Electrical Dysfunction Clinical Trial
— CLASOfficial title:
St.Jude Medical Cardiac Lead Assessment Study
| Verified date | July 2021 |
| Source | Abbott Medical Devices |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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).
| Status | Completed |
| Enrollment | 2216 |
| Est. completion date | September 2019 |
| Est. primary completion date | June 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | QE II Health Sciences | Halifax | Nova Scotia |
| Japan | Kyoto-Katsura Hospital | Kyoto | |
| Japan | Osaka City University Hospital | Osaka-shi | Osaka |
| Japan | University of Tsukuba Hospital | Tsukuba | Ibaraki |
| United States | New Mexico Heart Institute | Albuquerque | New Mexico |
| United States | Asheville Cardiology Associates | Asheville | North Carolina |
| United States | Cardiology, P.C. | Birmingham | Alabama |
| United States | University Hospital of Alabama at Birmingham | Birmingham | Alabama |
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| United States | Deborah Heart and Lung | Browns Mills | New Jersey |
| United States | The Cleveland Clinic Foundation | Cleveland | Ohio |
| United States | Penrose St. Francis Health Services | Colorado Springs | Colorado |
| United States | Ohio State University | Columbus | Ohio |
| United States | Saint Vincent Consultants in Cardiovascular Diseases | Erie | Pennsylvania |
| United States | Sutherland Cardiology Clinic | Germantown | Tennessee |
| United States | Heart Clinic of Hammond, LLC | Hammond | Louisiana |
| United States | Heart Center Research | Huntsville | Alabama |
| United States | Jackson Heart Clinic | Jackson | Mississippi |
| United States | Mountain States Medical Group Cardiology | Johnson City | Tennessee |
| United States | Mid-America Cardiology Associates, PC | Kansas City | Kansas |
| United States | Scripps Green Hospital | La Jolla | California |
| United States | Sparrow Clinical Research Institute | Lansing | Michigan |
| United States | Arkansas Heart Hospital | Little Rock | Arkansas |
| United States | Kaiser Permanente Los Angeles Medical Center | Los Angeles | California |
| United States | Arrhythmia Consultants | Memphis | Tennessee |
| United States | Aurora Medical Group | Milwaukee | Wisconsin |
| United States | Naples Heart Rhytm Specialists, PA | Naples | Florida |
| United States | Ochsner Medical Center | New Orleans | Louisiana |
| United States | Sentara Norfolk General Hospital | Norfolk | Virginia |
| United States | Methodist Physicians Clinic-Heart Consultants | Omaha | Nebraska |
| United States | OSF Healthcare Cardiovascular Institute | Peoria | Illinois |
| United States | Drexel University College oF Medicine | Philadelphia | Pennsylvania |
| United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
| United States | Providence Heart & Vascular Institute | Portland | Oregon |
| United States | Cardiac Rhythm Specialists | Reseda | California |
| United States | Redmond Regional Medical Center | Rome | Georgia |
| United States | Mercy Medical Group | Sacramento | California |
| United States | University of Utah Hospital | Salt Lake City | Utah |
| United States | South Texas Cardiovascular Consultants | San Antonio | Texas |
| United States | Donald Guthrie Foundation for Education and Research | Sayre | Pennsylvania |
| United States | Arizona Arrhythmia Consultants | Scottsdale | Arizona |
| United States | St. Joseph's Medical Center | Stockton | California |
| United States | The Toledo Hospital | Toledo | Ohio |
| United States | Cardiology Associates of North Mississippi | Tupelo | Mississippi |
| United States | Wellspan Health | York | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Abbott Medical Devices |
United States, Canada, Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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. | This outcome is assessed at enrollment and over the course of 3 years of follow-up | |
| 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 | This outcome is assessed at enrollment | |
| 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. | This outcome is assessed at enrollment | |
| 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. | This outcome is assessed from enrollment through the course of 3 years of follow-up | |
| Primary | 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. | 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 | |
| Primary | 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. | 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 | |
| Primary | 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. | 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 | |
| Primary | 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 | 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 | |
| Primary | 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 | 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 | |
| Primary | 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 | 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 | Estimation of Cumulative Lead Anomaly Events From Time of Detecting Externalized Conductors to Electrical Dysfunction, by Year of Initial Implant | 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 | |
| Secondary | Estimation of Cumulative Lead Anomaly Events From Time of Detecting Other Visual Lead Anomaly to Electrical Dysfunction, by Year of Initial Implant | 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 | |
| Secondary | Number of Participants With an Adverse Event Through 30 Days Post-intervention for Lead (e.g. Extraction, Abandonment, Revision, Other). | 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 | |
| Secondary | Estimation of Cumulative Lead Anomaly Events From Time of Detecting Externalized Conductors to Clinical Intervention, by Year of Initial Implant | 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 | |
| Secondary | Estimation of Lead Anomaly Events From Time of Other Visual Lead Anomalies by Each Subcategory to Clinical Intervention, by Year of Initial Implant | 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 | |
| Secondary | Comparison of Number of Patients With Externalized Conductors to Number of Patients Without Externalized Conductors (EC) | 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 | |
| Secondary | Comparison of Patients With Electrical Dysfunction to Those Without Electrical Dysfunction (ED). | 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 |