NCT01803217

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 4, 2013

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

April 10, 2017

Status Verified

April 1, 2017

Enrollment Period

4.1 years

First QC Date

February 28, 2013

Last Update Submit

April 7, 2017

Conditions

Pacemaker Implantation for Sinus Node Disease

Outcome Measures

Primary Outcomes (1)

  • Right ventricular pacing percentage

    3 months

Secondary Outcomes (1)

  • BNP levels

    3 months

Other Outcomes (1)

  • Occurrence of atrial tachyarrhythmias

    3 months

Study Arms (2)

mode switch to atrial pacing

EXPERIMENTAL
Other: pacemaker programming to mode switch to atrial pacing versus atrioventricular hysteresis function

atrioventricular hysteresis function

ACTIVE COMPARATOR
Other: pacemaker programming to mode switch to atrial pacing versus atrioventricular hysteresis function

Interventions

pacemaker programming to mode switch to atrial pacing versus atrioventricular hysteresis functionOTHER
atrioventricular hysteresis functionmode switch to atrial pacing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Indication for the implantation of a dual-chamber pacemaker

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Klinikum Bamberg

Bamberg, Bavaria, 96049, Germany

Location

Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen

München, Bavaria, 80636, Germany

Location

Krankenhaus Peißenberg

Peißenberg, Bavaria, 82380, Germany

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2013

First Posted

March 4, 2013

Study Start

November 1, 2007

Primary Completion

December 1, 2011

Study Completion

June 1, 2016

Last Updated

April 10, 2017

Record last verified: 2017-04

Locations

DE(3)