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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Biotronik SE & Co. KG.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT00943046
First received: July 14, 2009
Last updated: February 12, 2010
Last verified: July 2009
  Purpose

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 ] [ Designated as safety issue: Yes ]
  • Ventricular threshold of SIELLO T (passive fixation) [ Time Frame: 3 month follow-up visits ] [ Designated as safety issue: Yes ]
  • Atrial threshold of SIELLO S (active fixation) [ Time Frame: 3 month follow-up visits ] [ Designated as safety issue: Yes ]

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
  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00943046

Contacts
Contact: Anselm Schaumann, Dr. +49-40-1818818365 a.schaumann@asklepios.com

Locations
Germany
Allgemeines Krankenhaus Hamburg Altona Recruiting
Hamburg, Germany, 22763
Contact: Anselm Schaumann, Dr.       a.schaumann@asklepios.com   
Principal Investigator: Anselm Schaumann, Dr.         
Sponsors and Collaborators
Biotronik SE & Co. KG
Investigators
Principal Investigator: Anselm Schaumann, Dr. n.k.
  More Information

No publications provided

Responsible Party: Mrs. Gundula Herrmann, Biotronik GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT00943046     History of Changes
Other Study ID Numbers: 43-1
Study First Received: July 14, 2009
Last Updated: February 12, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Biotronik SE & Co. KG:
leads
pacemaker
efficacy
safety

ClinicalTrials.gov processed this record on April 14, 2014