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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT00916344
First received: June 4, 2009
Last updated: October 4, 2011
Last verified: October 2011
History of Changes
  Purpose

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 Intervention
Pacemaker Indication
 Device: EVIA Pacemaker

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Master Study of the EVIA DR-T/DR/SR-T/SR Pacemaker

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

Primary Outcome Measures:
  • Efficacy of Atrial Capture Control Feature (Automatic Atrial Threshold Test Minus Manual Atrial Measurement) [ Time Frame: 1 month follow-up completed ] [ Designated as safety issue: No ]

    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:
  • Complication Free Rate [ Time Frame: 1- and 3- month follow-up completed ] [ Designated as safety issue: Yes ]

    Complication free rate (in %):

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



Enrollment: 175
Study Start Date: June 2009
Study Completion Date: March 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pacemaker therapy Device: EVIA Pacemaker
patient has standard indication for pacemaker therapy

  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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00916344

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

No publications provided

Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT00916344     History of Changes
Other Study ID Numbers: 38-1
Study First Received: June 4, 2009
Results First Received: July 27, 2011
Last Updated: October 4, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on May 23, 2013