SD01 Registry (SD01 ICD Lead)

Heart Failure Clinical Trial

— SD01 Registry  

Official title:

SD01 Registry (SD01 ICD Lead)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02014675
• Other study ID #: 67 (TA108)
• Status: Active, not recruiting
• Start date: March 2014
• Est. completion date: April 2025

Study information

• Verified date: January 2024
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 280
• Est. completion date: April 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Fibrillation
• Ventricular Tachycardia

Intervention

Device:
• SD01 ICD lead

Locations

Country	Name	City	State
Germany	DRK Klinikum Berlin-Köpenick	Berlin
Germany	Vivantes Humboldt Klinikum Berlin	Berlin
Germany	Universitäres Herzzentrum Hamburg	Hamburg
Germany	Klinikum Leverkusen	Leverkusen
Germany	University Clinic of Schleswig-Holstein	Lübeck
Germany	Carl-von-Basedow Klinik	Merseburg
Germany	Marienkrankenhaus Papenburg	Papenburg
Germany	DRK Krankenhaus Moelln-Ratzeburg	Ratzeburg
Germany	SRH Zentralklinikum Suhl	Suhl
Germany	Universitätsklinik Würzburg	Würzburg

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pacing threshold of SD01		3-month follow-up
Other	Sensing amplitude of SD01		3-month follow-up
Other	Device deficiencies		10 years
Other	Long-term pacing impedance, pacing threshold, sensing amplitude and painless shock impedance of SD01 and other leads, if applicable		10 years
Other	Analysis of arrhythmias and their treatment		until 3-month follow-up
Other	ICD/CRT-D system performance		10 years
Other	SD01 implantation information, handling and operation time record		Implantation
Primary	SADE-free rate		10 years