SecuraTM ICD Clinical Evaluation Study

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)

Study Overview

• Status: Completed
• Conditions: Tachyarrhythmias
• Intervention / Treatment: Device: Secura 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 Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Wels, Austria
• Finland
  • Tampere, Finland
• Germany
  • Goettigen, Germany
  • Hannover, Germany
  • Homburg/Saar, Germany
  • Kaiserslautern, Germany
  • Luedenscheid, Germany
  • Muenster, Germany
• Greece
  • Athens, Greece
• Netherlands
  • Breda, Netherlands
  • Enschede, Netherlands
• Saudi Arabia
  • Riyadh, Saudi Arabia
• Sweden
  • Lund, Sweden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Secura ICD implant; Secura ICD device implanted	Device: Secura ICD; Secura Implantable Cardioverter Defibrillator (ICD) will be implanted; Other Names: Secura TM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 month
Adverse Events	Number of Adverse Events reported in the implanted subjects.	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.	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.	1 month follow-up

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Investigators: Study Chair: Secura Clinical Study Team, Medtronic Cardiac Rhythm and Heart Failure

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: September 6, 2007
• First Submitted That Met QC Criteria: September 6, 2007
• First Posted (Estimated): September 10, 2007

Study Record Updates

• Last Update Posted (Actual): July 2, 2025
• Last Update Submitted That Met QC Criteria: June 30, 2025
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Tachycardia; Anti-Infective Agents; Antifungal Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Enzyme Inhibitors; Steroid Synthesis Inhibitors; Hormone Antagonists; Cytochrome P-450 Enzyme Inhibitors; Anti-Infective Agents, Local; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; 14-alpha Demethylase Inhibitors; Clotrimazole; Miconazole
• Other Study ID Numbers: 111 (Shenzhen Universisty general hospital)