Setrox JS Master Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT01487941
First received: December 5, 2011
Last updated: September 11, 2013
Last verified: September 2013
  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)

Resource links provided by NLM:


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 ]

Estimated Enrollment: 116
Study Start Date: December 2011
Estimated Study Completion Date: August 2014
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

No publications provided

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: September 11, 2013
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

ClinicalTrials.gov processed this record on September 16, 2014