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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02787291
Other study ID # SJM-CIP-CRD768
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2016
Est. completion date April 11, 2018

Study information

Verified date August 2020
Source Abbott Medical Devices
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 227
Est. completion date April 11, 2018
Est. primary completion date January 12, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Ellipse VR ICD and Durata/Optisure lead
Non-diagnostic MRI Scan sequence of head and chest

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Hungary,  Poland,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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