PatientsVille.com LogoPatientsVille.com

Externalized Conductors | St.Jude Medical Cardiac Lead Assessment Study

Externalized Conductors research study

What is the primary objective of this study?

The objectives of the study are: 1. To determine the prevalence of externalized conductors at enrollment in Riata®, Riata® ST Silicone, QuickSite®/QuickFlex® and Durata® leads 2. To determine the prevalence of other visual lead anomalies (fracture, subclavian crush, kink, broken filars on a shocking coil and other irregularities) by each subcategory at enrollment in Riata®, Riata® ST Silicone, QuickSite®/QuickFlex® and Durata® leads 3. To determine the prevalence of electrical dysfunction at enrollment in Riata®, Riata® ST Silicone, QuickSite®/QuickFlex® and Durata® leads 4. To determine the incidence of externalized conductors after enrollment in Riata®, Riata® ST Silicone, QuickSite®/QuickFlex® and Durata® leads 5. To determine the incidence of other visual lead anomalies by each subcategory after enrollment in Riata®, Riata® ST Silicone, QuickSite®/QuickFlex® and Durata® leads 6. To determine the incidence of electrical dysfunction after enrollment in Riata®, Riata® ST Silicone, QuickSite®/QuickFlex® and Durata® leads. 7. To evaluate the 30-day adverse event rate associated with lead revision procedures (include lead extractions or abandonments with or without lead replacement) in Riata®, Riata® ST Silicone, QuickSite®/QuickFlex®, and Durata® families of leads 8. To determine the prevalence of \"other insulation anomalies\" in \"returned leads\" for Riata®, Riata® ST Silicone, QuickSite®/QuickFlex®, and Durata® families of leads. \"Other insulation anomalies\" include any of the following: - Internal abrasion short under RV shock coil - Internal abrasion short under SVC shock coil - Exposed conductors defined as a breach of the outer insulation - Breach of the internal silicone lumen tubing, but the conductor cable is contained within the lead body diameter.

Who is eligible to participate?

Inclusion Criteria: 1. Patient has a market released SJM 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. 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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Externalized Conductors

Visual Lead Anomalies

Electrical Dysfunction

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Study Status

Active, not recruiting

Start Date: March 2013

Completed Date: March 2020

Phase:

Type: Observational

Design:

Primary Outcome: The prevalence of electrical dysfunction in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata leads.

Secondary Outcome: Time from enrollment to externalized conductors by year of initial implant

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: St. Jude Medical

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01507987

Discuss Bengay