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Completed

NCT Number: NCT00943046

Master Study for the Investigation of Safety and Efficacy of the SIELLO Pacemaker Leads

The objective of this study is to prove the safety and efficacy of the SIELLO pacemaker leads.

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Key information

Conditions

Cardiac Pacemaker Syndrome

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Allgemeines Krankenhaus Hamburg Altona

Hamburg, 22763, Germany

About this study

The assessment of the safety of SIELLO pacemaker leads is based on the collection of complications which are related to the leads. The assessment of efficacy of the SIELLO pacemaker leads is based on the collection of standard electrical lead data during the implant and follow-up procedures. Subsequent to the implantation of the SIELLO leads,five follow-up visits have been scheduled: at pre-discharge and after 1, 3, 6 and 12 months.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Meet the indications for pacemaker therapy
  • Understand the nature of the procedure
  • Give informed consent
  • Able to complete all testing required by the clinical protocol
  • Available for follow-up visits on a regular basis at the investigational site

Exclusion criteria

  • Meet none of the pacemaker indications
  • Meet one or more of the contraindications
  • Have a life expectancy of less than six months
  • Cardiac surgery in the next six months -Enrolled in another cardiac clinical investigation- Have other medical devices that may interact with the implanted pacemaker

Treatment and study plan

Pacemaker therapy

Device

Implantation of the SIELLO pacemaker leads

Primary outcomes

  1. Complication free rate of all SIELLO leads

    Time frame: 3 month follow-up visits

  2. Ventricular threshold of SIELLO T (passive fixation)

    Time frame: 3 month follow-up visits

  3. Atrial threshold of SIELLO S (active fixation)

    Time frame: 3 month follow-up visits

Sponsors and collaborators

Lead sponsor

Biotronik SE & Co. KG

Industry

Registry information

Official study title

Master Study of the SIELLO Pacemaker Leads

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Jul 21, 2009
Registry last updated
Jul 26, 2019

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.