Linox Smart S DX PME/Master Study

Biotronik

Status and phase: Completed; Phase 4

Conditions: ICD Indication

Treatments: Device: Linox smart S DX

Study type: Interventional

Funder types: Industry

Identifiers

NCT01090401

48-1

Details and patient eligibility

About

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

Enrollment: 116 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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116 participants in 1 patient group

Patients with Linox smart S DX lead

Experimental group

Treatment:

Device: Linox smart S DX