Evaluation of Pacemaker Algorithms to Avoid Unnecessary Right Ventricular Pacing

Pacemaker Implantation for Sinus Node Disease Clinical Trial

— ADVANTAGE  

Official title:

AV-Hysteresis Versus Mode Switch to AAI (MVP) for the Avoidance of Unnecessary Right Ventricular Pacing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01803217
• Other study ID #: GER-EP-010
• Status: Completed
• Phase: N/A
• First received: February 28, 2013
• Last updated: April 7, 2017
• Start date: November 2007
• Est. completion date: June 2016

Study information

• Verified date: April 2017
• Source: Deutsches Herzzentrum Muenchen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 2016
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pacemaker Implantation for Sinus Node Disease
• Sick Sinus Syndrome

Intervention

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

Locations

Country	Name	City	State
Germany	Klinikum Bamberg	Bamberg	Bayern
Germany	Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen	München	Bayern
Germany	Krankenhaus Peißenberg	Peißenberg	Bayern

Sponsors (4)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen	Klinikum Bamberg, Krankenhaus Peißenberg, Medtronic

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Occurrence of atrial tachyarrhythmias		3 months
Primary	Right ventricular pacing percentage		3 months
Secondary	BNP levels		3 months