Trials Sponsors Conditions Drugs Pricing

Conditions

Patients Indicated for an ICD

Keywords

Long-term safety and reliability of ICD leads

Outcome Measures

Primary Outcomes (2)

Percentage of Subjects Who Are Free of Complications Related to the Linox ICD Lead
The overall incidence of complications (serious adverse events that require additional invasive intervention to resolve or specific non-invasive actions) related to the Linox ICD leads implanted with a market-released BIOTRONIK ICD device was evaluated. This was evaluated as a serious adverse event free-rate (SAEFR).
5 years
Number of Subjects Who Experienced Primary Outcome 1 Complication(s) Per Individual Complication Type
Evaluation of the individual types of serious adverse events (SAEs) contributing to primary outcome 1 and their associated SAE category.
5 years

Secondary Outcomes (8)

Number of Subjects Who Experienced Serious Adverse Event(s) Excluded From Primary Outcome 1 (ICD, Device, and Implant Procedure Related) Through 5 Years Post-Implant.
5 years
Number of Subjects Who Experienced Serious Adverse Event(s) Excluded From Primary Outcome 1 (RA Lead Related) Through 5 Years Post-Implant.
5 years
Pacing Threshold Measurements for the Linox Lead System at Scheduled GALAXY Registry Follow-ups Through 5 Years Post-implant.
5 years
Sensing Measurements for the Linox Lead System at Scheduled GALAXY Registry Follow-ups Through 5 Years Post-implant.
5 years
Pacing Impedance Measurements for the Linox Lead System at Scheduled GALAXY Registry Follow-ups Through 5 Years Post-implant.
5 years
+3 more secondary outcomes

Study Arms (1)

Data Collection Group

Device: ICD Therapy - ICD Lead Registry

Interventions

ICD Therapy - ICD Lead RegistryDevice

Collecting long-term safety and efficacy data on a family of market-released ICD leads.

Data Collection Group

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patients will be obtained from the investigators' general patient population according to the inclusion and exclusion criteria described below.

You may qualify if:

Successfully implanted Linox Lead System connected to a BIOTRONIK ICD, from 1-45 days prior to enrollment

Sponsors & Collaborators

Biotronik, Inc.
Industrylead

Study Sites (85)

Albertville, Alabama, United States

Birmingham, Alabama, United States

Gadsden, Alabama, United States

Jasper, Alabama, United States

Glendale, Arizona, United States

Mesa, Arizona, United States

Phoenix, Arizona, United States

Related Publications (1)

Good ED, Cakulev I, Orlov MV, Hirsh D, Simeles J, Mohr K, Moll P, Bloom H. Long-Term Evaluation of Biotronik Linox and Linox(smart) Implantable Cardioverter Defibrillator Leads. J Cardiovasc Electrophysiol. 2016 Jun;27(6):735-42. doi: 10.1111/jce.12971. Epub 2016 May 3.
PMID: 26990515DERIVED

Results Point of Contact

Title: Kelly Mohr
Organization: BIOTRONIK, INC

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Enrollment

1,997 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 2, 2009

First Posted

February 4, 2009

Study Start

December 2008

Date type not reported

This date has not been verified as actual or estimated.

Long-term Evaluation of the Linox Family ICD Leads Registry (GALAXY)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (8)

Study Arms (1)

Data Collection Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (85)

Related Publications (1)

Results Point of Contact

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (8)

Study Arms (1)

Data Collection Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (85)

Related Publications (1)

Results Point of Contact

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations