St.Jude Medical Cardiac Lead Assessment Study (CLAS)

Abbott

Status

Completed

Conditions

Electrical Dysfunction

Visual Lead Anomalies

Externalized Conductors

Treatments

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

Study type

Observational

Funder types

Industry

Identifiers

NCT01507987

60039775/K

CRD-619 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment

2,216 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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