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Master Study for the Investigation of Safety and Efficacy of the SIELLO Pacemaker Leads

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00943046
Recruitment Status : Completed
First Posted : July 21, 2009
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG

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

Condition or disease Intervention/treatment Phase
Cardiac Pacemaker Syndrome Device: Pacemaker therapy Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 164 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Master Study of the SIELLO Pacemaker Leads
Study Start Date : July 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : December 2010

Arm Intervention/treatment
Experimental: Siello pacemaker lead
Patients with Siello Pacemaker lead
Device: Pacemaker therapy
Implantation of the SIELLO pacemaker leads




Primary Outcome Measures :
  1. Complication free rate of all SIELLO leads [ Time Frame: 3 month follow-up visits ]
  2. Ventricular threshold of SIELLO T (passive fixation) [ Time Frame: 3 month follow-up visits ]
  3. Atrial threshold of SIELLO S (active fixation) [ Time Frame: 3 month follow-up visits ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00943046


Locations
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Germany
Allgemeines Krankenhaus Hamburg Altona
Hamburg, Germany, 22763
Sponsors and Collaborators
Biotronik SE & Co. KG
Investigators
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Principal Investigator: Anselm Schaumann, Dr. n.k.

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Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT00943046    
Other Study ID Numbers: 43-1
First Posted: July 21, 2009    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: May 2017
Keywords provided by Biotronik SE & Co. KG:
leads
pacemaker
efficacy
safety