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

NCT02787291 | Completed Results DMC

• 1 other identifier: SJM-CIP-CRD768
• Study Type: interventional
• Target: 227
• Locations: 5 countries
• Sites: 32

Brief Summary

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

Conditions

Implantable Defibrillator User

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  pre-MRI scan to 1 month post MRI scan

Study Arms (1)

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

Device: Ellipse VR ICD and Durata/Optisure lead

Interventions

Ellipse VR ICD and Durata/Optisure lead DEVICE

Non-diagnostic MRI Scan sequence of head and chest

Ellipse VR ICD and Durata/Optisure lead

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (32)

John C. Lincoln North Mountain Hospital

Phoenix, Arizona, United States

Location

Central Cardiology

Bakersfield, California, United States

Location

Scripps Health

La Jolla, California, United States

Location

Florida Hospital

Orlando, Florida, United States

Location

Athens Regional Medical Center

Athens, Georgia, United States

Location

Redmond Regional Medical Center

Rome, Georgia, United States

Location

Prairie Education and Research Cooperative

Springfield, Illinois, United States

Location

Parkview Research Center

Fort Wayne, Indiana, United States

Location

Medical Consultants

Muncie, Indiana, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, United States

Location

Sparrow Clinical Research Institute

Lansing, Michigan, United States

Location

Providence Hospital

Southfield, Michigan, United States

Location

Jackson Heart Clinic

Jackson, Mississippi, United States

Location

St. Francis

Roslyn, New York, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Location

Samaritan Heart & Vascular Institute

Corvallis, Oregon, United States

Location

Saint Vincent Consultants in Cardiovascular Diseases

Erie, Pennsylvania, United States

Location

Pinnacle Health System

Harrisburg, Pennsylvania, United States

Location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Location

Donald Guthrie Foundation for Education and Research

Sayre, Pennsylvania, United States

Location

Methodist University Hospital

Memphis, Tennessee, United States

Location

St. Thomas Hospital

Nashville, Tennessee, United States

Location

Baylor All Saints Medical Center at Fort Worth

Fort Worth, Texas, United States

Location

West Virginia University Hospital

Morgantown, West Virginia, United States

Location

Aurora Medical Group

Milwaukee, Wisconsin, United States

Location

Cardiac Rhythm Specialists, S.C.

Milwaukee, Wisconsin, United States

Location

Semmelweis University

Budapest, Hungary

Location

Szpital Kliniczny Premienienia Panskiego

Poznan, Silesian Voivodeship, Poland

Location

American Heart of Poland SA

Tychy, Silesian Voivodeship, Poland

Location

Carint Scanmed Sp. z.o.o.

Krakow, Voivode, Poland

Location

Hospital Universitario de Salamanca

Salamanca, Castellon, Spain

Location

Golden Jubilee National Hospital

Clydebank, West Dunbartonshire, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 31439295 DERIVED

Results Point of Contact

• Title: Dr. Adam Cline- Clinical Scientist
• Organization: Abbott CAHF CRM

adam.cline@abbott.com

818-493-2025

Study Officials

• Saman Nazarian, MD

  Johns Hopkins University Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2016
• First Posted: June 1, 2016
• Study Start: May 1, 2016
• Primary Completion: January 12, 2017
• Study Completion: April 11, 2018
• Last Updated: September 3, 2020
• Results First Posted: September 3, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (26); PL (3); HU (1); GB (1); ES (1)