Ventricular Pace Suppression Study

Overview

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

Full Title of Study: “Ventricular Pace Suppression Study With the EVIA/ENTOVIS DR-T/DR Pacemaker”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Participant)
  • Study Primary Completion Date: September 2011

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Other: Ventricular Pace Suppression- ON
  • Other: Ventricular Pace Suppression- OFF

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Biotronik SE & Co. KG
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Hendrik Bonnemeier, Prof. Dr., Principal Investigator, Klinik für Kardiologie und Angiologie, UNIVERSITÄTSKLINIKUM Schleswig-Holstein, Campus Kiel

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