Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Setrox JS Master Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT01487941
First received: December 5, 2011
Last updated: November 19, 2014
Last verified: November 2014
  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

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
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 ClinicalTrials.gov identifier: 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
Study First Received: December 5, 2011
Last Updated: November 19, 2014

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2017