St.Jude Medical Cardiac Lead Assessment Study (CLAS)

July 29, 2021 updated by: Abbott Medical Devices
The Cardiac Lead Assessment Study (CLAS) is designed as a prospective, non-randomized, multi-center, international postmarket surveillance study under 522 Order PS120111 (August 16, 2012).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The objective of this study was to determine the prevalence and incidence of externalized conductors and other visual lead anomalies (as evidenced by imaging) and the risk of progression to electrical dysfunction in subjects with one or more of the following St. Jude Medical (SJM) cardiac leads: Riata leads, Riata ST leads, Durata and/or QuickSite/QuickFlex Cardiac Resynchronization Therapy (CRT) leads.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2216

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

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • QE II Health Sciences
  • Japan
      • Kyoto, Japan, 615 8256
        • Kyoto-Katsura Hospital
    • Ibaraki
      • Tsukuba, Ibaraki, Japan, 305-8576
        • University of Tsukuba Hospital
    • Osaka
      • Osaka-shi, Osaka, Japan, 545-8565
        • Osaka City University Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35211
        • Cardiology, P.C.
      • Birmingham, Alabama, United States, 35249
        • University Hospital of Alabama at Birmingham
      • Huntsville, Alabama, United States, 35801
        • Heart Center Research
    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • Arizona Arrhythmia Consultants
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Arkansas Heart Hospital
    • California
      • La Jolla, California, United States, 92037
        • Scripps Green Hospital
      • Los Angeles, California, United States, 90027
        • Kaiser Permanente Los Angeles Medical Center
      • Reseda, California, United States, 91335
        • Cardiac Rhythm Specialists
      • Sacramento, California, United States, 95819
        • Mercy Medical Group
      • Stockton, California, United States, 95204
        • St. Joseph's Medical Center
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Penrose St. Francis Health Services
    • Florida
      • Naples, Florida, United States, 34119
        • Naples Heart Rhytm Specialists, PA
    • Georgia
      • Rome, Georgia, United States, 30165
        • Redmond Regional Medical Center
    • Illinois
      • Peoria, Illinois, United States, 61614
        • OSF HealthCare Cardiovascular Institute
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Mid-America Cardiology Associates, PC
    • Louisiana
      • Hammond, Louisiana, United States, 70403
        • Heart Clinic of Hammond, LLC
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Lansing, Michigan, United States, 48912
        • Sparrow Clinical Research Institute
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Jackson Heart Clinic
      • Tupelo, Mississippi, United States, 38801
        • Cardiology Associates of North Mississippi
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Methodist Physicians Clinic-Heart Consultants
    • New Jersey
      • Browns Mills, New Jersey, United States, 08015
        • Deborah Heart and Lung
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • New Mexico Heart Institute
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Asheville Cardiology Associates
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43210
        • Ohio State University
      • Toledo, Ohio, United States, 43606
        • The Toledo Hospital
    • Oregon
      • Portland, Oregon, United States, 97225
        • Providence Heart & Vascular Institute
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16502
        • Saint Vincent Consultants in Cardiovascular Diseases
      • Philadelphia, Pennsylvania, United States, 19102
        • Drexel University College of Medicine
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
      • Sayre, Pennsylvania, United States, 18840
        • Donald Guthrie Foundation for Education and Research
      • York, Pennsylvania, United States, 17403
        • WellSpan Health
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Sutherland Cardiology Clinic
      • Johnson City, Tennessee, United States, 37601
        • Mountain States Medical Group Cardiology
      • Memphis, Tennessee, United States, 38104
        • Arrhythmia Consultants
    • Texas
      • San Antonio, Texas, United States, 78201
        • South Texas Cardiovascular Consultants
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Hospital
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Sentara Norfolk General Hospital
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora Medical Group

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients that have a market released St. Jude Medical Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy - Defibrillator (CRT-D) already implanted and also have at least one market released Riata/ Riata ST/QuickSite/QuickFlex/Durata already implanted.

Description

Inclusion Criteria:

  1. Patient has a market released SJM Implantable Cardioverter Defibrillator (ICD), CRT-D or CRT-P already implanted.
  2. Patient has at least one market released Riata/ Riata ST/QuickSite/QuickFlex/Durata already implanted in which the lead model number and lead implant date is indicated in Table 1 (see protocol attached.)
  3. Have the ability to provide informed consent for study participation and be willing to comply with the prescribed evaluations as detailed in this study plan.
  4. Are 18 years or above

Exclusion Criteria:

  1. Patient is currently pregnant.
  2. Enrolled or intend to participate in a clinical drug and/or device study, which could confound the results of this trial as determined by SJM, during the course of this clinical study

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients with SJM leads implanted
Patient has at least one market released Riata, Riata ST, QuickSite/QuickFlex, or Durata lead implanted
Device: Implanted with one or more of the following SJM leads: Riata leads, RiataST leads, Durata leads, and QuickSite/QuickFlex leads

Riata leads implanted between 2002-2009 Riata ST leads implanted between 2006-2009 Quicksite or QuickFlex leads implanted between 2006-2010 Durata leads implanted between 2008-2010

Subjects were followed for three years and cinefluoroscopy imaging was done annually to determine prevalence of externalized conductors or other visual lead anomalies

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Leads With Electrical Dysfunction
Time Frame: This outcome is assessed at enrollment and over the course of 3 years of follow-up
The prevalence of electrical dysfunction was calculated as the number of leads that have electrical dysfunction through three years of follow-up for the 4 lead groups divided by total number of leads in enrolled patients in each of the 4 lead groups.
This outcome is assessed at enrollment and over the course of 3 years of follow-up
Number of Leads With Externalized Conductors
Time Frame: This outcome is assessed at enrollment
The prevalence of externalized conductors was calculated as the number of leads that have been shown to have externalized conductors by imaging at the time of enrollment in each of the 4 lead groups divided by total number of leads in enrolled patients in each of the 4 lead groups
This outcome is assessed at enrollment
Number of Other Visual Lead Anomalies by Each Subcategory (Fracture, Kink, Subclavian Crush, Other Irregularities)
Time Frame: This outcome is assessed at enrollment
The prevalence of other visual lead anomalies (by each subcategory) was calculated as the number of leads that have been shown to have other visual anomaly (by each subcategory) at the time of enrollment in each of the 4 lead groups divided by total number of leads in enrolled patients in each of the 4 lead groups.
This outcome is assessed at enrollment
The Annual Hazard Rate of Lead Electrical Dysfunction in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata Leads.
Time Frame: This outcome is assessed from enrollment through the course of 3 years of follow-up
Annual hazard rate is the proportion of number of leads with electrical dysfunction to the total number of lead follow-up years.
This outcome is assessed from enrollment through the course of 3 years of follow-up
The Annual Hazard Rate of New Cases of Externalized Conductors (From Enrollment to Year 1) in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata Leads.
Time Frame: year 1 follow-up
Annual hazard rate calculated as ratio of all leads that are adjudicated by the committee and a have definite outcome of presence of externalized conductors to total follow-up years from enrollment to year 1
year 1 follow-up
The Annual Hazard Rate of New Cases of Externalized Conductors (From Year 1 to Year 2) in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata Leads.
Time Frame: year 1 to year 2 follow-up
Annual hazard rate calculated as ratio of all leads that are adjudicated by the committee and a have definite outcome of presence of externalized conductors to total follow-up years from year 1 to year 2
year 1 to year 2 follow-up
The Annual Hazard Rate of New Cases of Externalized Conductors (From Year 2 to Year 3) in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata Leads.
Time Frame: year 2 to year 3 follow-up
Annual hazard rate calculated as ratio of all leads that are adjudicated by the committee and a have definite outcome of presence of externalized conductors to total follow-up years from year 2 to year 3
year 2 to year 3 follow-up
The Annual Hazard Rate of New Cases of Other Visual Lead Anomalies by Each Subcategory (From Enrollment to Year 1) in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata Leads
Time Frame: This outcome is assessed from enrollment to year 1
Annual hazard rate calculated as proportion of leads adjudicated by the committee and a have definite outcome of presence of other visual lead anomaly to total follow up years from enrollment to year 1
This outcome is assessed from enrollment to year 1
The Annual Hazard Rate of New Cases of Other Visual Lead Anomalies by Each Subcategory (From Year 1 to Year 2) in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata Leads
Time Frame: This outcome is assessed from year 1 to year 2 of follow-up
Annual hazard rate calculated as proportion of leads adjudicated by the committee and a have definite outcome of presence of other visual lead anomaly to total follow up years from year 1 to year 2
This outcome is assessed from year 1 to year 2 of follow-up
The Annual Hazard Rate of New Cases of Other Visual Lead Anomalies by Each Subcategory (From Year 2 to Year 3) in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata Leads
Time Frame: This outcome is assessed from year 2 to year 3 follow-up
Annual hazard rate calculated as proportion of leads adjudicated by the committee and a have definite outcome of presence of other visual lead anomaly to total follow up years from year 2 to year 3
This outcome is assessed from year 2 to year 3 follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Estimation of Cumulative Lead Anomaly Events From Time of Detecting Externalized Conductors to Electrical Dysfunction, by Year of Initial Implant
Time Frame: This outcome is assessed from time of detecting EC till the course of 3 years of follow-up
Kaplan-Meier analysis of time from externalized conductors (EC) to electrical dysfunction, by year of initial implant. Count of cumulative lead anomaly events from time of detecting EC
This outcome is assessed from time of detecting EC till the course of 3 years of follow-up
Estimation of Cumulative Lead Anomaly Events From Time of Detecting Other Visual Lead Anomaly to Electrical Dysfunction, by Year of Initial Implant
Time Frame: This outcome is assessed from time of detecting other visual lead anomaly till the course of 3 years of follow-up
Kaplan-Meier analysis of time from other visual lead anomaly to electrical dysfunction, by year of initial implant. Count of cumulative lead anomaly events from time of detecting other visual lead anomaly
This outcome is assessed from time of detecting other visual lead anomaly till the course of 3 years of follow-up
Number of Participants With an Adverse Event Through 30 Days Post-intervention for Lead (e.g. Extraction, Abandonment, Revision, Other).
Time Frame: within 30 days associated with study lead related interventions
Number of participants with adverse events within 30 days associated with study lead related interventions for each lead group
within 30 days associated with study lead related interventions
Estimation of Cumulative Lead Anomaly Events From Time of Detecting Externalized Conductors to Clinical Intervention, by Year of Initial Implant
Time Frame: This outcome is assessed from time of detection of externalized conductor to 3 years follow-up
time from externalized conductors to clinical intervention for all lead subgroups.
This outcome is assessed from time of detection of externalized conductor to 3 years follow-up
Estimation of Lead Anomaly Events From Time of Other Visual Lead Anomalies by Each Subcategory to Clinical Intervention, by Year of Initial Implant
Time Frame: This outcome is assessed from time of detection of other visual lead anomaly until 3 years of follow-up
Kaplan-Meier analysis of time from visual lead anomalies for all lead and lead age subcategories to clinical intervention
This outcome is assessed from time of detection of other visual lead anomaly until 3 years of follow-up
Comparison of Number of Patients With Externalized Conductors to Number of Patients Without Externalized Conductors (EC)
Time Frame: This outcome is assessed from enrollment till the course of 3 years of follow-up
Comparison of patients with EC to those without EC: lead size effect on number of patients with or without EC (7F and 8F are lead sizes, F = French). Riata leads have 8F diameter and Riata ST leads have 7F diameter. The Riata/Riata ST families of leads were used for this comparison only to determine whether the difference in lead size (with the silicon material and other lead design factors controlled for) had an effect on externalization of conductors.
This outcome is assessed from enrollment till the course of 3 years of follow-up
Comparison of Patients With Electrical Dysfunction to Those Without Electrical Dysfunction (ED).
Time Frame: This outcome is assessed from enrollment till the course of 3 years of follow-up
Comparison of patients with ED to those without ED: subject age effect on ED
This outcome is assessed from enrollment till the course of 3 years of follow-up

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Medical Devices

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 (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 6, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2012

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 23, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 60039775/K
  • CRD-619 (OTHER: St. Jude Medical)

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.

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