Insulation Failure in St. Jude Riata Leads

February 7, 2017 updated by: Hartford Hospital

Insulation Failure in St. Jude Riata Leads: Screening and Predicting Impending Lead Failure

A recent study evaluated the Manufacturer and User Facility Device Experience (MAUDE) database, which contains reports of adverse events involving medical devices6,9. The FDA updates the database every two months. A total of 107 Riata leads with reported inside-out insulation breaks were found, of which 105 were available for analysis. The average age of the leads was 62.1+/-18.6 months. A total of 226 insulation defects were found with 143 inside-out insulation abrasions. Twenty-eight of the 105 leads (26.7%) had inside-out insulation defects underneath one or more of the high voltage-shocking coil. Of these, 23 were 8F and five were 7F Riata ST leads. Exposed cables or conductors were present in 32 leads and six leads had melted cables, presumably due to one or more high voltage shocks. 22 of the 43 leads assessed (51.2%) also had abraded ETFE cable coating exposing the conductor. Noise and other sensing issues were the most common signs of failure. Seven leads were found to have externalized cables and five exhibited electrical abnormalities. 31 patients (29.5%) experienced inappropriate shocks of which 41% had abraded cables.

A critical decision facing physicians is how to screen and manage patients who are found to have externalized cables. Externalized cables on fluoroscopy may precede any electrical abnormalities. Also noise may not be detected on all ICD models. A recent case report suggested that changes in lead parameters might be transient and may be missed. The lead may function normally as the high-voltage and pace-sense cables are covered with ETFE, which serves as the second insulating barrier. As this is a very thin layer (0.0015 inches) the reliability of this to withstand a high-energy shock is unknown. This may lead to failure of appropriate therapy for life threatening arrhythmias.

The aim of this study is to screen patients with ICD leads that potentially could have multiple different failure mechanisms, including inside-out insulation breaks, to develop a novel new algorithm and methods to detect these defects, thereby enabling physicians to prevent complications from failure of these leads.

It is hypothesized that current monitoring tools are insufficient for detecting the sometimes transient electrical failures of the Riata family of leads, and that additional device diagnostic information in combination with fluoroscopy may improve detection of electrical failures.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

A recent study evaluated the Manufacturer and User Facility Device Experience (MAUDE) database, which contains reports of adverse events involving medical devices6,9. The FDA updates the database every two months. A total of 107 Riata leads with reported inside-out insulation breaks were found, of which 105 were available for analysis. The average age of the leads was 62.1+/-18.6 months. A total of 226 insulation defects were found with 143 inside-out insulation abrasions. Twenty-eight of the 105 leads (26.7%) had inside-out insulation defects underneath one or more of the high voltage-shocking coil. Of these, 23 were 8F and five were 7F Riata ST leads. Exposed cables or conductors were present in 32 leads and six leads had melted cables, presumably due to one or more high voltage shocks. 22 of the 43 leads assessed (51.2%) also had abraded ETFE cable coating exposing the conductor. Noise and other sensing issues were the most common signs of failure. Seven leads were found to have externalized cables and five exhibited electrical abnormalities. 31 patients (29.5%) experienced inappropriate shocks of which 41% had abraded cables.

A critical decision facing physicians is how to screen and manage patients who are found to have externalized cables. Externalized cables on fluoroscopy may precede any electrical abnormalities. Also noise may not be detected on all ICD models. A recent case report suggested that changes in lead parameters might be transient and may be missed. The lead may function normally as the high-voltage and pace-sense cables are covered with ETFE, which serves as the second insulating barrier. As this is a very thin layer (0.0015 inches) the reliability of this to withstand a high-energy shock is unknown. This may lead to failure of appropriate therapy for life threatening arrhythmias.

The aim of this study is to screen patients with ICD leads that potentially could have multiple different failure mechanisms, including inside-out insulation breaks, to develop a novel new algorithm and methods to detect these defects, thereby enabling physicians to prevent complications from failure of these leads.

It is hypothesized that current monitoring tools are insufficient for detecting the sometimes transient electrical failures of the Riata family of leads, and that additional device diagnostic information in combination with fluoroscopy may improve detection of electrical failures.

This will be a prospective, single-center study. Patients who consent to participate will be enrolled for up to three years.

This study offers the potential of direct benefit to the patient and indirect benefit for future users of the ICD systems. This study may identify inside-out insulation breaks and prevent impending lead failure. Additionally, analyses of the data collected as part of this study may help to develop an "electronic footprint" or pattern to remotely identify inside-out insulation breaks in all ICD leads Potential risks include exposure to radiation from a fluoroscopic exam of the lead and receiving a synchronized ICD shock.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Recruiting
        • Hartford Hospital
        • Contact:
        • Principal Investigator:
          • Steven Zweibel, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female
  • Age ≥18
  • Implanted with any Medtronic Protecta® VR/DR/CRT, XT-VR/DR/CRT, Secura®, Virtuoso®, Maximo II®, Concerto® VR, Evera® or Viva® (and any future FDA-approved Medtronic ICD) device to which is attached a St. Jude Riata lead (Models 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, 1592, 7000, 7001, 7002, 7010, 7011, 7040, 7041, 7042)
  • Willing and able to sign informed consent

Exclusion Criteria:

  • Age <18
  • ICD that does not use a Riata lead
  • Riata lead not connected to Medtronic Protecta® VR/DR/CRT, XT-VR/DR/CRT, Maximo II® Secura®, Virtuoso®, Concerto® VR, Evera® or Viva® (and any future FDA-approved Medtronic ICD) device
  • Unwilling or unable to sign informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: participants
all subjects meeting inclusion and none of exclusion criteria
Procedure: fluoroscopy
Fluoroscopic evaluation of three different views (left anterior oblique, right anterior oblique and anterior/posterior) and magnification will be performed to check for externalized cables at 15 frames per second using the best visualized angle per screening electrophysiologist.
Procedure: synchronized high-voltage shock

If fluoroscopic evaluation shows externalized conductors or if patient is deemed high-risk, the patient will be consented for synchronized high voltage shock through his/her device. This will be done in the non-invasive electrophysiology lab with conscious sedation as is done during defibrillation threshold testing.

For patients undergoing a generator (ICD) change as part of standard of care, performance of synchronized, high-voltage shock will be performed at the discretion of the electrophysiologist.

Procedure: Holter monitor
Participants will be given a 24-hour Holter monitor at baseline and once annually, and will be followed at least every three months throughout the study. Participants who are found to have an electrical abnormality at any point during the study may be given a 24-hour Holter monitor if it is believed that this procedure will provide clinically useful information regarding the integrity of the lead.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
lead failure
Time Frame: 12-36 months post-enrollment
clinical and demographic data associated with lead failure will be evaluated after 12-36 months of subject participation
12-36 months post-enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hartford Hospital

Investigators

  • Principal Investigator: Steven Zweibel, MD, Hartford Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Anticipated)

April 1, 2018

Study Completion (Anticipated)

January 1, 2019

Study Registration Dates

First Submitted

January 28, 2014

First Submitted That Met QC Criteria

March 24, 2014

First Posted (Estimate)

March 26, 2014

Study Record Updates

Last Update Posted (Estimate)

February 8, 2017

Last Update Submitted That Met QC Criteria

February 7, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ZWEI003872

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on fluoroscopy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe