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

19 oktober 2020 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

950

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Lead Safety
Patient implanted with an Accent MRI system to evaluate safety of the Tendril MRI lead
Apparaat: Accent MRI system (lead safety)
Patients implanted with an Accent MRI system
Andere namen:
  • Accent MRI pacemaker
  • Tendril MRI lead
Experimenteel: 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
Apparaat: Accent MRI system (with MRI scan)
Patients implanted with an Accent MRI system will receive an MRI scan
Andere namen:
  • Accent MRI pacemaker
  • Tendril MRI lead

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Freedom From Right Atrial (RA) Lead-related Complications in the Acute Period
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Freedom From System-related Complications
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Abbott Medical Devices

Onderzoekers

  • Studie directeur: Grant Kim, Abbott Medical Devices

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

30 maart 2012

Primaire voltooiing (Werkelijk)

2 februari 2018

Studie voltooiing (Werkelijk)

2 februari 2018

Studieregistratiedata

Eerst ingediend

4 april 2012

Eerst ingediend dat voldeed aan de QC-criteria

10 april 2012

Eerst geplaatst (Schatting)

12 april 2012

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 november 2020

Laatste update ingediend die voldeed aan QC-criteria

19 oktober 2020

Laatst geverifieerd

1 oktober 2020

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • 60028820

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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Locaties

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