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Master Study for the Investigation of Safety and Efficacy of the EVIA Pacemaker

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: NCT00916344
Recruitment Status : Completed
First Posted : June 9, 2009
Results First Posted : September 30, 2011
Last Update Posted : October 7, 2011
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 EVIA pacemaker. Primarily, the newly implemented Atrial Capture Control algorithm is evaluated, which automatically measures the right atrial threshold and subsequently adjusts the pacing output.

Condition or disease Intervention/treatment
Pacemaker Indication Device: EVIA Pacemaker

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 175 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Master Study of the EVIA DR-T/DR/SR-T/SR Pacemaker
Study Start Date : June 2009
Primary Completion Date : February 2010
Study Completion Date : March 2010

Arm Intervention/treatment
Experimental: Pacemaker therapy Device: EVIA Pacemaker
patient has standard indication for pacemaker therapy

Primary Outcome Measures :
  1. Efficacy of Atrial Capture Control Feature (Automatic Atrial Threshold Test Minus Manual Atrial Measurement) [ Time Frame: 1 month follow-up completed ]

    atrial capture control: feature that automatically measures the atrial pacing threshold and subsequently adjusts the atrial pulse amplitude.

    atrial threshold test: measurable automatically or manually.

Secondary Outcome Measures :
  1. Complication Free Rate [ Time Frame: 1- and 3- month follow-up completed ]

    Complication free rate (in %):

    1 minus(the number of possibly pacemaker related complications divided by the number of patients)

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
  • Patients with chronic atrial fibrillation (dual chamber pacemaker only)
  • 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): NCT00916344

CHU Bordeaux Haut-Lévêque
Pessac, Bordeaux, France, F - 33604
Sponsors and Collaborators
Biotronik SE & Co. KG
Principal Investigator: Philippe Ritter, Dr. CHU Bordeaux Haut-Lévêque

Responsible Party: Biotronik SE & Co. KG Identifier: NCT00916344     History of Changes
Other Study ID Numbers: 38-1
First Posted: June 9, 2009    Key Record Dates
Results First Posted: September 30, 2011
Last Update Posted: October 7, 2011
Last Verified: October 2011