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Evaluation of Pacemaker Algorithms to Avoid Unnecessary Right Ventricular Pacing (ADVANTAGE)

Primary Purpose

Pacemaker Implantation for Sinus Node Disease

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
pacemaker programming to mode switch to atrial pacing versus atrioventricular hysteresis function
Sponsored by
Deutsches Herzzentrum Muenchen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pacemaker Implantation for Sinus Node Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Indication for the implantation of a dual-chamber pacemaker

Exclusion Criteria:

Persistent or permanent atrial tachyarrhythmias atrioventricular block 2nd or 3rd degree indication or the implantation of an defibrillator

Sites / Locations

  • Klinikum Bamberg
  • Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen
  • Krankenhaus Peißenberg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

mode switch to atrial pacing

atrioventricular hysteresis function

Arm Description

Outcomes

Primary Outcome Measures

Right ventricular pacing percentage

Secondary Outcome Measures

BNP levels

Full Information

First Posted
February 28, 2013
Last Updated
April 7, 2017
Sponsor
Deutsches Herzzentrum Muenchen
Collaborators
Klinikum Bamberg, Krankenhaus Peißenberg, Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT01803217
Brief Title
Evaluation of Pacemaker Algorithms to Avoid Unnecessary Right Ventricular Pacing
Acronym
ADVANTAGE
Official Title
AV-Hysteresis Versus Mode Switch to AAI (MVP) for the Avoidance of Unnecessary Right Ventricular Pacing
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
November 2007 (Actual)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Deutsches Herzzentrum Muenchen
Collaborators
Klinikum Bamberg, Krankenhaus Peißenberg, Medtronic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Unnecessary right ventricular pacing has been shown to be detrimental in recipients of implantable pacemaker or defibrillators. The ADVANTAGE study evaluates the efficacy of two pacemaker based algorithms (atrioventricular hysteresis function versus mode switch to atrial pacing) to reduce right ventricular pacing.
Detailed Description
Comparison of the effect of an atrioventricular hysteresis function with a mode switch to atrial pacing on the right ventricular pacing percentage in a multi-centre, prospective, randomized, single blinded, cross-over study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pacemaker Implantation for Sinus Node Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mode switch to atrial pacing
Arm Type
Experimental
Arm Title
atrioventricular hysteresis function
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
pacemaker programming to mode switch to atrial pacing versus atrioventricular hysteresis function
Primary Outcome Measure Information:
Title
Right ventricular pacing percentage
Time Frame
3 months
Secondary Outcome Measure Information:
Title
BNP levels
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Occurrence of atrial tachyarrhythmias
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Indication for the implantation of a dual-chamber pacemaker Exclusion Criteria: Persistent or permanent atrial tachyarrhythmias atrioventricular block 2nd or 3rd degree indication or the implantation of an defibrillator
Facility Information:
Facility Name
Klinikum Bamberg
City
Bamberg
State/Province
Bayern
ZIP/Postal Code
96049
Country
Germany
Facility Name
Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen
City
München
State/Province
Bayern
ZIP/Postal Code
80636
Country
Germany
Facility Name
Krankenhaus Peißenberg
City
Peißenberg
State/Province
Bayern
ZIP/Postal Code
82380
Country
Germany

12. IPD Sharing Statement

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Evaluation of Pacemaker Algorithms to Avoid Unnecessary Right Ventricular Pacing

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