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Completed

NCT Number: NCT01836497

SD01 Master Study (Safety and Efficacy Study)

The study is designed to confirm safety and efficacy of the SD01 ICD (implantable cardioverter-defibrillator) lead.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Ann University Hospital, Brno, Czechia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Standard indication for an ICD/CRT-D therapy
  • Signed informed consent form
  • Patient is willing and able to participate for the whole study duration
  • Patient is willing and able to activate and use the CardioMessenger
  • Legal capacity and ability to consent.

Exclusion criteria

  • Standard contraindication for an ICD/CRT-D therapy
  • Age <18 years.
  • Pregnant or breastfeeding
  • Cardiac surgery is planned within the next six months
  • Any condition that in the opinion of the investigator would preclude compliance with the study protocol during the whole follow-up period
  • 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. Rate of appropriate sensing and pacing

    Time frame: at the 3-month follow-up

    The evaluation of right ventricular sensing performance is based on the assessment of consecutive intrinsic beats documented with markers on an IEGM (intra-cardiac electrogram). The evaluation of ventricular sensing performance is based on the data to be collected during the 3-month follow-up. The appropriate pacing performance in the right ventricle results from the evaluation of "capture" at the end of the 3-month follow-up.

  2. Serious adverse device effects (SADEs) related to the SD01 lead

    Time frame: until the 3-month follow-up

Secondary outcomes

  1. Comparison of pacing threshold between Linoxsmart and SD01

    Time frame: at the 3-month follow-up

    Comparison of the manually measured pacing threshold of the SD01 lead system to the Linox SD lead at 3-month follow-up. The idea is that the pacing threshold will be similar within a suitable range.

  2. Shift rate of the painless shock impedance measurement

    Time frame: between 3- and 6-month follow-up

Sponsors and collaborators

Lead sponsor

Biotronik SE & Co. KG

Industry

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2024
First posted
Apr 22, 2013
Registry last updated
Jan 22, 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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