Lumax 740 Master Study

PME/Master Study of the Lumax 740 ICD Family

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01454050

Acronym

Lumax 740

Enrollment

189

Registered

2011-10-18

Start date

2011-11-30

Completion date

2012-11-30

Last updated

2012-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Safety and Efficacy of the Lumax 740 ICD Family

Keywords

ICD therapy, RV/LV Capture Control, Safety and Efficacy

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Inclusion Criteria: Standard indication for single, dual, or triple chamber ICD. * 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

Design outcomes

Primary

Measure	Time frame
Efficacy of the automatic Capture Control feature	PHD, 1-, 3- and 6-month follow-up

Countries

Germany

Outcome results