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Setrox JS Master Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01487941
First Posted: December 8, 2011
Last Update Posted: November 20, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Biotronik SE & Co. KG
  Purpose
The purpose of this study is the evaluation of safety and efficacy of the pacemaker lead "Setrox JS".

Condition
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 ]
  • Atrial pacing threshold from Setrox JS at 3 month follow-up < 1.0V [ Time Frame: 3 months ]

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)
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01487941


Locations
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
ClinicalTrials.gov Identifier: NCT01487941     History of Changes
Other Study ID Numbers: 56
First Submitted: December 5, 2011
First Posted: December 8, 2011
Last Update Posted: November 20, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases