Safety and Efficacy of the Accent Magnetic Resonance Imaging™ (MRI) Pacemaker and Tendril MRI™ Lead
19. oktober 2020 oppdatert 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
950
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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South Australia
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Adelaide, South Australia, Australia, 5000
- St. Andrews Hospital
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B Cap R
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Brussels, B Cap R, Belgia, 1200
- Cliniques Universitaires Saint Luc
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East Finland
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Kuopio, East Finland, Finland, 70211
- Kuopio University Hospital
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Alabama
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Birmingham, Alabama, Forente stater, 35233
- University Hospital of Alabama at Birmingham
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Huntsville, Alabama, Forente stater, 35801
- Heart Center Research
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Arizona
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Phoenix, Arizona, Forente stater, 85016
- Arizona Arrhythmia Research Center
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Arkansas
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Little Rock, Arkansas, Forente stater, 72211
- Arkansas Heart Hospital
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Little Rock, Arkansas, Forente stater, 72205
- Baptist Health Medical Center
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Rogers, Arkansas, Forente stater, 72758
- Mercy Hospital Northwest Arkansas
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California
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Bakersfield, California, Forente stater, 93308
- Central Cardiology
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Burbank, California, Forente stater, 91505
- Raymond Schaerf, MD
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Concord, California, Forente stater, 94520
- John Muir Medical Center
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Fullerton, California, Forente stater, 92835
- St. Jude Hospital
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Glendale, California, Forente stater, 91206
- Glendale Adventist Medical Center
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La Jolla, California, Forente stater, 92037
- Scripps Green Hospital
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Modesto, California, Forente stater, 95355
- Memorial Medical Center
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Newport Beach, California, Forente stater, 92629
- Premier Cardiology, Inc / Hoag Hospital
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Rancho Mirage, California, Forente stater, 92270
- Desert Cardiology Consultants
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Sacramento, California, Forente stater, 95819
- Mercy General Hospital
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Sacramento, California, Forente stater, 95819
- Sutter Memorial Hospital
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Colorado
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Denver, Colorado, Forente stater, 80012
- Aurora Denver Cardiology Associates
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Littleton, Colorado, Forente stater, 80120
- South Denver Cardiology Associates PC
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Loveland, Colorado, Forente stater, 80538
- Medical Center of the Rockies
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Florida
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Atlantis, Florida, Forente stater, 33462
- Medical Specialists of the Palm Beaches
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Lakeland, Florida, Forente stater, 33647
- Watson Clinic Center
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Orlando, Florida, Forente stater, 32803
- Florida Hospital Orlando
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Orlando, Florida, Forente stater, 32806
- Orlando Health
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Rockledge, Florida, Forente stater, 32955
- Brevard Cardiovascular Research Associates
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Tallahassee, Florida, Forente stater, 32308
- Tallahassee Research Institute
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Tampa, Florida, Forente stater, 33606
- University of South Florida, Cardiovascular Services
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Georgia
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Athens, Georgia, Forente stater, 30606
- Athens Cardiology Group, PC
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Atlanta, Georgia, Forente stater, 30041
- Atlanta Heart Specialist
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Illinois
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Springfield, Illinois, Forente stater, 62701
- Prairie Education And Research Cooperative
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Kentucky
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Lexington, Kentucky, Forente stater, 40503
- Central Baptist Hospital
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Louisiana
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New Orleans, Louisiana, Forente stater, 70121
- Ochsner Medical Center
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Michigan
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Grand Rapids, Michigan, Forente stater, 49503
- Spectrum Health
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Lansing, Michigan, Forente stater, 48910
- Thoracic Cardio Healthcare Foundation
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Southfield, Michigan, Forente stater, 48075
- Providence Hospital
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Minnesota
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Minneapolis, Minnesota, Forente stater, 55407
- Minneapolis Heart Institute
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Missouri
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Kansas City, Missouri, Forente stater, 64111
- St. Luke's Hospital
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Saint Louis, Missouri, Forente stater, 63110
- Washington University School of Medicine
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Saint Louis, Missouri, Forente stater, 63131
- Missouri Baptist Medical Center
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Nebraska
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Omaha, Nebraska, Forente stater, 68124
- Alegent Creighton Health
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New York
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Rochester, New York, Forente stater, 14450
- University of Rochester Medical Center
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North Carolina
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Chapel Hill, North Carolina, Forente stater, 27599-7075
- University of North Carolina at Chapel Hill
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Charlotte, North Carolina, Forente stater, 28204
- Mid Carolina Cardiology
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Winston-Salem, North Carolina, Forente stater, 27615
- Wake Forest University Medical Center Clinical Sciences
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Ohio
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Cleveland, Ohio, Forente stater, 44195
- The Cleveland Clinic Foundation
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Columbus, Ohio, Forente stater, 43210
- The Ohio State University
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Columbus, Ohio, Forente stater, 43213
- Columbus Cardiovascular Associates
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Elyria, Ohio, Forente stater, 44035
- EMH Regional Medical Center
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Youngstown, Ohio, Forente stater, 44501
- St. Elizabeth Health Center
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Oklahoma
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Oklahoma City, Oklahoma, Forente stater, 73112
- Integris Baptist Medical Center
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Tulsa, Oklahoma, Forente stater, 73112
- Oklahoma Heart Institute at Utica
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Pennsylvania
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Abington, Pennsylvania, Forente stater, 72758
- Abington Medical Specialists
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Pittsburgh, Pennsylvania, Forente stater, 15212
- Allegheny Singer Research Institute
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Sayre, Pennsylvania, Forente stater, 18840
- Donald Guthrie Foundation for Education and Research
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York, Pennsylvania, Forente stater, 17403
- York Hospital
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South Carolina
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Charleston, South Carolina, Forente stater, 29401
- Medical University of South Carolina
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Charleston, South Carolina, Forente stater, 29406
- PMG Research of Charleston, LLC
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Texas
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Austin, Texas, Forente stater, 78756
- Austin Heart
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San Antonio, Texas, Forente stater, 78201
- South Texas Cardiovascular Consultants
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Temple, Texas, Forente stater, 76508
- Scott & White Memorial Hospital
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Virginia
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Charlottesville, Virginia, Forente stater, 22911
- Martha Jefferson Hospital
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Manassas, Virginia, Forente stater, 20109
- Virginia Cardiovascular Associates, PC
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Norfolk, Virginia, Forente stater, 23507
- Sentara Norfolk General Hospital
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Washington
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Bremerton, Washington, Forente stater, 98310
- Kitsap Cardiology Consultants
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Seattle, Washington, Forente stater, 98101
- The Heart Institute at Virginia Mason
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Wisconsin
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Milwaukee, Wisconsin, Forente stater, 14450
- Aurora Medical Group
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Utrecht, Nederland, 3582 KE
- Diakonessenhuis Utrecht
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
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)
Exclusion Criteria:
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
- 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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Lead Safety
Patient implanted with an Accent MRI system to evaluate safety of the Tendril MRI lead
|
Patients implanted with an Accent MRI system
Andre navn:
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Eksperimentell: 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
|
Patients implanted with an Accent MRI system will receive an MRI scan
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
|
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Freedom From MRI Scan-related Complications
Tidsramme: MRI Scan visit through 1 month after MRI scan visit
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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
|
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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
|
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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.
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MRI Scan visit to 1 month after MRI scan visit
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Change in Atrial Sense Amplitude
Tidsramme: MRI Scan visit to 1 month after MRI scan visit
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Percentage of patients with a reduction in RA sense amplitude <=50 % and sense amplitude >=1.5 mV.
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MRI Scan visit to 1 month after MRI scan visit
|
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Change in Ventricular Sense Amplitude
Tidsramme: MRI Scan visit to 1 month after the MRI Scan visit
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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 |
Tiltaksbeskrivelse |
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)
|
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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)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Grant Kim, Abbott Medical Devices
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
30. mars 2012
Primær fullføring (Faktiske)
2. februar 2018
Studiet fullført (Faktiske)
2. februar 2018
Datoer for studieregistrering
Først innsendt
4. april 2012
Først innsendt som oppfylte QC-kriteriene
10. april 2012
Først lagt ut (Anslag)
12. april 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
10. november 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. oktober 2020
Sist bekreftet
1. oktober 2020
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 60028820
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .