N/A
Completed N=2,847
St.Jude Medical Cardiac Lead Assessment Study
Externalized Conductors · Visual Lead Anomalies · Electrical Dysfunction
Source: ClinicalTrials.gov NCT01507987 ↗
Enrolled (actual)
2,847
Serious AEs
2.9%
Results posted
Aug 2021
Primary outcomePrimary: Number of Leads With Electrical Dysfunction — 24; 27; 15; 2 implanted leads
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Leads With Electrical Dysfunction |
24; 27; 15; 2 | — |
| PRIMARY Number of Leads With Externalized Conductors |
0; 144; 44; 10 | — |
| PRIMARY Number of Other Visual Lead Anomalies by Each Subcategory (Fracture, Kink, Subclavian Crush, Other Irregularities) |
7; 19; 7; 4 | — |
| PRIMARY The Annual Hazard Rate of Lead Electrical Dysfunction in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata Leads. |
0.010; 0.019; 0.014; 0.001 | — |
| 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. |
0.0025; 0.0480; 0.0158; 0.0288 | — |
| 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. |
0.0015; 0.0897; 0.0234; 0.0087 | — |
| 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. |
0.0035; 0.0658; 0.0097; 0.0110 | — |
| 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 |
0.0025; 0.0108; 0.0117; 0.0053 | — |
| 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 |
0; 0.0027; 0.0070; 0.0021 | — |
| 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 |
0; 0.0066; 0; 0 | — |
| SECONDARY Estimation of Cumulative Lead Anomaly Events From Time of Detecting Externalized Conductors to Electrical Dysfunction, by Year of Initial Implant |
0; 0; 0; 1; 1; 3 | — |
| SECONDARY Estimation of Cumulative Lead Anomaly Events From Time of Detecting Other Visual Lead Anomaly to Electrical Dysfunction, by Year of Initial Implant |
0; 0; 0; 1; 0; 0 | — |
| SECONDARY Number of Participants With an Adverse Event Through 30 Days Post-intervention for Lead (e.g. Extraction, Abandonment, Revision, Other). |
1; 0; 0; 0; 0; 0 | — |
| SECONDARY Estimation of Cumulative Lead Anomaly Events From Time of Detecting Externalized Conductors to Clinical Intervention, by Year of Initial Implant |
0; 0; 0; 0; 0; 1 | — |
| SECONDARY Estimation of Lead Anomaly Events From Time of Other Visual Lead Anomalies by Each Subcategory to Clinical Intervention, by Year of Initial Implant |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Comparison of Number of Patients With Externalized Conductors to Number of Patients Without Externalized Conductors (EC) |
57; 395; 204; 456 | — |
| SECONDARY Comparison of Patients With Electrical Dysfunction to Those Without Electrical Dysfunction (ED). |
61.8; 67.2 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01507987). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.