SD01 Registry (SD01 ICD Lead)
SD01 Registry
1 other identifier
observational
280
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2014
Longer than P75 for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 4, 2013
CompletedFirst Posted
Study publicly available on registry
December 18, 2013
CompletedStudy Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 26, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 26, 2024
CompletedJanuary 23, 2025
January 1, 2024
10.6 years
December 4, 2013
January 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
SADE-free rate
10 years
Other Outcomes (7)
Pacing threshold of SD01
3-month follow-up
Sensing amplitude of SD01
3-month follow-up
Device deficiencies
10 years
- +4 more other outcomes
Study Arms (1)
SD01 ICD lead
Interventions
Eligibility Criteria
Patients with standard ICD/CRT-D (cardiac resynchronization therapy plus defibrillator) indication
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
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, 23538, 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, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 10 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2013
First Posted
December 18, 2013
Study Start
March 1, 2014
Primary Completion
September 26, 2024
Study Completion
September 26, 2024
Last Updated
January 23, 2025
Record last verified: 2024-01