N/A
Completed N=2,499
Post Approval Registry of Corox OTW, Endocardial, Left Ventricular Steroid Lead, Bipolar
Source: ClinicalTrials.gov NCT00810264 ↗Enrolled (actual)
2,499
Serious AEs
11.2%
Results posted
Nov 2019
Primary outcomePrimary: Percentage of Subjects Who Are Free of Complications Related to the Corox LV Lead — 94.19 percentage of subjects — p=<0.0001
Summary
The objective of this study is to confirm the long-term safety and reliability of the Corox OTW BP left ventricular (LV) pacing lead. As a condition of approval, the FDA required that a registry documenting the post approval clinical experience of these leads be designed and implemented.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Who Are Free of Complications Related to the Corox LV Lead |
94.19 | <0.0001 sig |
| PRIMARY Percentage of Subjects Experiencing Individual Complications |
3.28; 1.90; 0.53; 0.11 | — |
| SECONDARY Mean Successful Biventricular Pacing in Subjects at the 5 Year In-office Visit. |
97.4 | — |
| SECONDARY Percentage of Subjects Experiencing Serious Adverse Event Excluded From Primary Safety Endpoint |
0.04; 0.96; 1.00; 1.64; 0.16; 0.28 | — |
| SECONDARY Corox BP LV Lead Pacing Threshold Measurements |
1.41 | — |
| SECONDARY Corox BP LV Lead Sensing Measurements |
13.94 | — |
| SECONDARY Corox BP LV Lead Impedance Measurements |
726.5 | — |
| SECONDARY Pacing Threshold Measurements Per Corox BP LV Lead Model |
1.30; 1.40; 1.53 | — |
| SECONDARY Sensing Measurements Per Corox BP LV Lead Model |
14.82; 13.94; 13.04 | — |
| SECONDARY Impedance Measurements Per Corox BP LV Lead Model |
730.3; 734.4; 709.2 | — |
| SECONDARY Overall Incidence of Primary Endpoint 1 Serious Adverse Events for Each Corox BP Lead Model |
7.17; 6.48; 3.38 | — |
| SECONDARY Incidence of Individual Types of Primary Endpoint 2 Adverse Events Will be Evaluated Separately for Each Corox BP Lead Model |
3.58; 3.49; 2.63; 1.79; 2.99; 0.38 | — |
Eligibility Criteria
Inclusion Criteria
- Successfully implanted BIOTRONIK CRT system, including a Corox BP LV lead, from 7-180 days prior to enrollment
- Able to understand the nature of the registry and give informed consent
- Available for follow-up visits on a regular basis at the investigational site
- Age greater than or equal to 18 years
Exclusion Criteria
- Enrolled in any IDE clinical study
- Planned cardiac surgical procedures or interventional measures within the next 6 months
- Expected to receive a heart transplant within 1 year
- Life expectancy less than 1 year
- Presence of another life-threatening, underlying illness separate from their cardiac disorder
- Pregnancy
- Inability to provide date of implant, devices implanted, age, gender, and whether the patient experienced any protocol-defined adverse events since implant
Data sourced from ClinicalTrials.gov (NCT00810264). 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.