Setrox JS Master Study

Cardiac Disease Clinical Trial

Official title:

Efficacy and Safety of the Setrox JS Lead (J=J-shaped, S=Screw)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01487941
• Other study ID #: 56
• Status: Completed
• Phase: N/A
• First received: December 5, 2011
• Last updated: November 19, 2014
• Start date: December 2011
• Est. completion date: October 2014

Study information

• Verified date: November 2014
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionItaly: Ethics CommitteeIsrael: Ethics CommissionCzech Republic: Ethics CommitteeSaudi Arabia: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The purpose of this study is the evaluation of safety and efficacy of the pacemaker lead "Setrox JS".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: October 2014
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases

Locations

Country	Name	City	State
Czech Republic	SV. Anny Clinic Brno	Brno

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serious Adverse Device Effect rate		6 months	Yes
Primary	Atrial pacing threshold from Setrox JS at 3 month follow-up < 1.0V		3 months	No