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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. Identifier: NCT00943046
Recruitment Status : Unknown
Verified July 2009 by Biotronik SE & Co. KG.
Recruitment status was:  Recruiting
First Posted : July 21, 2009
Last Update Posted : February 15, 2010
Information provided by:
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
Pacemaker Indication Device: Pacemaker lead Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 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
Estimated Primary Completion Date : November 2009
Estimated Study Completion Date : December 2010

Intervention Details:
    Device: Pacemaker lead
    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, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier (NCT number): NCT00943046

Contact: Anselm Schaumann, Dr. +49-40-1818818365

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

Responsible Party: Mrs. Gundula Herrmann, Biotronik GmbH & Co. KG Identifier: NCT00943046     History of Changes
Other Study ID Numbers: 43-1
First Posted: July 21, 2009    Key Record Dates
Last Update Posted: February 15, 2010
Last Verified: July 2009

Keywords provided by Biotronik SE & Co. KG: