TachyarrhythmiasNCT00526227
SecuraTM ICD Clinical Evaluation Study
A study testing Secura ICD in people with Tachyarrhythmias, run by Medtronic Cardiac Rhythm and Heart Failure at 13 sites in 7 countries.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tachyarrhythmias
- What is being tested?
- Secura ICD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 13 sitesin 7 countries
- Study dates
- Oct 2007to Oct 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
13 sites in 7 countries.
13 sites in 7 countries
Germany6 sites
Study site
Goettigen
Study site
Hanover
Study site
Homburg/Saar
Study site
Kaiserslautern
Study site
Lüdenscheid
Study site
Münster
About this study
Official title: Clinical Study to Evaluate System Safety and Clinical Performance of the SecuraTM ICD
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)
Read the 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.
- Conditions
- Tachyarrhythmias
- Being tested
- Secura ICD
- Medical subject headings
- Tachycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Secura ICDDevice
Also called Secura TM
Secura Implantable Cardioverter Defibrillator (ICD) will be implanted
| Study group | Role | What they receive |
|---|---|---|
| Secura ICD implant | Experimental | Secura ICD device implanted Receives: Device: Secura ICD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom From Unanticipated Serious Adverse Device Effects at 1-month Post Implant.
Criteria to assess the results of the primary objective safety analysis is to demonstrate that the percentage of subjects experiencing an Unanticipated Serious Adverse Device Effect (USADE) is lower than 10% at one-month post-implant, with one month considered to be the same as 28 days.
A pre-specified interim analysis is included in the study which, if the primary objective was met, is to also be considered the final analysis.
Measured: 1 month
Secondary outcomes (4)
System Performance Assessed by Holter Records
The first 21 digital Holter records that were successfully collected in the total of 80 implanted participants will summarize any anomalous or unintended operation and describe device features, ventricular arrhythmia detection times and device classification of ventricular arrhythmias.
Measured: 1 month
Adverse Events
Number of Adverse Events reported in the implanted subjects.
Measured: 1 Month
System Performance Assessed by Save to Disk Files
The Save to Disk files from 79 implanted participants collected after implant and 1 month follow up were reviewed to identify any anomolous or unintended device operation, examine device features, observe ventricular arrhythmia detection times and device classification of ventricular arrhythmias.
Measured: 1 month follow-up
System Performance Assessed by Technical Observations
Reported technical observations will be reviewed to determine if there are any device performance issues.
Measured: 1 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2007 (estimated)
- Study startOct 2007
- Primary completionDec 2007
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TachyarrhythmiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Secura Clinical Study Team, Study chair, Medtronic Cardiac Rhythm and Heart Failure
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00526227
- Sponsor's protocol ID
- 111
- Status last verified
- Nov 2020
- First submitted
- 6 Sep 2007
- Last updated
- 2 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 20231152
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate System Safety and Clinical Performance of the SecuraTM ICD
- ClinicalTrials.gov ID
- NCT00526227
- Acronym / sponsor ID
- 111
- Conditions
- Tachyarrhythmias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 10 Sep 2007 (estimated)
- Results
- Posted 10 Jun 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Secura ICD implant | Experimental | Device: Secura ICDSecura ICD device implanted |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Secura ICDAlso: Secura TMSecura Implantable Cardioverter Defibrillator (ICD) will be implanted | Device | Secura ICD implant |
Primary outcome
Freedom From Unanticipated Serious Adverse Device Effects at 1-month Post Implant.
Time frame: 1 month
Criteria to assess the results of the primary objective safety analysis is to demonstrate that the percentage of subjects experiencing an Unanticipated Serious Adverse Device Effect (USADE) is lower than 10% at one-month post-implant, with one month considered to be the same as 28 days. A pre-specified interim analysis is included in the study which, if the primary objective was met, is to also be considered the final analysis.
4 secondary outcomes
System Performance Assessed by Holter Records
Time frame: 1 month
Adverse Events
Time frame: 1 Month
System Performance Assessed by Save to Disk Files
Time frame: 1 month follow-up
System Performance Assessed by Technical Observations
Time frame: 1 month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20231152Murgatroyd 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Secura Clinical Study Team study chair
Medtronic Cardiac Rhythm and Heart Failure
13 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Secura ICD in people with Tachyarrhythmias, run by Medtronic Cardiac Rhythm and Heart Failure at 13 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Germany, Netherlands, Austria, Finland, Greece and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jun 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom From Unanticipated Serious Adverse Device Effects at 1-month Post Implant. (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00526227, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.