Trial Outcomes & Findings for A Clinical Evaluation of the Durata or Optisure High Voltage Leads and Ellipse VR ICD Undergoing MRI, an IDE Study (NCT NCT02787291)

Last Updated: 2020-09-03

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

227 participants

Primary outcome timeframe

MRI scan to 1 month post MRI scan

Results posted on

2020-09-03

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	227
Overall Study COMPLETED	227
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Clinical Evaluation of the Durata or Optisure High Voltage Leads and Ellipse VR ICD Undergoing MRI, an IDE Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ellipse VR ICD and Durata/Optisure Lead n=227 Participants 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
Age, Continuous	61.9 years STANDARD_DEVIATION 11.2 • n=99 Participants
Sex: Female, Male Female	41 Participants n=99 Participants
Sex: Female, Male Male	186 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	20 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	207 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	3 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	23 Participants n=99 Participants
Race (NIH/OMB) White	201 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment Hungary	21 participants n=99 Participants
Region of Enrollment United States	113 participants n=99 Participants
Region of Enrollment Poland	64 participants n=99 Participants
Region of Enrollment United Kingdom	11 participants n=99 Participants
Region of Enrollment Spain	18 participants n=99 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ellipse VR ICD and Durata/Optisure Lead n=198 Participants 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
Number of Participants With MRI Scan Related Complications	0 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Ellipse VR ICD and Durata/Optisure Lead n=187 Participants 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
Percentage of Participants With Ventricular Capture Threshold ≤ to 0.5V	0 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ellipse VR ICD and Durata/Optisure Lead n=198 Participants 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
Percentage of Participants With Ventricular Sensing Amplitude Decrease of ≤ 50% From Pre-MRI Scan to 1 Month Post MRI Scan	0 Participants

Adverse Events

Ellipse VR ICD and Durata/Optisure Lead

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Adam Cline- Clinical Scientist

Abbott CAHF CRM

Phone: 818-493-2025

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60