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

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02787291
• Collaborator: (none)
• Enrollment: 227
• Locations: 32
• Arm: 1
• Actual Duration (Months): 23.3
• Patients Per Site: 7.1
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

To demonstrate safety and efficacy of the Durata or Optisure high voltage lead and Ellipse VR ICD in an MRI environment.

Condition or Disease	Intervention/Treatment	Phase
Implantable Defibrillator User	Device: Ellipse VR ICD and Durata/Optisure lead	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 227 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Clinical Evaluation of the Durata or Optisure High Voltage Leads and Ellipse VR ICD Undergoing Magnetic Resonance Imaging, an Investigational Device Exemption (IDE) Study
• Actual Study Start Date: May 1, 2016
• Actual Primary Completion Date: Jan 12, 2017
• Actual Study Completion Date: Apr 11, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: 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	Device: Ellipse VR ICD and Durata/Optisure lead; Non-diagnostic MRI Scan sequence of head and chest

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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 exclusion criteria required by local law (e.g., age)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	John C. Lincoln North Mountain Hospital	Phoenix	Arizona	United States
2	Central Cardiology	Bakersfield	California	United States
3	Scripps Health	La Jolla	California	United States
4	Florida Hospital	Orlando	Florida	United States
5	Athens Regional Medical Center	Athens	Georgia	United States
6	Redmond Regional Medical Center	Rome	Georgia	United States
7	Prairie Education and Research Cooperative	Springfield	Illinois	United States
8	Parkview Research Center	Fort Wayne	Indiana	United States
9	Medical Consultants	Muncie	Indiana	United States
10	Massachusetts General Hospital	Boston	Massachusetts	United States
11	Sparrow Clinical Research Institute	Lansing	Michigan	United States
12	Providence Hospital	Southfield	Michigan	United States
13	Jackson Heart Clinic	Jackson	Mississippi	United States
14	St. Francis	Roslyn	New York	United States
15	The Cleveland Clinic Foundation	Cleveland	Ohio	United States
16	Samaritan Heart & Vascular Institute	Corvallis	Oregon	United States
17	Saint Vincent Consultants in Cardiovascular Diseases	Erie	Pennsylvania	United States
18	Pinnacle Health System	Harrisburg	Pennsylvania	United States
19	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States
20	Donald Guthrie Foundation for Education and Research	Sayre	Pennsylvania	United States
21	Methodist University Hospital	Memphis	Tennessee	United States
22	St. Thomas Hospital	Nashville	Tennessee	United States
23	Baylor All Saints Medical Center at Fort Worth	Fort Worth	Texas	United States
24	West Virginia University Hospital	Morgantown	West Virginia	United States
25	Aurora Medical Group	Milwaukee	Wisconsin	United States
26	Cardiac Rhythm Specialists, S.C.	Milwaukee	Wisconsin	United States
27	Semmelweis University	Budapest		Hungary
28	Szpital Kliniczny Premienienia Panskiego	Poznan	Silesia	Poland
29	American Heart of Poland SA	Tychy	Silesia	Poland
30	Carint Scanmed Sp. z.o.o.	Krakow	Voivode	Poland
31	Hospital Universitario de Salamanca	Salamanca	Castellon	Spain
32	Golden Jubilee National Hospital	Clydebank	West Dunbartonshire	United Kingdom

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Study Chair: Saman Nazarian, MD, Johns Hopkins University Hospital

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Jun 17, 2016

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT02787291
• Other Study ID Numbers: SJM-CIP-CRD768
• First Posted: Jun 1, 2016
• Last Update Posted: Sep 3, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No

Study Results

Participant Flow

Arm/Group Title	Ellipse VR ICD and Durata/Optisure Lead
Arm/Group Description	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
Period Title: Overall Study
STARTED	227
COMPLETED	227
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Ellipse VR ICD and Durata/Optisure Lead
Arm/Group Description	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 Participants	227
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.9 (11.2)
Sex: Female, Male (Count of Participants)
Female	41 18.1%
Male	186 81.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	20 8.8%
Not Hispanic or Latino	207 91.2%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	3 1.3%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	23 10.1%
White	201 88.5%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
Hungary	21 9.3%
United States	113 49.8%
Poland	64 28.2%
United Kingdom	11 4.8%
Spain	18 7.9%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With MRI Scan Related Complications
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Ellipse VR ICD and Durata/Optisure Lead
Arm/Group Description	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
Measure Participants	198
Count of Participants [Participants]	0 0%

2. Primary Outcome

Title	Percentage of Participants With Ventricular Capture Threshold ≤ to 0.5V
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Ellipse VR ICD and Durata/Optisure Lead
Arm/Group Description	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
Measure Participants	187
Count of Participants [Participants]	0 0%

3. Primary Outcome

Title	Percentage of Participants With Ventricular Sensing Amplitude Decrease of ≤ 50% From Pre-MRI Scan to 1 Month Post MRI Scan
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Ellipse VR ICD and Durata/Optisure Lead
Arm/Group Description	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
Measure Participants	198
Count of Participants [Participants]	0 0%

Adverse Events

Time Frame	1 month post MRI scan
Adverse Event Reporting Description	Protocol defined ADE (Adverse Device Effects), SADEs (Serious Adverse Device Effects), UADE (Unanticipated Adverse Device Effects), and USADEs (Unanticipated Serious Adverse Device Effects) were collected in this trial and were adjudicated by a Clinical Events Committee
Arm/Group Title	Ellipse VR ICD and Durata/Optisure Lead
Arm/Group Description	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
All Cause Mortality
	Ellipse VR ICD and Durata/Optisure Lead
	Affected / at Risk (%)	# Events
Total	2/227 (0.9%)
Serious Adverse Events
	Ellipse VR ICD and Durata/Optisure Lead
	Affected / at Risk (%)	# Events
Total	0/227 (0%)
Other (Not Including Serious) Adverse Events
	Ellipse VR ICD and Durata/Optisure Lead
	Affected / at Risk (%)	# Events
Total	0/227 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.