Implantable Defibrillator UserMRI Ready IDENCT02787291
A Clinical Evaluation of the Durata or Optisure High Voltage Leads and Ellipse VR ICD Undergoing MRI, an IDE Study
A study testing Ellipse VR ICD and Durata/Optisure lead in people with Implantable Defibrillator User, run by Abbott Medical Devices at 32 sites in 5 countries.
Trial summary
To demonstrate safety and efficacy of the Durata or Optisure high voltage lead and Ellipse VR ICD in an MRI environment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Implantable Defibrillator User
- What is being tested?
- Ellipse VR ICD and Durata/Optisure lead
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 227 participants
- Where
- 32 sitesin 5 countries
- Study dates
- May 2016to 11 Apr 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Show all 9Show fewer
- 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)
Trial locations and contacts
32 sites in 5 countries.
32 sites in 5 countries
United States26 sites
Athens Regional Medical Center
Athens, Georgia
Central Cardiology
Bakersfield, California
Massachusetts General Hospital
Boston, Massachusetts
The Cleveland Clinic Foundation
Cleveland, Ohio
Samaritan Heart & Vascular Institute
Corvallis, Oregon
Saint Vincent Consultants in Cardiovascular Diseases
Erie, Pennsylvania
Parkview Research Center
Fort Wayne, Indiana
Baylor All Saints Medical Center at Fort Worth
Fort Worth, Texas
Pinnacle Health System
Harrisburg, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania
Jackson Heart Clinic
Jackson, Mississippi
Scripps Health
La Jolla, California
Sparrow Clinical Research Institute
Lansing, Michigan
Methodist University Hospital
Memphis, Tennessee
Aurora Medical Group
Milwaukee, Wisconsin
Cardiac Rhythm Specialists, S.C.
Milwaukee, Wisconsin
West Virginia University Hospital
Morgantown, West Virginia
Medical Consultants
Muncie, Indiana
St. Thomas Hospital
Nashville, Tennessee
Florida Hospital
Orlando, Florida
John C. Lincoln North Mountain Hospital
Phoenix, Arizona
Redmond Regional Medical Center
Rome, Georgia
St. Francis
Roslyn, New York
Donald Guthrie Foundation for Education and Research
Sayre, Pennsylvania
Providence Hospital
Southfield, Michigan
Prairie Education and Research Cooperative
Springfield, Illinois
Poland3 sites
Carint Scanmed Sp. z.o.o.
Krakow, Voivode
Szpital Kliniczny Premienienia Panskiego
Poznan, Silesian Voivodeship
American Heart of Poland SA
Tychy, Silesian Voivodeship
United Kingdom1 site
Golden Jubilee National Hospital
Clydebank, West Dunbartonshire
About this study
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
To demonstrate safety and efficacy of the Durata or Optisure high voltage lead and Ellipse VR ICD in an MRI environment.
Read the 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.
- Conditions
- Implantable Defibrillator User
- Being tested
- Ellipse VR ICD and Durata/Optisure lead
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ellipse VR ICD and Durata/Optisure leadDevice
Non-diagnostic MRI Scan sequence of head and chest
| Study group | Role | What they receive |
|---|---|---|
| Ellipse VR ICD and Durata/Optisure lead | Other | 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 Receives: Device: Ellipse VR ICD and Durata/Optisure lead |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: MRI scan to 1 month post MRI scan
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.
Measured: 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
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.
Measured: pre-MRI scan to 1 month post MRI scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study startMay 2016
- Primary completion12 Jan 2017
- Study completion11 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Implantable Defibrillator UserStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Saman Nazarian, MD, Study chair, Johns Hopkins University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02787291
- Sponsor's protocol ID
- SJM-CIP-CRD768
- Acronym
- MRI Ready IDE
- Status last verified
- Aug 2020
- First submitted
- 20 May 2016
- Last updated
- 3 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Nazarian S, Cantillon DJ, Woodard PK, Mela T, Cline AM, Strickberger AS; MRI Ready Investigators. MRI Safety for Patients Implanted With the MRI Ready ICD System: MRI Ready Study Results. JACC Clin Electrophysiol. 2019 Aug;5(8):935-943. doi: 10.1016/j.jacep.2019.05.010. Epub 2019 Jun 26.
PubMed 31439295
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02787291
- Acronym / sponsor ID
- MRI Ready IDE / SJM-CIP-CRD768
- Conditions
- Implantable Defibrillator User
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- May 2016 (actual)
- Primary completion
- 12 Jan 2017 (actual)
- Study completion
- 11 Apr 2018 (actual)
- First posted
- 1 Jun 2016 (estimated)
- Results
- Posted 3 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ellipse VR ICD and Durata/Optisure lead | Other | Device: Ellipse VR ICD and Durata/Optisure leadPts 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ellipse VR ICD and Durata/Optisure leadNon-diagnostic MRI Scan sequence of head and chest | Device | Ellipse VR ICD and Durata/Optisure lead |
Primary outcome
Number of Participants With MRI Scan Related Complications
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31439295Nazarian S, Cantillon DJ, Woodard PK, Mela T, Cline AM, Strickberger AS; MRI Ready Investigators. MRI Safety for Patients Implanted With the MRI Ready ICD System: MRI Ready Study Results. JACC Clin Electrophysiol. 2019 Aug;5(8):935-943. doi: 10.1016/j.jacep.2019.05.010. Epub 2019 Jun 26.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saman Nazarian, MD study chair
Johns Hopkins University Hospital
32 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ellipse VR ICD and Durata/Optisure lead in people with Implantable Defibrillator User, run by Abbott Medical Devices at 32 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Poland, Hungary, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With MRI Scan Related Complications (time frame: MRI scan to 1 month post MRI scan). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02787291, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2020; AzTrials last refreshed its copy on 7 Nov 2026.