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

19 oktober 2020 uppdaterad av: Abbott Medical Devices

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

950

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Lead Safety
Patient implanted with an Accent MRI system to evaluate safety of the Tendril MRI lead
Enhet: Accent MRI system (lead safety)
Patients implanted with an Accent MRI system
Andra namn:
  • Accent MRI pacemaker
  • Tendril MRI lead
Experimentell: 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
Enhet: Accent MRI system (with MRI scan)
Patients implanted with an Accent MRI system will receive an MRI scan
Andra namn:
  • Accent MRI pacemaker
  • Tendril MRI lead

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Freedom From Right Atrial (RA) Lead-related Complications in the Acute Period
Tidsram: Implant through 2 months
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
Tidsram: Implant through 2 months
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
Tidsram: 2 months through 12 months
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
Tidsram: 2 months through 12 months
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
Tidsram: MRI Scan visit through 1 month after MRI scan visit
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
Tidsram: MRI Scan visit to 1 month after MRI scan visit
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
Tidsram: MRI Scan visit to 1 month after MRI scan visit
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
Tidsram: MRI Scan visit to 1 month after MRI scan visit
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
Tidsram: MRI Scan visit to 1 month after the MRI Scan visit
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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Freedom From System-related Complications
Tidsram: Implant through 12 months
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
Tidsram: MRI Scan visit (approx 3 months post implant)
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
Tidsram: MRI Scan visit (approx 3 months post implant)
Percentage of patients with RV capture threshold ≤2.0 V at the MRI visit
MRI Scan visit (approx 3 months post implant)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Abbott Medical Devices

Utredare

  • Studierektor: Grant Kim, Abbott Medical Devices

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

30 mars 2012

Primärt slutförande (Faktisk)

2 februari 2018

Avslutad studie (Faktisk)

2 februari 2018

Studieregistreringsdatum

Först inskickad

4 april 2012

Först inskickad som uppfyllde QC-kriterierna

10 april 2012

Första postat (Uppskatta)

12 april 2012

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 november 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

19 oktober 2020

Senast verifierad

1 oktober 2020

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • 60028820

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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