St.Jude Medical Cardiac Lead Assessment Study

NCT01507987•Abbott Medical Devices

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

Age

18 - No limit years

Sex

ALL

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

Locations (45)

Cardiology, P.C.

Birmingham, Alabama, United States

University Hospital of Alabama at Birmingham

Birmingham, Alabama, United States

Heart Center Research

Huntsville, Alabama, United States

Arizona Arrhythmia Consultants

Scottsdale, Arizona, United States

Arkansas Heart Hospital

Little Rock, Arkansas, United States

Scripps Green Hospital

La Jolla, California, United States

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Cardiac Rhythm Specialists

Reseda, California, United States

Mercy Medical Group

Sacramento, California, United States

St. Joseph's Medical Center

Stockton, California, United States

Key Dates

Start Date

March 1, 2013

Primary Completion Date

June 1, 2019

Completion Date

September 1, 2019

Last Updated

August 23, 2021

Enrollment

2,216

ACTUAL participants

Conditions

Externalized ConductorsVisual Lead AnomaliesElectrical Dysfunction

Interventions

Implanted with one or more of the following SJM leads: Riata leads, RiataST leads, Durata leads, and QuickSite/QuickFlex leads

DEVICE