Accent Cardiac MRI Study (Accent Cardiac)
6. august 2019 oppdatert av: Abbott Medical Devices
A Clinical Evaluation of the Safety and Efficacy of St. Jude Medical (SJM) Magnetic Resonance Imaging (MRI) Conditional Pacing System in Patients Undergoing Cardiac MRI
The aim of this study was to assess safety and efficacy of SJM MRI conditional pacing system.
The study hypothesized that cardiac MRI scan would not affect performance of SJM MRI conditional pacing system.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Accent Cardiac MRI study was a prospective, randomized ,multi-center study conducted in Asia. Subjects indicated for dual-chamber pacemaker and who signed study consent form were considered enrolled and post implant were randomized to either Cardiac MRI Scan Group or Control Group.
Clinical evaluation and device interrogation were performed at baseline, pre- and post-MRI scan, and one month post-MRI for all subjects. At 9-12 weeks post-implant, patients in Cardiac MRI Scan Group underwent an elective non-diagnostic cardiac MRI scan at 1.5 Tesla (T) while patients in Control group underwent device interrogation and clinical evaluation twice with a 45-minute waiting period in between. The safety endpoint was freedom from MRI-related complications while efficacy endpoint was change in right atrial/ ventricular (RA/RV) capture threshold and sensing amplitude from pre-MRI scan to one month post-MRI scan.
Studietype
Intervensjonell
Registrering (Faktiske)
283
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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Hong Kong, Hong Kong
- Prince of Wales Hospital
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Ahmedabad, India
- Care Institute of Medical Sciences
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Bhubaneshwar, India
- Apollo Hospitals, Bhubaneshwar
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Gurgaon, India
- Medanta - The Medicity Hospital
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New Delhi, India
- All India Institute of Medical Sciences, New Delhi
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New Delhi, India
- Fortis Escorts Heart Institute and Research Center
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New Delhi, India
- Fortis Flt. Lt. Rajan Dhall Hospital
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Punjab
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Mohali, Punjab, India
- Fortis Hospital
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Hangzhou, Kina
- Zhejiang Greentown Cardiovascular Disease Hospital
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Kajang, Malaysia
- Serdang Hospital
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Bangkok, Thailand
- Siriraj Hospital
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Bangkok, Thailand
- Ramathibodi Hospital
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Bangkok, Thailand
- King Chulalongkorn Memorial Hospital
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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
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria
- Have an approved indication per American College of Cardiology(ACC)/ American Heart Association(AHA)/ Heart Rhythm Society(HRS)/ European Society of Cardiology(ESC) guidelines for implantation of a pacemaker
- Will receive a new dual chamber pacemaker and leads
- Be willing to undergo an elective MRI scan without complete sedation, that is ,under consciousness during MRI scan
- Be able to provide informed consent for study participation
- 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)
- Age≥18 years
- Subjects must be able to undergo pectoral implantation
Exclusion Criteria
- Having an existing pacemaker or Implantable Cardioverter Defibrillator (ICD) .A new pacemaker and lead is required for enrollment
- Permanent Atrial Fibrillation/Flutter
- Are medically indicated for an MRI scan at the time of enrollment
- Have an existing active implanted medical device, e.g. neurostimulator, infusion pump etc
- Have a non-MRI compatible device or material implanted
- 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
- 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
- Subjects 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: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Ingen inngripen: Kontrollgruppe
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Eksperimentell: Cardiac MRI Scan Group
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Freedom From MRI Scan-related Complications
Tidsramme: MRI Visit ,1 Month Post MRI Visit
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Number of subjects who were free from MRI scan-related complications
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MRI Visit ,1 Month Post MRI Visit
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Change in Right Atrial (RA) Capture Threshold @0.5 Millisecond (ms) From Pre-MRI Scan to 1 Month After MRI Scan
Tidsramme: MRI Visit ,1 Month Post MRI Visit
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Number of subjects who experienced an increase in RA capture threshold @ 0.5 ms at 1-Month post MRI scan visit ≤ 0.5 Volt (V) compared to pre-MRI scan value collected at MRI scan visit
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MRI Visit ,1 Month Post MRI Visit
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Change in Right Ventricular (RV) Capture Threshold @0.5ms From Pre-MRI Scan to 1 Month After MRI Scan
Tidsramme: MRI Visit, 1 Month Post MRI Visit
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Number of subjects who experienced an increase in RV capture threshold @ 0.5 ms at 1-Month post MRI scan visit ≤ 0.5 V compared to pre-MRI scan value collected at MRI scan visit
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MRI Visit, 1 Month Post MRI Visit
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Change in RA Sensing Amplitude From Pre-MRI Scan to 1 Month After MRI Scan
Tidsramme: MRI Visit, 1 Month Post MRI Visit
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Number of subjects who experienced a decrease in RA sensing amplitude ≤ 50% and at least 1.5 mV at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit
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MRI Visit, 1 Month Post MRI Visit
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Change in RV Sensing Amplitude From Pre-MRI Scan to 1 Month After MRI Scan
Tidsramme: MRI Visit, 1 Month Post MRI Visit
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Number of subjects who experienced a decrease in RV sensing amplitude ≤ 50% and at least 5 mV at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit
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MRI Visit, 1 Month Post MRI Visit
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Chi Keong Ching, Dr, National Heart Center Singapore
- Hovedetterforsker: Rabindra Nath Chakraborty, Dr, Apollo Gleneagles Hospital Kolkata India
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)
9. juni 2014
Primær fullføring (Faktiske)
17. mars 2016
Studiet fullført (Faktiske)
17. mars 2016
Datoer for studieregistrering
Først innsendt
20. desember 2013
Først innsendt som oppfylte QC-kriteriene
17. januar 2014
Først lagt ut (Anslag)
22. januar 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
21. august 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. august 2019
Sist bekreftet
1. august 2019
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CR-13-031-AP-LV
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