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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by Biotronik SE & Co. KG.
Recruitment status was:  Recruiting
Information provided by:
Biotronik SE & Co. KG Identifier:
First received: July 14, 2009
Last updated: February 12, 2010
Last verified: July 2009
The objective of this study is to prove the safety and efficacy of the SIELLO pacemaker leads.

Condition Intervention Phase
Pacemaker Indication Device: Pacemaker lead Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Master Study of the SIELLO Pacemaker Leads

Further study details as provided by Biotronik SE & Co. KG:

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

Estimated Enrollment: 160
Study Start Date: July 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Pacemaker lead
    Implantation of the SIELLO pacemaker leads

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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.
  More Information

Responsible Party: Mrs. Gundula Herrmann, Biotronik GmbH & Co. KG Identifier: NCT00943046     History of Changes
Other Study ID Numbers: 43-1
Study First Received: July 14, 2009
Last Updated: February 12, 2010

Keywords provided by Biotronik SE & Co. KG:
safety processed this record on July 19, 2017