SD01 Registry (SD01 ICD Lead)

• Sponsor: Biotronik SE & Co. KG (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02014675
• Collaborator: (none)
• Enrollment: 280
• Locations: 10
• Duration (Months): 133
• Patients Per Site: 28
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ventricular Fibrillation; Ventricular Tachycardia; Heart Failure	Device: SD01 ICD lead

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 280 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: SD01 Registry (SD01 ICD Lead)
• Study Start Date: Mar 1, 2014
• Anticipated Primary Completion Date: Dec 1, 2024
• Anticipated Study Completion Date: Apr 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
SD01 ICD lead	Device: SD01 ICD lead

Outcome Measures

Primary Outcome Measures

1. SADE-free rate [10 years]

Other Outcome Measures

1. Pacing threshold of SD01 [3-month follow-up]

2. Sensing amplitude of SD01 [3-month follow-up]

3. Device deficiencies [10 years]

4. Long-term pacing impedance, pacing threshold, sensing amplitude and painless shock impedance of SD01 and other leads, if applicable [10 years]

5. Analysis of arrhythmias and their treatment [until 3-month follow-up]

6. ICD/CRT-D system performance [10 years]

7. SD01 implantation information, handling and operation time record [Implantation]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	DRK Klinikum Berlin-Köpenick	Berlin		Germany
2	Vivantes Humboldt Klinikum Berlin	Berlin		Germany
3	Universitäres Herzzentrum Hamburg	Hamburg		Germany
4	Klinikum Leverkusen	Leverkusen		Germany
5	University Clinic of Schleswig-Holstein	Lübeck		Germany	23538
6	Carl-von-Basedow Klinik	Merseburg		Germany
7	Marienkrankenhaus Papenburg	Papenburg		Germany
8	DRK Krankenhaus Moelln-Ratzeburg	Ratzeburg		Germany
9	SRH Zentralklinikum Suhl	Suhl		Germany
10	Universitätsklinik Würzburg	Würzburg		Germany

Sponsors and Collaborators

• Biotronik SE & Co. KG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Biotronik SE & Co. KG
• ClinicalTrials.gov Identifier: NCT02014675
• Other Study ID Numbers: 67 (TA108)
• First Posted: Dec 18, 2013
• Last Update Posted: Jul 8, 2022
• Last Verified: Jun 1, 2022

• Keywords provided by Biotronik SE & Co. KG: ICD; CRT-D; Lead
• Additional relevant MeSH terms: Tachycardia; Tachycardia, Ventricular; Ventricular Fibrillation

Study Results

No Results Posted as of Jul 8, 2022