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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00943046
Other study ID # 43-1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2009
Est. completion date December 2010

Study information

Verified date May 2017
Source Biotronik SE & Co. KG
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study is to prove the safety and efficacy of the SIELLO pacemaker leads.


Description:

The assessment of the safety of SIELLO pacemaker leads is based on the collection of complications which are related to the leads. The assessment of efficacy of the SIELLO pacemaker leads is based on the collection of standard electrical lead data during the implant and follow-up procedures. Subsequent to the implantation of the SIELLO leads,five follow-up visits have been scheduled: at pre-discharge and after 1, 3, 6 and 12 months.


Recruitment information / eligibility

Status Completed
Enrollment 164
Est. completion date December 2010
Est. primary completion date November 2009
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Meet the indications for pacemaker therapy

- Understand the nature of the procedure

- Give informed consent

- Able to complete all testing required by the clinical protocol

- Available for follow-up visits on a regular basis at the investigational site

Exclusion Criteria:

- Meet none of the pacemaker indications

- Meet one or more of the contraindications

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Pacemaker therapy
Implantation of the SIELLO pacemaker leads

Locations

Country Name City State
Germany Allgemeines Krankenhaus Hamburg Altona Hamburg

Sponsors (1)

Lead Sponsor Collaborator
Biotronik SE & Co. KG

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Complication free rate of all SIELLO leads 3 month follow-up visits
Primary Ventricular threshold of SIELLO T (passive fixation) 3 month follow-up visits
Primary Atrial threshold of SIELLO S (active fixation) 3 month follow-up visits
See also
  Status Clinical Trial Phase
Withdrawn NCT03917251 - The Effects of Trans Venous Cardiac Pacing on Coronary Microvascular Function and Hemodynamics N/A