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Completed

NCT Number: NCT01487941

Setrox JS Master Study

The purpose of this study is the evaluation of safety and efficacy of the pacemaker lead "Setrox JS".

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Key information

Conditions

Cardiac Disease Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

SV. Anny Clinic Brno

Brno, 656 91, Czechia

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
  • Available for follow-up visits on a regular basis at the investigational site
  • Contractual capability and ability to consent
  • Age ≥18 years

Exclusion criteria

  • Meet one or more of the contraindications for pacemaker therapy
  • Permanent atrial fibrillation
  • 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
  • Pregnant and breast-feeding women

Treatment and study plan

Primary outcomes

  1. Serious Adverse Device Effect rate

    Time frame: 6 months

  2. Atrial pacing threshold from Setrox JS at 3 month follow-up < 1.0V

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Biotronik SE & Co. KG

Industry

Registry information

Official study title

Efficacy and Safety of the Setrox JS Lead (J=J-shaped, S=Screw)

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Dec 8, 2011
Registry last updated
Nov 20, 2014

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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