St.Jude Medical Cardiac Lead Assessment Study

Completed

Conditions studied: Externalized Conductors, Visual Lead Anomalies, Electrical Dysfunction

In brief

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).

Key facts

Study ID

NCT01507987

Run by

Abbott Medical Devices

People needed

2216

Starts

2013-03-01

Expected to finish

2019-09-01

Last updated by the study team

2021-08-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Penrose St. Francis Health Services — Colorado Springs, Colorado, 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
• Ochsner Medical Center — New Orleans, Louisiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, 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
• Methodist Physicians Clinic-Heart Consultants — Omaha, Nebraska, United States
• Deborah Heart and Lung — Browns Mills, New Jersey, United States
• New Mexico Heart Institute — Albuquerque, New Mexico, United States
• Asheville Cardiology Associates — Asheville, North Carolina, United States

Full record on ClinicalTrials.gov

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