Clinical trial NCT01507987: St.Jude Medical Cardiac Lead Assessment Study
Official title: St.Jude Medical Cardiac Lead Assessment Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Externalized Conductors
Visual Lead Anomalies
Electrical Dysfunction
Keywords: Externalized Conductors, visual lead an
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2012-01-11
Enrollment: 2216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Leads With Electrical Dysfunction
timeFrame: This outcome is assessed at enrollment and over the course of 3 years of follow-up
measure: Number of Leads With Externalized Conductors
timeFrame: This outcome is assessed at enrollment
measure: Number of Other Visual Lead Anomalies by Each Subcategory (Fracture, Kink, Subclavian Crush, Other Irregularities)
timeFrame: This outcome is assessed at enrollment
measure: The Annual Hazard Rate of Lead Electrical Dysfunction in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata Leads.
timeFrame: This outcome is assessed from enrollment through the course of 3 years of follow-up
measure: 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.
timeFrame: year 1 follow-up
measure: 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.
timeFrame: year 1 to year 2 follow-up
measure: 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.
timeFrame: year 2 to year 3 follow-up
measure: 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
timeFrame: This outcome is assessed from enrollment to year 1
measure: 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
timeFrame: This outcome is assessed from year 1 to year 2 of follow-up
measure: 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
timeFrame: This outcome is assessed from year 2 to year 3 follow-up
Secondary outcomes:
measure: Estimation of Cumulative Lead Anomaly Events From Time of Detecting Externalized Conductors to Electrical Dysfunction, by Year of Initial Implant
timeFrame: This outcome is assessed from time of detecting EC till the course of 3 years of follow-up
measure: Estimation of Cumulative Lead Anomaly Events From Time of Detecting Other Visual Lead Anomaly to Electrical Dysfunction, by Year of Initial Implant
timeFrame: This outcome is assessed from time of detecting other visual lead anomaly till the course of 3 years of follow-up
measure: Number of Participants With an Adverse Event Through 30 Days Post-intervention for Lead (e.g. Extraction, Abandonment, Revision, Other).
timeFrame: within 30 days associated with study lead related interventions
measure: Estimation of Cumulative Lead Anomaly Events From Time of Detecting Externalized Conductors to Clinical Intervention, by Year of Initial Implant
timeFrame: This outcome is assessed from time of detection of externalized conductor to 3 years follow-up
measure: Estimation of Lead Anomaly Events From Time of Other Visual Lead Anomalies by Each Subcategory to Clinical Intervention, by Year of Initial Implant
timeFrame: This outcome is assessed from time of detection of other visual lead anomaly until 3 years of follow-up
measure: Comparison of Number of Patients With Externalized Conductors to Number of Patients Without Externalized Conductors (EC)
timeFrame: This outcome is assessed from enrollment till the course of 3 years of follow-up
measure: Comparison of Patients With Electrical Dysfunction to Those Without Electrical Dysfunction (ED).
timeFrame: This outcome is assessed from enrollment till the course of 3 years of follow-up
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cardiology, P.C.
state: Alabama
city: Birmingham
country: United States
facility: University Hospital of Alabama at Birmingham
state: Alabama
city: Huntsville
country: United States
facility: Heart Center Research
state: Alabama
city: Scottsdale
country: United States
facility: Arizona Arrhythmia Consultants
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: La Jolla
country: United States
facility: Scripps Green Hospital
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente Los Angeles Medical Center
state: California
city: Reseda
country: United States
facility: Cardiac Rhythm Specialists
state: California
city: Sacramento
country: United States
facility: Mercy Medical Group
state: California
city: Stockton
country: United States
facility: St. Joseph's Medical Center
state: California
city: Colorado Springs
country: United States
facility: Penrose St. Francis Health Services
state: Colorado
city: Naples
country: United States
facility: Naples Heart Rhytm Specialists, PA
state: Florida
city: Rome
country: United States
facility: Redmond Regional Medical Center
state: Georgia
city: Peoria
country: United States
facility: OSF Healthcare Cardiovascular Institute
state: Illinois
city: Kansas City
country: United States
facility: Mid-America Cardiology Associates, PC
state: Kansas
city: Hammond
country: United States
facility: Heart Clinic of Hammond, LLC
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Lansing
country: United States
facility: Sparrow Clinical Research Institute
state: Michigan
city: Jackson
country: United States
facility: Jackson Heart Clinic
state: Mississippi
city: Tupelo
country: United States
facility: Cardiology Associates of North Mississippi
state: Mississippi
city: Omaha
country: United States
facility: Methodist Physicians Clinic-Heart Consultants
state: Nebraska
city: Browns Mills
country: United States
facility: Deborah Heart and Lung
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Heart Institute
state: New Mexico
city: Asheville
country: United States
facility: Asheville Cardiology Associates
state: North Carolina
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Toledo
country: United States
facility: The Toledo Hospital
state: Ohio
city: Portland
country: United States
facility: Providence Heart & Vascular Institute
state: Oregon
city: Erie
country: United States
facility: Saint Vincent Consultants in Cardiovascular Diseases
state: Pennsylvania
city: Philadelphia
country: United States
facility: Drexel University College oF Medicine
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Sayre
country: United States
facility: Donald Guthrie Foundation for Education and Research
state: Pennsylvania
city: York
country: United States
facility: Wellspan Health
state: Pennsylvania
city: Germantown
country: United States
facility: Sutherland Cardiology Clinic
state: Tennessee
city: Johnson City
country: United States
facility: Mountain States Medical Group Cardiology
state: Tennessee
city: Memphis
country: United States
facility: Arrhythmia Consultants
state: Tennessee
city: San Antonio
country: United States
facility: South Texas Cardiovascular Consultants
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Hospital
state: Utah
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Milwaukee
country: United States
facility: Aurora Medical Group
state: Wisconsin
city: Halifax
country: Canada
facility: QE II Health Sciences
state: Nova Scotia
city: Tsukuba
country: Japan
facility: University of Tsukuba Hospital
state: Ibaraki
city: Osaka-shi
country: Japan
facility: Osaka City University Hospital
state: Osaka
city: Kyoto
country: Japan
facility: Kyoto-Katsura Hospital
Study officials:
References: