Ventricular Pace Suppression Study (VpS)

October 24, 2011 updated by: Biotronik SE & Co. KG

Ventricular Pace Suppression Study With the EVIA/ENTOVIS DR-T/DR Pacemaker

Investigation of the efficacy and safety of the Ventricular Pace Suppression (VpS) algorithm.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to investigate the percentage of reduction of ventricular pacing using the VpS feature of the EVIA/ENTOVIS pacemaker in a controlled clinical investigation.

Study Type

Interventional

Enrollment (Anticipated)

84

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

  • Germany
    • Bavaria
      • Coburg, Bavaria, Germany, 96450
        • Klinikum Coburg gGmbH
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Abteilung für Elektrophysiologie, Klinik für Kardiologie und Angiologie, UNIVERSITÄTSKLINIKUM Schleswig-Holstein

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:

  • Paroxysmal AV block and/or Sinus Node Dysfunction
  • DDD(R)-ADI(R)-Mode (VpS Algorithm) applicability

Exclusion Criteria:

  • Permanent AV block III°
  • Permanent Atrial Fibrillation/ Flutter
  • Require mode other than DDD(R)-ADI(R) or DDD(R)
  • Have a life expectancy of less than six months
  • Expected to receive heart surgery within six months
  • Enrolled in another cardiac investigation

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: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Ventricular Pace Suppression- ON
Device: VpS algorithm in EVIA and ENTOVIS pacemakers
For one group of patients, the VpS algorithm will be activated and for the other group, the VpS algorithm will be deactivated until the cross-over, where these conditions will be switched.
OTHER: Ventricular Pace Suppression- OFF
Device: VpS algorithm in EVIA and ENTOVIS pacemakers
For one group of patients, the VpS algorithm will be activated and for the other group, the VpS algorithm will be deactivated until the cross-over, where these conditions will be switched.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction of right ventricular pacing with the help of the VpS algorithm in the EVIA/ ENTOVIS pacemakers.
Time Frame: 6-8 months
6-8 months

Secondary Outcome Measures

Outcome Measure
Time Frame
A Complication free rate >95%, with respect to the VpS feature of the implanted pacemaker.
Time Frame: 6-8 months
6-8 months

Collaborators and Investigators

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

Sponsor

Biotronik SE & Co. KG

Investigators

  • Principal Investigator: Hendrik Bonnemeier, Prof. Dr., Klinik für Kardiologie und Angiologie, UNIVERSITÄTSKLINIKUM Schleswig-Holstein, Campus Kiel

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

January 1, 2010

Primary Completion (ACTUAL)

September 1, 2011

Study Completion (ACTUAL)

September 1, 2011

Study Registration Dates

First Submitted

January 19, 2010

First Submitted That Met QC Criteria

January 20, 2010

First Posted (ESTIMATE)

January 21, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

October 25, 2011

Last Update Submitted That Met QC Criteria

October 24, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 45

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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