SD01 Registry (SD01 ICD Lead)

Completed

• Conditions: Ventricular Fibrillation; Heart Failure; Ventricular Tachycardia
• Interventions: Device: SD01 ICD lead

• Registration Number: NCT02014675
• Lead Sponsor: Biotronik SE & Co. KG

Brief Summary

This registry is designed to gather further evidence, in addition to the SD01 Master Study, for the safety and efficacy of the SD01 ICD lead.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-04
• Study First Submitted QC: 2013-12-12
• Study First Posted: 2013-12-18
• Study Start: 2014-03
• Status Verified: 2024-01
• Primary Completion: 2024-09-26
• Study Completion: 2024-09-26
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

• Meet a standard indication for ICD/CRT-D therapy
• First ICD/CRT-D implantation or upgrade from pacemaker
• Signed informed consent form
• Willing to participate for the whole duration of the registry
• Patient accepts Home Monitoring concept and is able to activate and use the Cardiomessenger
• Patient has legal capacity and ability to consent

Exclusion Criteria

• Meet a standard contraindication for an ICD/CRT-D therapy
• Age <18 years
• Pregnant or breast-feeding women
• Cardiac surgery planned within the next six months
• Enrollment in another cardiac clinical investigation with active treatment arm
• Mechanical tricuspid valve prosthesis or severe tricuspid valve disease
• Dexamethasone acetate intolerance

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SD01 ICD lead	SD01 ICD lead	-

Primary Outcome Measures

Name	Time	Method
SADE-free rate	10 years

Trial Locations

Locations (10)

Klinikum Leverkusen; 🇩🇪 Leverkusen, Germany

DRK Klinikum Berlin-Köpenick; 🇩🇪 Berlin, Germany

Vivantes Humboldt Klinikum Berlin; 🇩🇪 Berlin, Germany

Universitäres Herzzentrum Hamburg; 🇩🇪 Hamburg, Germany

Carl-von-Basedow Klinik; 🇩🇪 Merseburg, Germany

Marienkrankenhaus Papenburg; 🇩🇪 Papenburg, Germany

DRK Krankenhaus Moelln-Ratzeburg; 🇩🇪 Ratzeburg, Germany

University Clinic of Schleswig-Holstein; 🇩🇪 Lübeck, Germany

SRH Zentralklinikum Suhl; 🇩🇪 Suhl, Germany

Universitätsklinik Würzburg; 🇩🇪 Würzburg, Germany