Linox Smart S DX PME/Master Study

PME/Master Study of the Linoxsmart S DX ICD Leads

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01090401

Enrollment

116

Registered

2010-03-22

Start date

2010-03-31

Completion date

2011-10-31

Last updated

2011-11-16

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

Conditions

ICD Indication

Brief summary

The objective of this study is to prove the safety and efficacy of the Linox smart S DX ICD lead.

Interventions

DEVICELinox smart S DX

ICD lead

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with standard ICD indication * Be available for follow-up visits on a regular basis at an approved investigational center

Exclusion criteria

* Patients with standard ICD contra-indication * Patients with permanent atrial fibrillation * Have a life expectancy of less than six months * Are expecting to receive cardiac surgery within 6 months after enrollment * Age \< 18 years * Not enrolled in another cardiac clinical investigation

Design outcomes

Primary

Measure	Time frame
Rate of atrial adequate sensing	6 months

Secondary

Measure	Time frame
Linox smart S DX related complication-free rate	6 months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026