Clinical trial NCT02787291: A Clinical Evaluation of the Durata or Optisure High Voltage Leads and Ellipse VR ICD Undergoing MRI, an IDE 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Implantable Defibrillator User
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2016-06-01
Enrollment: 227
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of Participants With MRI Scan Related Complications
timeFrame: MRI scan to 1 month post MRI scan
measure: Percentage of Participants With Ventricular Capture Threshold ≤ to 0.5V
timeFrame: pre-MRI scan to 1 month post MRI scan
measure: Percentage of Participants With Ventricular Sensing Amplitude Decrease of ≤ 50% From Pre-MRI Scan to 1 Month Post MRI Scan
timeFrame: pre-MRI scan to 1 month post MRI scan
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: John C. Lincoln North Mountain Hospital
state: Arizona
city: Bakersfield
country: United States
facility: Central Cardiology
state: California
city: La Jolla
country: United States
facility: Scripps Health
state: California
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Athens
country: United States
facility: Athens Regional Medical Center
state: Georgia
city: Rome
country: United States
facility: Redmond Regional Medical Center
state: Georgia
city: Springfield
country: United States
facility: Prairie Education and Research Cooperative
state: Illinois
city: Fort Wayne
country: United States
facility: Parkview Research Center
state: Indiana
city: Muncie
country: United States
facility: Medical Consultants
state: Indiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Lansing
country: United States
facility: Sparrow Clinical Research Institute
state: Michigan
city: Southfield
country: United States
facility: Providence Hospital
state: Michigan
city: Jackson
country: United States
facility: Jackson Heart Clinic
state: Mississippi
city: Roslyn
country: United States
facility: St. Francis
state: New York
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Corvallis
country: United States
facility: Samaritan Heart & Vascular Institute
state: Oregon
city: Erie
country: United States
facility: Saint Vincent Consultants in Cardiovascular Diseases
state: Pennsylvania
city: Harrisburg
country: United States
facility: Pinnacle Health System
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Sayre
country: United States
facility: Donald Guthrie Foundation for Education and Research
state: Pennsylvania
city: Memphis
country: United States
facility: Methodist University Hospital
state: Tennessee
city: Nashville
country: United States
facility: St. Thomas Hospital
state: Tennessee
city: Fort Worth
country: United States
facility: Baylor All Saints Medical Center at Fort Worth
state: Texas
city: Morgantown
country: United States
facility: West Virginia University Hospital
state: West Virginia
city: Milwaukee
country: United States
facility: Aurora Medical Group
state: Wisconsin
city: Milwaukee
country: United States
facility: Cardiac Rhythm Specialists, S.C.
state: Wisconsin
city: Budapest
country: Hungary
facility: Semmelweis University
city: Poznan
country: Poland
facility: Szpital Kliniczny Premienienia Panskiego
state: Silesia
city: Tychy
country: Poland
facility: American Heart of Poland SA
state: Silesia
city: Krakow
country: Poland
facility: Carint Scanmed Sp. z.o.o.
state: Voivode
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
state: Castellon
city: Clydebank
country: United Kingdom
facility: Golden Jubilee National Hospital
state: West Dunbartonshire
Study officials:
affiliation: Johns Hopkins University Hospital
name: Saman Nazarian, MD
role: STUDY_CHAIR
References:
citation: 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.