Clinical trial NCT00526227: SecuraTM ICD Clinical Evaluation Study
Official title: Clinical Study to Evaluate System Safety and Clinical Performance of the SecuraTM ICD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tachyarrhythmias
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2007-09-10
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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)

Detailed description: The Secura ICD is an investigational dual chamber ICD that provides atrial and ventricular tachyarrhythmia detection and therapy, cardioversion, defibrillation, dual chamber rate-responsive bradycardia pacing and diagnostics.

The study will be a prospective, non-randomized, multicenter clinical study, conducted in approximately 15 centers.

To allow for sufficient experience with the device, a maximum of 80 subjects may be implanted with the Secura device. Data will be collected at baseline (enrollment), implant, 1-, 3-, and 6- months post implant and every 6 months thereafter or until study closure (whichever occurs first), Unscheduled Follow-up visits, System Modifications, Technical Observations, Study Deviations, Study Exit, upon notification of new or updated Adverse Events and in case of death.

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.

Primary outcomes:
measure: Freedom From Unanticipated Serious Adverse Device Effects at 1-month Post Implant.
timeFrame: 1 month
Secondary outcomes:
measure: System Performance Assessed by Holter Records
timeFrame: 1 month
measure: Adverse Events
timeFrame: 1 Month
measure: System Performance Assessed by Save to Disk Files
timeFrame: 1 month follow-up
measure: System Performance Assessed by Technical Observations
timeFrame: 1 month follow-up
Other outcomes:
Locations:
city: Wels
country: Austria
city: Tampere
country: Finland
city: Goettigen
country: Germany
city: Hannover
country: Germany
city: Homburg/Saar
country: Germany
city: Kaiserslautern
country: Germany
city: Luedenscheid
country: Germany
city: Muenster
country: Germany
city: Athens
country: Greece
city: Breda
country: Netherlands
city: Enschede
country: Netherlands
city: Riyadh
country: Saudi Arabia
city: Lund
country: Sweden
Study officials:
affiliation: Medtronic Cardiac Rhythm and Heart Failure
name: Secura Clinical Study Team
role: STUDY_CHAIR
References:
citation: Murgatroyd FD, Helmling E, Lemke B, Eber B, Mewis C, van der Meer-Hensgens J, Chang Y, Khalameizer V, Katz A. Manual vs. automatic capture management in implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators. Europace. 2010 Jun;12(6):811-6. doi: 10.1093/europace/euq053. Epub 2010 Mar 14.