N/A
N=81
SecuraTM ICD Clinical Evaluation Study
Tachyarrhythmias
Bottom Line
View on ClinicalTrials.gov: NCT00526227 ↗Enrolled (actual)
81
Serious AEs
—
Results posted
Jun 2009
Primary outcome: Primary: Freedom From Unanticipated Serious Adverse Device Effects at 1-month Post Implant. — 0 percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Secura ICD (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Primary completion
- Dec 2007
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 |
— | — |
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)
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.