Lumax DX / Linox DX Evaluation

Cardiac Disease Clinical Trial

Official title:

Evaluation of the Lumax DX ICD and the Linox DX Lead (ICD=Implantable Cardioverter Defibrillator, DX=Extended Diagnostics)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01486836
• Other study ID #: 58
• Status: Completed
• Phase: N/A
• First received: November 15, 2011
• Last updated: September 11, 2013
• Start date: November 2011
• Est. completion date: September 2012

Study information

• Verified date: September 2013
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionHungary: Ethics Commission
• Study type: Observational

Clinical Trial Summary

The objective of this study is to investigate the safety and efficacy of the Lumax DX / Linox DX system.

No hypothesis has been defined.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient meets the indication for ICD therapy

• LVEF = 30%

• Patient's compliance with protocol

• Signed patient informed consent form

Exclusion Criteria:

• Patient meets one contraindication for ICD therapy

• Permanent atrial tachyarrhythmia

• Age < 18 years

• Cardiac surgery planned within the next 6 months

• Life expectancy of less than 6 months

• Limited contractual capability

• Participating in another clinical study of an investigational cardiac drug or device

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases

Locations

Country	Name	City	State
Germany	Charité Uniklinikum Benjamin Franklin	Berlin	N.a.

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of appropriate atrial sensing		3 months	No
Primary	Rate of successfully terminated tachyarrhythmia episodes		3 months	No
Primary	Serious adverse device effect rate		3 months	Yes