SD01 Master Study (Safety and Efficacy 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

163 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2024-09-25

Brief Summary

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The study is designed to confirm safety and efficacy of the SD01 ICD (implantable cardioverter-defibrillator) lead.

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Detailed Description

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Conditions

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Ventricular Tachycardia Ventricular Fibrillation Heart Failure

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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SD01 ICD lead

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Standard indication for an ICD/CRT-D therapy
* Signed informed consent form
* Patient is willing and able to participate for the whole study duration
* Patient is willing and able to activate and use the CardioMessenger
* Legal capacity and ability to consent.

Exclusion Criteria

* Standard contraindication for an ICD/CRT-D therapy
* Age \<18 years.
* Pregnant or breastfeeding
* Cardiac surgery is planned within the next six months
* Any condition that in the opinion of the investigator would preclude compliance with the study protocol during the whole follow-up period
* Enrollment in another cardiac clinical investigation with active treatment arm
* Mechanical tricuspid valve prosthesis or severe tricuspid valve disease
* Dexamethasone acetate intolerance

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No