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Adverse Effect of MRI on an Implanted Pacemaker LeadNCT01576016

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

A study testing Accent MRI system (lead safety) and Accent MRI system (with MRI scan) in people with Adverse Effect of MRI on an Implanted Pacemaker Lead and Adverse Effect of MRI on an Implanted Pacemaker, run by Abbott Medical Devices at 70 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any age
What is being tested?
Accent MRI system (lead safety) and Accent MRI system (with MRI scan)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
950 participants
Where
70 sitesin 5 countries
Study dates
30 Mar 2012to 2 Feb 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Eligible patients will meet all of the following:
  • Have an approved indication per American College of Cardiology (ACC)/American Heart Association (AHA)/Heart Rhythm Society (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)

Who cannot join

  • 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 implantable cardioverter defibrillator (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
Show all 14Show fewer
  • 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

Trial locations and contacts

70 sites in 5 countries.

70 sites in 5 countries

United States66 sites

  • Abington Medical Specialists

    Abington, Pennsylvania, 72758

  • Athens Cardiology Group, PC

    Athens, Georgia, 30606

  • Atlanta Heart Specialist

    Atlanta, Georgia, 30041

  • Medical Specialists of the Palm Beaches

    Atlantis, Florida, 33462

  • Austin Heart

    Austin, Texas, 78756

  • Central Cardiology

    Bakersfield, California, 93308

  • University Hospital of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Kitsap Cardiology Consultants

    Bremerton, Washington, 98310

  • Raymond Schaerf, MD

    Burbank, California, 91505

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599-7075

  • Medical University of South Carolina

    Charleston, South Carolina, 29401

  • PMG Research of Charleston, LLC

    Charleston, South Carolina, 29406

  • Mid Carolina Cardiology

    Charlotte, North Carolina, 28204

  • Martha Jefferson Hospital

    Charlottesville, Virginia, 22911

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • The Ohio State University

    Columbus, Ohio, 43210

  • Columbus Cardiovascular Associates

    Columbus, Ohio, 43213

  • John Muir Medical Center

    Concord, California, 94520

  • Aurora Denver Cardiology Associates

    Denver, Colorado, 80012

  • EMH Regional Medical Center

    Elyria, Ohio, 44035

  • St. Jude Hospital

    Fullerton, California, 92835

  • Glendale Adventist Medical Center

    Glendale, California, 91206

  • Spectrum Health

    Grand Rapids, Michigan, 49503

  • Heart Center Research

    Huntsville, Alabama, 35801

  • St. Luke's Hospital

    Kansas City, Missouri, 64111

  • Scripps Green Hospital

    La Jolla, California, 92037

  • Watson Clinic Center

    Lakeland, Florida, 33647

  • Thoracic Cardio Healthcare Foundation

    Lansing, Michigan, 48910

  • Central Baptist Hospital

    Lexington, Kentucky, 40503

  • Baptist Health Medical Center

    Little Rock, Arkansas, 72205

  • Arkansas Heart Hospital

    Little Rock, Arkansas, 72211

  • South Denver Cardiology Associates PC

    Littleton, Colorado, 80120

  • Medical Center of the Rockies

    Loveland, Colorado, 80538

  • Virginia Cardiovascular Associates, PC

    Manassas, Virginia, 20109

  • Aurora Medical Group

    Milwaukee, Wisconsin, 14450

  • Minneapolis Heart Institute

    Minneapolis, Minnesota, 55407

  • Memorial Medical Center

    Modesto, California, 95355

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121

  • Premier Cardiology, Inc / Hoag Hospital

    Newport Beach, California, 92629

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • Integris Baptist Medical Center

    Oklahoma City, Oklahoma, 73112

  • Alegent Creighton Health

    Omaha, Nebraska, 68124

  • Florida Hospital Orlando

    Orlando, Florida, 32803

  • Orlando Health

    Orlando, Florida, 32806

  • Arizona Arrhythmia Research Center

    Phoenix, Arizona, 85016

  • Allegheny Singer Research Institute

    Pittsburgh, Pennsylvania, 15212

  • Desert Cardiology Consultants

    Rancho Mirage, California, 92270

  • University of Rochester Medical Center

    Rochester, New York, 14450

  • Brevard Cardiovascular Research Associates

    Rockledge, Florida, 32955

  • Mercy Hospital Northwest Arkansas

    Rogers, Arkansas, 72758

  • Mercy General Hospital

    Sacramento, California, 95819

  • Sutter Memorial Hospital

    Sacramento, California, 95819

  • South Texas Cardiovascular Consultants

    San Antonio, Texas, 78201

  • Donald Guthrie Foundation for Education and Research

    Sayre, Pennsylvania, 18840

  • The Heart Institute at Virginia Mason

    Seattle, Washington, 98101

  • Providence Hospital

    Southfield, Michigan, 48075

  • Prairie Education and Research Cooperative

    Springfield, Illinois, 62701

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • Tallahassee Research Institute

    Tallahassee, Florida, 32308

  • University of South Florida, Cardiovascular Services

    Tampa, Florida, 33606

  • Scott & White Memorial Hospital

    Temple, Texas, 76508

  • Oklahoma Heart Institute at Utica

    Tulsa, Oklahoma, 73112

  • Wake Forest University Medical Center Clinical Sciences

    Winston-Salem, North Carolina, 27615

  • York Hospital

    York, Pennsylvania, 17403

  • St. Elizabeth Health Center

    Youngstown, Ohio, 44501

Other trials in United States

Australia1 site

  • St. Andrews Hospital

    Adelaide, South Australia, 5000

Other trials in Australia

Belgium1 site

  • Cliniques Universitaires Saint Luc

    Brussels, B CAP R, 1200

Other trials in Belgium

Finland1 site

  • Kuopio University Hospital

    Kuopio, East Finland, 70211

Other trials in Finland

Netherlands1 site

  • Diakonessenhuis Utrecht

    Utrecht, 3582 KE

Other trials in Netherlands

About this study

Official title: 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.

Read the 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.

Being tested
Accent MRI system (lead safety), Accent MRI system (with MRI scan)
Keywords
bradycardia, MRI scans
Medical subject headings
Bradycardia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Accent MRI system (lead safety)Device

    Also called Accent MRI pacemaker, Tendril MRI lead

    Patients implanted with an Accent MRI system

  • Accent MRI system (with MRI scan)Device

    Also called Accent MRI pacemaker, Tendril MRI lead

    Patients implanted with an Accent MRI system will receive an MRI scan

Study groups in NCT01576016
Study groupRoleWhat they receive
Lead SafetyExperimentalPatient implanted with an Accent MRI system to evaluate safety of the Tendril MRI lead
Receives: Device: Accent MRI system (lead safety)
Accent MRI system MRI Scan GroupExperimentalPatient 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
Receives: Device: Accent MRI system (with MRI scan)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Implant through 2 months

  2. 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

    Measured: Implant through 2 months

  3. 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

    Measured: 2 months through 12 months

  4. 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

    Measured: 2 months through 12 months

  5. 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

    Measured: MRI Scan visit through 1 month after MRI scan visit

  6. 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 .

    Measured: MRI Scan visit to 1 month after MRI scan visit

  7. 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.

    Measured: MRI Scan visit to 1 month after MRI scan visit

  8. Change in Atrial Sense Amplitude

    Percentage of patients with a reduction in RA sense amplitude <=50 % and sense amplitude >=1.5 mV.

    Measured: MRI Scan visit to 1 month after MRI scan visit

  9. Change in Ventricular Sense Amplitude

    Percentage of patients with an reduction in RV sense amplitude <=50% and sense amplitude >=5 mV.

    Measured: MRI Scan visit to 1 month after the MRI Scan visit

Secondary outcomes (3)

  1. Freedom From System-related Complications

    Percentage of patients who do not have system-related complications from implant through the 12 month study visit

    Measured: Implant through 12 months

  2. Atrial Capture Threshold at the MRI Visit

    Percentage of patients with RA capture threshold ≤2.0 volts (V) at the MRI visit

    Measured: MRI Scan visit (approx 3 months post implant)

  3. Ventricular Capture Threshold at the MRI Visit

    Percentage of patients with RV capture threshold ≤2.0 V at the MRI visit

    Measured: MRI Scan visit (approx 3 months post implant)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2012 (estimated)
  2. Study start30 Mar 2012
  3. Primary completion2 Feb 2018
  4. Study completion2 Feb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
950 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01576016
Sponsor's protocol ID
60028820
Status last verified
Oct 2020
First submitted
4 Apr 2012
Last updated
10 Nov 2020
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Accent MRI system (lead safety) and Accent MRI system (with MRI scan) in people with Adverse Effect of MRI on an Implanted Pacemaker Lead and Adverse Effect of MRI on an Implanted Pacemaker, run by Abbott Medical Devices at 70 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 70 sites in United States, Australia, Belgium, Finland, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Freedom From Right Atrial (RA) Lead-related Complications in the Acute Period (time frame: Implant through 2 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01576016.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020.

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