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Completed

NCT Number: NCT02014675

SD01 Registry (SD01 ICD Lead)

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.

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Key information

Conditions

Ventricular Fibrillation Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Heart Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular Ventricular Tachycardia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

DRK Klinikum Berlin-Köpenick, Berlin, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SD01 ICD lead

Device

Primary outcomes

  1. SADE-free rate

    Time frame: 10 years

Other outcomes

  1. Pacing threshold of SD01

    Time frame: 3-month follow-up

  2. Sensing amplitude of SD01

    Time frame: 3-month follow-up

  3. Device deficiencies

    Time frame: 10 years

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

    Time frame: 10 years

  5. Analysis of arrhythmias and their treatment

    Time frame: until 3-month follow-up

  6. ICD/CRT-D system performance

    Time frame: 10 years

  7. SD01 implantation information, handling and operation time record

    Time frame: Implantation

Sponsors and collaborators

Lead sponsor

Biotronik SE & Co. KG

Industry

Registry information

Acronym: SD01 Registry

Important dates

Study start
2014
Primary completion
2024
Study completion
2024
First posted
Dec 18, 2013
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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