N/A
N=60
China (CN)_Magnetic Resonance Imaging (MRI)_Implantable Cardiac Defibrillator (ICD) [CN_MRI_ICD]
Tachycardia
Bottom Line
View on ClinicalTrials.gov: NCT03828357 ↗Enrolled (actual)
60
Serious AEs
14.5%
Results posted
Dec 2023
Primary outcome: Primary: Number of Participants With Freedom From Magnetic Resonance Imaging (MRI) Scan Related Complications — 14; 14; 15; 12 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Study MRI scan (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Freedom From Magnetic Resonance Imaging (MRI) Scan Related Complications |
14; 14; 15; 12 | — |
| PRIMARY Effectiveness Outcomes: Percentage of Leads With a Capture Threshold Increase |
NA; 100; 100; 100; 100; 100 | — |
| PRIMARY The Percentage of Leads With a Sensing Amplitude Decrease of ≤ 50% From Pre-MRI Scan Testing to 1-month Post-MRI Scan. |
NA; 100; 100; 92; 100; 100 | — |
| SECONDARY Device Electrical Measurements |
0.72; 0.75; 0.80; 0.7; 0.0113; 0.0110 | — |
| SECONDARY Number of Participants With Whole Body (WB) SAR Values Measured ≥ 1.8 W/kg |
14; 13; 13; 12 | — |
| SECONDARY Summary of Subjects That Returned to Usual Programming |
14; 14; 15; 12; 0; 0 | — |
Summary
This clinical study is to evaluate the safety and effectiveness of the Ellipse VR/DR implantable cardiac defibrillators (ICDs) and the Quadra Assura MP cardiac resynchronization therapy defibrillators (CRT-Ds), with Durata or Optisure defibrillation leads, Tendril STS or Isoflex pacing leads, and the Quartet quadripolar leads in a 1.5T MRI environment for MR-conditional labeling expansion of these market-approved ICD/CRT-D systems in China.
Note: Protocol updated: Fortify Assura VR/DR ICD removed; Quadra Assura MP CRT-D and Quartet leads added. The Detailed Description Section below was updated upon protocol amendment.
Eligibility Criteria
Inclusion Criteria
To participate in this clinical study, the subject must meet all of the following inclusion criteria:
- Have an approved indication for implantation of a ICD
- Be a Chinese national
- Will be implanted with one of the following device/lead combinations evaluated in this study:
- Group 1: Ellipse VR single-chamber ICD with a Durata lead in the right ventricle (RV)
- Group 2: Fortify Assura single-chamber ICD, with an Optisure lead
- Group 3: Ellipse DR dual-chamber ICD with a Durata lead in the RV and a Tendril STS lead in the right atrium (RA)
- Group 4: Fortify Assura ICD and an Optisure lead in the RV and an Isoflex lead in the RA
- Be willing to undergo an elective MRI scan without sedation ≥ 45 days after implant NOTE: Antianxiety agents (e.g. minor tranquilizers, etc.) may be used as long as the patient can communicate with site personnel during the MRI scan
- Be able to provide informed consent for study participation (legal guardian or legally authorized representative is NOT acceptable)
- Be willing and able to comply with the prescribed follow-up tests and procedures
- Are not contraindicated for an MRI scan (per the MRI Screening Form)
- Subjects who are at least 18 years of age (or older, required by local law)
Exclusion Criteria
Subjects who meet any of the following exclusion criteria must be excluded from the clinical investigation:
- Have a competitor's MRI compatible endocardial lead implanted or capped
- Have another existing active implanted medical device, e.g., neurostimulator, infusion pump, etc. that has MR labeling that will not allow the MRI scans per this protocol to be completed.
- Have other non-MRI compatible device or material implanted. The following examples may be included as long as labelling of these devices allow MRI scans conducted per this protocol:
- MRI compatible knee replacements, hip replacements, stents, etc.
- MRI compatible mechanical, prosthetic, and bio prosthetic heart valves
- Non-removable dental implants
- Have a lead extender, adaptor, or capped/abandoned lead
- Enrolled or intend to participate in a clinical drug and/or device study (investigational device, investigational drug, new indication for a device or drug or additional testing beyond standard of care procedures), which could confound the results of this study as determined by Abbott.
- Pregnant or planning to become pregnant during the duration of the subject's participation in the study
- Have a life expectancy of less than 12 months due to any condition
Data sourced from ClinicalTrials.gov (NCT03828357). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.