Implantable Defibrillator User
Conditions
Brief summary
To demonstrate safety and efficacy of the Durata or Optisure high voltage lead and Ellipse VR ICD in an MRI environment.
Detailed description
The intent of this IDE study is to evaluate the safety and efficacy of the Durata or Optisure lead and Ellipse VR ICD that have undergone an MRI scan. The patient population under study includes patients indicated for or who have been implanted with a Durata or Optisure lead and an Ellipse VR ICD.
Interventions
DEVICEEllipse VR ICD and Durata/Optisure lead
Non-diagnostic MRI Scan sequence of head and chest
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Are implanted with the Durata or Optisure lead for at least 60 days (can include patients with Durata or Optisure lead for \> 60 days OR patients with a new Ellipse VR ICD and/or Durata/Optisure lead implanted for at least 60 days * Are implanted with an Ellipse VR ICD pectorally * Be willing to undergo an elective MRI scan without sedation 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 * Capture threshold is stable \< 2.5V @ 0.5ms * Ventricular sensing is measurable (patient has underlying rhythm \> 30bpm) and the sensing amplitude is \> 4mV * 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)
Exclusion criteria
* 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 a lead revision of the Durata/Optisure lead occur \< 60 days of the baseline visit * Have other non-MRI compatible device or material implanted NOTE: MRI compatible knee replacements, hip replacements, stents, etc. may be included as long as the labeling of these devices allow MRI scans conducted per this protocol NOTE: MRI compatible mechanical, prosthetic, and bioprosthetic heart valves may be included as long as the labeling of these devices allow for MRI scans conducted per this protocol NOTE: Non-removable dental implants may be included * 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 trial as determined by SJM. * 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 * Patients with
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With MRI Scan Related Complications | MRI scan to 1 month post MRI scan | The primary safety endpoint is the number of participants that had an Ellipse ICD and/or a Durata or Optisure lead complication from the day the MRI scan occurred to the 1-month visit. A complication is defined as a serious adverse device effect that requires an invasive intervention or leads to death. |
| Percentage of Participants With Ventricular Capture Threshold ≤ to 0.5V | pre-MRI scan to 1 month post MRI scan | Percentage of participants of Durata or Optisure (RV) leads implanted with the Ellipse VR ICD with capture threshold increase of ≤ 0.5V at 0.5ms from pre-MRI scan to 1 month post-MRI scan. |
| Percentage of Participants With Ventricular Sensing Amplitude Decrease of ≤ 50% From Pre-MRI Scan to 1 Month Post MRI Scan | pre-MRI scan to 1 month post MRI scan | Percentage of Participants with Durata or Optisure RV leads implanted with the Ellipse VR ICD with sensing amplitude decrease of ≤ 50% from pre-MRI scan to 1 month post MRI scan. |
Countries
Hungary, Poland, Spain, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ellipse VR ICD and Durata/Optisure Lead Pts with Ellipse VR ICD and Durata or Optisure RV lead implanted for at least 60 days will receive a non-diagnostic MRI scan of head and chest region
Ellipse VR ICD and Durata/Optisure lead: Non-diagnostic MRI Scan sequence of head and chest | 227 |
| Total | 227 |
Baseline characteristics
| Characteristic | Ellipse VR ICD and Durata/Optisure Lead |
|---|---|
| Age, Continuous | 61.9 years STANDARD_DEVIATION 11.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 207 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 23 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 201 Participants |
| Region of Enrollment Hungary | 21 participants |
| Region of Enrollment Poland | 64 participants |
| Region of Enrollment Spain | 18 participants |
| Region of Enrollment United Kingdom | 11 participants |
| Region of Enrollment United States | 113 participants |
| Sex: Female, Male Female | 41 Participants |
| Sex: Female, Male Male | 186 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 227 |
| other Total, other adverse events | 0 / 227 |
| serious Total, serious adverse events | 0 / 227 |
Outcome results
Primary
Number of Participants With MRI Scan Related Complications
The primary safety endpoint is the number of participants that had an Ellipse ICD and/or a Durata or Optisure lead complication from the day the MRI scan occurred to the 1-month visit. A complication is defined as a serious adverse device effect that requires an invasive intervention or leads to death.
Time frame: MRI scan to 1 month post MRI scan
Population: Of 227 subjects enrolled, 209 subjects completed the pre-MRI scan visit. Of the 209 subjects, 4 subjects did not have eligible study leads, 3 withdrew before 1-month post MRI scan visit and 4 missed 1-month post MRI scan visit. Therefore, 198 subjects who completed 1-month post MRI scan were included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ellipse VR ICD and Durata/Optisure Lead | Number of Participants With MRI Scan Related Complications | 0 Participants |
Primary
Percentage of Participants With Ventricular Capture Threshold ≤ to 0.5V
Percentage of participants of Durata or Optisure (RV) leads implanted with the Ellipse VR ICD with capture threshold increase of ≤ 0.5V at 0.5ms from pre-MRI scan to 1 month post-MRI scan.
Time frame: pre-MRI scan to 1 month post MRI scan
Population: Of 227 subjects enrolled, 209 subjects completed the pre-MRI scan visit. Of the 209 subjects, 4 did not have eligible study leads, 13 were missing capture threshold measurements, 3 withdrew before the 1-month post MRI scan visit and 2 missed the 1-month post MRI scan visit. Therefore, 187 subjects were included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ellipse VR ICD and Durata/Optisure Lead | Percentage of Participants With Ventricular Capture Threshold ≤ to 0.5V | 0 Participants |
Primary
Percentage of Participants With Ventricular Sensing Amplitude Decrease of ≤ 50% From Pre-MRI Scan to 1 Month Post MRI Scan
Percentage of Participants with Durata or Optisure RV leads implanted with the Ellipse VR ICD with sensing amplitude decrease of ≤ 50% from pre-MRI scan to 1 month post MRI scan.
Time frame: pre-MRI scan to 1 month post MRI scan
Population: Of 227 subjects enrolled, 209 subjects completed the pre-MRI scan visit. Of the 209 subjects, 4 subjects did not have eligible study leads, 3 withdrew before 1-month post MRI scan visit and 4 missed 1-month post MRI scan visit. Therefore, 198 subjects who completed 1-month post MRI scan were included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ellipse VR ICD and Durata/Optisure Lead | Percentage of Participants With Ventricular Sensing Amplitude Decrease of ≤ 50% From Pre-MRI Scan to 1 Month Post MRI Scan | 0 Participants |