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Setrox JS Master Study

This study has been completed.
Information provided by (Responsible Party):
Biotronik SE & Co. KG Identifier:
First received: December 5, 2011
Last updated: November 19, 2014
Last verified: November 2014
The purpose of this study is the evaluation of safety and efficacy of the pacemaker lead "Setrox JS".

Cardiac Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Efficacy and Safety of the Setrox JS Lead (J=J-shaped, S=Screw)

Further study details as provided by Biotronik SE & Co. KG:

Primary Outcome Measures:
  • Serious Adverse Device Effect rate [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Atrial pacing threshold from Setrox JS at 3 month follow-up < 1.0V [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 66
Study Start Date: December 2011
Study Completion Date: October 2014
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with pacemaker indication

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01487941

Czech Republic
SV. Anny Clinic Brno
Brno, Czech Republic, 656 91
Sponsors and Collaborators
Biotronik SE & Co. KG
  More Information

Responsible Party: Biotronik SE & Co. KG Identifier: NCT01487941     History of Changes
Other Study ID Numbers: 56 
Study First Received: December 5, 2011
Last Updated: November 19, 2014
Health Authority: Germany: Ethics Commission
Italy: Ethics Committee
Israel: Ethics Commission
Czech Republic: Ethics Committee
Saudi Arabia: Ethics Committee

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases processed this record on September 30, 2016