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

October 4, 2011 updated by: Biotronik SE & Co. KG

Master Study of the EVIA DR-T/DR/SR-T/SR Pacemaker

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

175

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Bordeaux
      • Pessac, Bordeaux, France, F - 33604
        • CHU Bordeaux Haut-Leveque

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Pacemaker therapy
Device: EVIA Pacemaker
patient has standard indication for pacemaker therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month follow-up completed

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
1- and 3- month follow-up completed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotronik SE & Co. KG

Investigators

  • Principal Investigator: Philippe Ritter, Dr., CHU Bordeaux Haut-Leveque

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (ACTUAL)

February 1, 2010

Study Completion (ACTUAL)

March 1, 2010

Study Registration Dates

First Submitted

June 4, 2009

First Submitted That Met QC Criteria

June 8, 2009

First Posted (ESTIMATE)

June 9, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

October 7, 2011

Last Update Submitted That Met QC Criteria

October 4, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • 38-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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