SecuraTM ICD Clinical Evaluation Study

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00526227
• Date of registration: 06/09/2007
• Prospective Registration: Yes
• Primary sponsor: Medtronic Bakken Research Center
• Public title: SecuraTM ICD Clinical Evaluation Study
• Scientific title: Clinical Study to Evaluate System Safety and Clinical Performance of the SecuraTM ICD
• Date of first enrolment: October 2007
• Target sample size: 81
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00526227
• Study type: Interventional
• Phase: N/A

Countries of recruitment

Austria, Finland, Germany, Greece, Netherlands, Saudi Arabia, Sweden

Contacts

• Name: Secura Clinical Study Team
• Affiliation: Medtronic Bakken Research Center

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Tachyarrhythmias

Intervention(s)

Device: Implantable Cardioverter Defibrillator

Primary Outcome(s)

Percentage of Subjects With an Unanticipated Serious Adverse Device Effects at 1-Month Post Implant. [Time Frame: 1 month]

Secondary Outcome(s)

Describe System Performance [Time Frame: 1 month]

Adverse Events [Time Frame: 1 Month]

Secondary ID(s)

111

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 10/06/2009
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00526227