Setrox JS Master Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

66 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-31

Study Completion Date

2014-10-31

Brief Summary

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

Detailed Description

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Conditions

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Cardiac Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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SV. Anny Clinic Brno

Brno, , Czechia

Site Status

Countries

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Czechia

Other Identifiers

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56

Identifier Type: -

Identifier Source: org_study_id