N/A
Completed N=81
SecuraTM ICD Clinical Evaluation Study
Tachyarrhythmias
Source: ClinicalTrials.gov NCT00526227 ↗
Enrolled (actual)
81
Serious AEs
—
Results posted
Jun 2009
Primary outcomePrimary: Freedom From Unanticipated Serious Adverse Device Effects at 1-month Post Implant. — 0 percentage of patients
Summary
The purpose of the Secura clinical study is to evaluate the overall system safety and clinical performance of the Secura DR Implantable Cardioverter Defibrillator (ICD)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Freedom From Unanticipated Serious Adverse Device Effects at 1-month Post Implant. |
— | — |
| SECONDARY System Performance Assessed by Holter Records |
— | — |
| SECONDARY Adverse Events |
62 | — |
| SECONDARY System Performance Assessed by Save to Disk Files |
— | — |
| SECONDARY System Performance Assessed by Technical Observations |
— | — |
Eligibility Criteria
Inclusion Criteria
- Patients who have an ICD indication.
- Patients who are geographically stable and available for follow-up at the study center for the duration of the study.
- Patients who have signed a Medical Ethics Committee (MEC) approved Informed Consent form.
Exclusion Criteria
- Patients with a life expectancy less than the duration of the study.
- Patients with medical conditions that preclude the testing required for all patients by the study protocol or that otherwise limit study participation required for all patients.
- Patients with mechanical tricuspid heart valves.
Data sourced from ClinicalTrials.gov (NCT00526227). 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.