St.Jude Medical Cardiac Lead Assessment Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01507987

Acronym

CLAS

Enrollment

2216

Registered

2012-01-11

Start date

2013-03-31

Completion date

2019-09-30

Last updated

2021-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Electrical Dysfunction, Externalized Conductors, Visual Lead Anomalies

Keywords

Externalized Conductors, visual lead an

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.

Interventions

DEVICEImplanted 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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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
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 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 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
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 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
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

Measure	Time frame	Description
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 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
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
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
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

Countries

Canada, Japan, United States

Participant flow

Recruitment details

The study enrolled a total of 2,216 subjects at 45 sites to achieve an evaluable sample size of at least 1,401 subjects. The first subject enrolled in this study on March 20, 2013 and enrollment was completed in June, 2016 with the last follow-up completed in June 13 2019.

Pre-assignment details

A subject that has at least one market released lead implanted was eligible for enrollment in the study. Subjects could have more than one study lead implanted. Each lead group was considered separately for independent analyses.

Participants by arm

Arm	Count
All Subjects Enrolled in the Study Demographics for all enrolled patients (N=2216)	2,216
Total	2,216

Baseline characteristics

Characteristic	All Subjects Enrolled in the Study
Age, Continuous	67 years STANDARD_DEVIATION 12
Ethnicity (NIH/OMB) Hispanic or Latino	56 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2158 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants
Race (NIH/OMB) American Indian or Alaska Native	8 Participants
Race (NIH/OMB) Asian	91 Participants
Race (NIH/OMB) Black or African American	335 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants
Race (NIH/OMB) White	1770 Participants
Region of Enrollment Canada	48 participants
Region of Enrollment Japan	83 participants
Region of Enrollment United States	2085 participants
Sex: Female, Male Female	600 Participants
Sex: Female, Male Male	1616 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	130 / 982	111 / 670	64 / 458	135 / 737
other Total, other adverse events	20 / 982	14 / 670	9 / 458	11 / 737
serious Total, serious adverse events	26 / 982	28 / 670	22 / 458	7 / 737

Outcome results

Primary

Number of Leads With Electrical Dysfunction

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.

Time frame: This outcome is assessed at enrollment and over the course of 3 years of follow-up

Population: All SJM leads enrolled in the study with Durata, Riata, Riata ST, or QuickSite/QuickFlex leads

Arm	Measure	Value (COUNT_OF_UNITS)
Durata Leads	Number of Leads With Electrical Dysfunction	24 implanted leads
Riata Leads	Number of Leads With Electrical Dysfunction	27 implanted leads
Riata ST	Number of Leads With Electrical Dysfunction	15 implanted leads
QuickSite/QuickFlex	Number of Leads With Electrical Dysfunction	2 implanted leads

Primary

Number of Leads With Externalized Conductors

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

Time frame: This outcome is assessed at enrollment

Population: All SJM leads enrolled in the study with Durata, Riata, Riata ST, or QuickSite/QuickFlex leads

Arm	Measure	Value (COUNT_OF_UNITS)
Durata Leads	Number of Leads With Externalized Conductors	0 implanted leads
Riata Leads	Number of Leads With Externalized Conductors	144 implanted leads
Riata ST	Number of Leads With Externalized Conductors	44 implanted leads
QuickSite/QuickFlex	Number of Leads With Externalized Conductors	10 implanted leads

Primary

Number of Other Visual Lead Anomalies by Each Subcategory (Fracture, Kink, Subclavian Crush, Other Irregularities)

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.

Time frame: This outcome is assessed at enrollment

Arm	Measure	Value (COUNT_OF_UNITS)
Durata Leads	Number of Other Visual Lead Anomalies by Each Subcategory (Fracture, Kink, Subclavian Crush, Other Irregularities)	7 implanted leads
Riata Leads	Number of Other Visual Lead Anomalies by Each Subcategory (Fracture, Kink, Subclavian Crush, Other Irregularities)	19 implanted leads
Riata ST	Number of Other Visual Lead Anomalies by Each Subcategory (Fracture, Kink, Subclavian Crush, Other Irregularities)	7 implanted leads
QuickSite/QuickFlex	Number of Other Visual Lead Anomalies by Each Subcategory (Fracture, Kink, Subclavian Crush, Other Irregularities)	4 implanted leads

Primary

The Annual Hazard Rate of Lead Electrical Dysfunction in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata Leads.

Annual hazard rate is the proportion of number of leads with electrical dysfunction to the total number of lead follow-up years.

Time frame: This outcome is assessed from enrollment through the course of 3 years of follow-up