St.Jude Medical Cardiac Lead Assessment Study
- Conditions
- Externalized ConductorsVisual Lead AnomaliesElectrical Dysfunction
- Registration Number
- NCT01507987
- Lead Sponsor
- Abbott Medical Devices
- Brief Summary
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).
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2216
- Patient has a market released SJM Implantable Cardioverter Defibrillator (ICD), CRT-D or CRT-P already implanted.
- 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.)
- 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.
- Are 18 years or above
- Patient is currently pregnant.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 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
Number of Other Visual Lead Anomalies by Each Subcategory (Fracture, Kink, Subclavian Crush, Other Irregularities) 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.
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. 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
Number of Leads With Electrical Dysfunction 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.
Number of Leads With Externalized Conductors 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
The Annual Hazard Rate of Lead Electrical Dysfunction in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata Leads. 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.
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. 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
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. 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
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 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
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 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
- Secondary Outcome Measures
Name Time Method Estimation of Cumulative Lead Anomaly Events From Time of Detecting Externalized Conductors to Electrical Dysfunction, by Year of Initial Implant 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
Estimation of Cumulative Lead Anomaly Events From Time of Detecting Externalized Conductors to Clinical Intervention, by Year of Initial Implant 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.
Estimation of Lead Anomaly Events From Time of Other Visual Lead Anomalies by Each Subcategory to Clinical Intervention, by Year of Initial Implant 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
Number of Participants With an Adverse Event Through 30 Days Post-intervention for Lead (e.g. Extraction, Abandonment, Revision, Other). 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
Comparison of Number of Patients With Externalized Conductors to Number of Patients Without Externalized Conductors (EC) 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.
Comparison of Patients With Electrical Dysfunction to Those Without Electrical Dysfunction (ED). 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
Estimation of Cumulative Lead Anomaly Events From Time of Detecting Other Visual Lead Anomaly to Electrical Dysfunction, by Year of Initial Implant 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
Trial Locations
- Locations (45)
Ohio State University
🇺🇸Columbus, Ohio, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Wellspan Health
🇺🇸York, Pennsylvania, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University of Utah Hospital
🇺🇸Salt Lake City, Utah, United States
Providence Heart & Vascular Institute
🇺🇸Portland, Oregon, United States
Cardiology, P.C.
🇺🇸Birmingham, Alabama, United States
Heart Center Research
🇺🇸Huntsville, Alabama, United States
Arkansas Heart Hospital
🇺🇸Little Rock, Arkansas, United States
Kaiser Permanente Los Angeles Medical Center
🇺🇸Los Angeles, California, United States
University Hospital of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Arizona Arrhythmia Consultants
🇺🇸Scottsdale, Arizona, United States
Scripps Green Hospital
🇺🇸La Jolla, California, United States
Cardiac Rhythm Specialists
🇺🇸Reseda, California, United States
St. Joseph's Medical Center
🇺🇸Stockton, California, United States
Naples Heart Rhytm Specialists, PA
🇺🇸Naples, Florida, United States
Redmond Regional Medical Center
🇺🇸Rome, Georgia, United States
OSF Healthcare Cardiovascular Institute
🇺🇸Peoria, Illinois, United States
Mid-America Cardiology Associates, PC
🇺🇸Kansas City, Kansas, United States
Heart Clinic of Hammond, LLC
🇺🇸Hammond, Louisiana, United States
Sparrow Clinical Research Institute
🇺🇸Lansing, Michigan, United States
Jackson Heart Clinic
🇺🇸Jackson, Mississippi, United States
Cardiology Associates of North Mississippi
🇺🇸Tupelo, Mississippi, United States
Deborah Heart and Lung
🇺🇸Browns Mills, New Jersey, United States
Methodist Physicians Clinic-Heart Consultants
🇺🇸Omaha, Nebraska, United States
Asheville Cardiology Associates
🇺🇸Asheville, North Carolina, United States
Drexel University College oF Medicine
🇺🇸Philadelphia, Pennsylvania, United States
The Toledo Hospital
🇺🇸Toledo, Ohio, United States
Saint Vincent Consultants in Cardiovascular Diseases
🇺🇸Erie, Pennsylvania, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Donald Guthrie Foundation for Education and Research
🇺🇸Sayre, Pennsylvania, United States
Sutherland Cardiology Clinic
🇺🇸Germantown, Tennessee, United States
Mountain States Medical Group Cardiology
🇺🇸Johnson City, Tennessee, United States
South Texas Cardiovascular Consultants
🇺🇸San Antonio, Texas, United States
Arrhythmia Consultants
🇺🇸Memphis, Tennessee, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
Osaka City University Hospital
🇯🇵Osaka-shi, Osaka, Japan
Kyoto-Katsura Hospital
🇯🇵Kyoto, Japan
University of Tsukuba Hospital
🇯🇵Tsukuba, Ibaraki, Japan
Penrose St. Francis Health Services
🇺🇸Colorado Springs, Colorado, United States
QE II Health Sciences
🇨🇦Halifax, Nova Scotia, Canada
Mercy Medical Group
🇺🇸Sacramento, California, United States
Aurora Medical Group
🇺🇸Milwaukee, Wisconsin, United States
Ochsner Medical Center
🇺🇸New Orleans, Louisiana, United States
New Mexico Heart Institute
🇺🇸Albuquerque, New Mexico, United States