will receive an MRI scan; Other Names: Accent MRI pacemaker; Tendril MRI lead

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom From Right Atrial (RA) Lead-related Complications in the Acute Period	Percentage of patients who do not have RA lead-related complications from implant through the 2 month study visit	Implant through 2 months
Freedom From Right Ventricular (RV) Lead-related Complications in the Acute Time Period	Percentage of patients who do not have RV lead-related complications from implant through the 2 month study visit	Implant through 2 months
Freedom From RA Related Complications in the Chronic Period	Percentage of patients who do not have RA lead-related complications from the 2 month through the 12 month study visit	2 months through 12 months
Freedom From Right Ventricular Lead Related Complications in the Chronic Period	Percentage of patients who do not have RV lead-related complications from the 2 month through the 12 month study visit	2 months through 12 months
Freedom From MRI Scan-related Complications	Percentage of patients who do not have MRI-related complications from the MRI scan visit to the 1 month post MRI scan visit	MRI Scan visit through 1 month after MRI scan visit
Change in Atrial Capture Threshold From Pre to Post MRI Scan	Percentage of patients with an increase in RA capture thresholds of <= 0.5 V, at a pulse width of 0.5 ms .	MRI Scan visit to 1 month after MRI scan visit
Change in Ventricular Capture Threshold Pre to Post MRI Scan	Percentage of patients with an increase in RV capture thresholds of <=0.5V, at a pulse width of 0.5 ms.	MRI Scan visit to 1 month after MRI scan visit
Change in Atrial Sense Amplitude	Percentage of patients with a reduction in RA sense amplitude <=50 % and sense amplitude >=1.5 mV.	MRI Scan visit to 1 month after MRI scan visit
Change in Ventricular Sense Amplitude	Percentage of patients with an reduction in RV sense amplitude <=50% and sense amplitude >=5 mV.	MRI Scan visit to 1 month after the MRI Scan visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom From System-related Complications	Percentage of patients who do not have system-related complications from implant through the 12 month study visit	Implant through 12 months
Atrial Capture Threshold at the MRI Visit	Percentage of patients with RA capture threshold ≤2.0 volts (V) at the MRI visit	MRI Scan visit (approx 3 months post implant)
Ventricular Capture Threshold at the MRI Visit	Percentage of patients with RV capture threshold ≤2.0 V at the MRI visit	MRI Scan visit (approx 3 months post implant)

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: Grant Kim, Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2012
• Primary Completion (Actual): February 2, 2018
• Study Completion (Actual): February 2, 2018

Study Registration Dates

• First Submitted: April 4, 2012
• First Submitted That Met QC Criteria: April 10, 2012
• First Posted (Estimate): April 12, 2012

Study Record Updates

• Last Update Posted (Actual): November 10, 2020
• Last Update Submitted That Met QC Criteria: October 19, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: bradycardia; MRI scans
• Other Study ID Numbers: 60028820