SecuraTM ICD Clinical Evaluation Study - Study Results

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Tachyarrhythmias
Intervention:	Device: Implantable Cardioverter Defibrillator

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
1	No text entered.

Participant Flow: Overall Study

	1
STARTED	81
COMPLETED	79
NOT COMPLETED	2
Device not implanted	1
Death	1

Baseline Characteristics

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Reporting Groups

	Description
1	No text entered.

Baseline Measures

	1
Number of Participants [units: participants]	81
Age [units: participants]
<=18 years	0
Between 18 and 65 years	42
>=65 years	39
Age [units: years] Mean ± Standard Deviation	63.4 ± 10.45
Gender [units: participants]
Female	18
Male	63
Region of Enrollment [units: participants]
Austria	10
Germany	48
Netherlands	10
Greece	4
Saudi Arabia	3
Finland	3
Sweden	3

Outcome Measures

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1. Primary:

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

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2. Secondary:

Describe System Performance [ Time Frame: 1 month ]

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3. Secondary:

Adverse Events [ Time Frame: 1 Month ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: In most cases, contracts allow investigators to publish study results per the publication plan/protocol following Medtronic's review to determine whether confidential information ("CI") is disclosed. Any such CI is deleted prior to publication/presentation. Medtronic may not censor/interfere with the publication except as described. Investigators may not publish any single-site publications until the main multi-site study publication has occurred.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: CRDM Core Clinical Organization
Organization: Medtronic CRDM
phone: 800-328-2518
e-mail: jamie.l.reynolds@medtronic.com

No publications provided by Medtronic Bakken Research Center

Publications automatically indexed to this study:

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. Epub 2010 Mar 14.

ClinicalTrials.gov Identifier:	NCT00526227 History of Changes
Other Study ID Numbers:	111
Study First Received:	September 6, 2007
Results First Received:	January 13, 2009
Last Updated:	April 21, 2009
Health Authority:	Sweden: Medical Products Agency; Finland: Finnish Medicines Agency; Netherlands: Dutch Health Care Inspectorate; Germany: Federal Institute for Drugs and Medical Devices; Austria: Federal Ministry for Health and Women; Greece: Ministry of Health and Welfare; Israel: Ministry of Health