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
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 April 17, 2014