Lumax 740 Master Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

189 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-11-30

Brief Summary

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The objective of this study is to prove the safety and efficacy of the Lumax 740 ICD family. Primarily, the newly implemented RV/LV Capture Control algorithm is evaluated, which automatically measures the RV/LV threshold and subsequently adjusts the pacing output.

Detailed Description

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Conditions

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Safety and Efficacy of the Lumax 740 ICD Family

Keywords

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ICD therapy RV/LV Capture Control Safety and Efficacy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Legal capacity and ability to consent
* Signed patient informed consent

In addition for HF-T devices:

* Bipolar LV-lead with a min. distance of 15 mm between tip and ring
* True bipolar RV lead

Exclusion Criteria

* Standard contraindication for single, dual, or triple chamber ICD.

* Age \< 18 years
* Pregnant or breast-feeding woman
* Cardiac surgery planned within the next 6 months
* Life expectancy of less than 6 months
* Participating in any other clinical study of an investigational cardiac drug or device

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gunnar Klein, Prof. Dr.

Role: STUDY_CHAIR

Herz im Zentrum Hannover, Germany

Locations

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Medical School Hannover

Hanover, , Germany

Site Status

Countries

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Germany

Other Identifiers

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55

Identifier Type: -

Identifier Source: org_study_id