NCT00526227

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)

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2007

Geographic Reach
7 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 10, 2007

Completed
21 days until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
8 months until next milestone

Results Posted

Study results publicly available

June 10, 2009

Completed
Last Updated

July 2, 2025

Status Verified

November 1, 2020

Enrollment Period

2 months

First QC Date

September 6, 2007

Results QC Date

January 13, 2009

Last Update Submit

June 30, 2025

Conditions

Tachyarrhythmias

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 month

Secondary Outcomes (4)

  • System Performance Assessed by Holter Records

    1 month

  • Adverse Events

    1 Month

  • System Performance Assessed by Save to Disk Files

    1 month follow-up

  • System Performance Assessed by Technical Observations

    1 month follow-up

Study Arms (1)

Secura ICD implant

EXPERIMENTAL

Secura ICD device implanted

Device: Secura ICD

Interventions

Secura ICDDEVICE

Secura Implantable Cardioverter Defibrillator (ICD) will be implanted

Also known as: Secura TM
Secura ICD implant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Unknown Facility

Wels, Austria

Location

Unknown Facility

Tampere, Finland

Location

Unknown Facility

Goettigen, Germany

Location

Unknown Facility

Hanover, Germany

Location

Unknown Facility

Homburg/Saar, Germany

Location

Unknown Facility

Kaiserslautern, Germany

Location

Unknown Facility

Lüdenscheid, Germany

Location

Unknown Facility

Münster, Germany

Location

Unknown Facility

Athens, Greece

Location

Unknown Facility

Breda, Netherlands

Location

Unknown Facility

Enschede, Netherlands

Location

Unknown Facility

Riyadh, Saudi Arabia

Location

Unknown Facility

Lund, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 20231152DERIVED

MeSH Terms

Conditions

Tachycardia

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
CRDM Core Clinical Organization
Organization
Medtronic CRDM
jamie.l.reynolds@medtronic.com
800-328-2518

Study Officials

  • Secura Clinical Study Team

    Medtronic Cardiac Rhythm and Heart Failure

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2007

First Posted

September 10, 2007

Study Start

October 1, 2007

Primary Completion

December 1, 2007

Study Completion

October 1, 2008

Last Updated

July 2, 2025

Results First Posted

June 10, 2009

Record last verified: 2020-11

Locations

GR(1)AU(1)SA(1)SE(1)NL(2)DE(6)FI(1)