- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02041702
Accent Cardiac MRI Study (Accent Cardiac)
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Hong Kong, Hong Kong
- Prince of Wales Hospital
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Ahmedabad, Indien
- Care Institute of Medical Sciences
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Bhubaneshwar, Indien
- Apollo Hospitals, Bhubaneshwar
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Gurgaon, Indien
- Medanta - The Medicity Hospital
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New Delhi, Indien
- All India Institute of Medical Sciences, New Delhi
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New Delhi, Indien
- Fortis Escorts Heart Institute and Research Center
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New Delhi, Indien
- Fortis Flt. Lt. Rajan Dhall Hospital
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Punjab
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Mohali, Punjab, Indien
- 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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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Ingen indgriben: Kontrolgruppe
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Eksperimentel: Cardiac MRI Scan Group
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Freedom From MRI Scan-related Complications
Tidsramme: MRI Visit ,1 Month Post MRI Visit
|
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
|
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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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Chi Keong Ching, Dr, National Heart Center Singapore
- Ledende efterforsker: Rabindra Nath Chakraborty, Dr, Apollo Gleneagles Hospital Kolkata India
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CR-13-031-AP-LV
Plan for individuelle deltagerdata (IPD)
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