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

Implantable Defibrillator User Clinical Trial

— MRI Ready IDE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02787291
• Other study ID #: SJM-CIP-CRD768
• Status: Completed
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Implantable Defibrillator User

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