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

19. oktober 2020 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

950

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Lead Safety
Patient implanted with an Accent MRI system to evaluate safety of the Tendril MRI lead
Enhed: Accent MRI system (lead safety)
Patients implanted with an Accent MRI system
Andre navne:
  • Accent MRI pacemaker
  • Tendril MRI lead
Eksperimentel: 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
Enhed: Accent MRI system (with MRI scan)
Patients implanted with an Accent MRI system will receive an MRI scan
Andre navne:
  • Accent MRI pacemaker
  • Tendril MRI lead

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Freedom From Right Atrial (RA) Lead-related Complications in the Acute Period
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Freedom From System-related Complications
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Abbott Medical Devices

Efterforskere

  • Studieleder: Grant Kim, Abbott Medical Devices

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

30. marts 2012

Primær færdiggørelse (Faktiske)

2. februar 2018

Studieafslutning (Faktiske)

2. februar 2018

Datoer for studieregistrering

Først indsendt

4. april 2012

Først indsendt, der opfyldte QC-kriterier

10. april 2012

Først opslået (Skøn)

12. april 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. november 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. oktober 2020

Sidst verificeret

1. oktober 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 60028820

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Accent MRI system (lead safety)

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Sponsorer og samarbejdspartnere

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Betingelser

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Sponsor / samarbejdspartnere

Placeringer

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