Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2013 by Deutsches Herzzentrum Muenchen.
Recruitment status was  Active, not recruiting
Klinikum Bamberg
Krankenhaus Peißenberg
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen Identifier:
First received: February 28, 2013
Last updated: March 1, 2013
Last verified: February 2013

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.

Condition Intervention
Pacemaker Implantation for Sinus Node Disease
Other: pacemaker programming to mode switch to atrial pacing versus atrioventricular hysteresis function

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: AV-Hysteresis Versus Mode Switch to AAI (MVP) for the Avoidance of Unnecessary Right Ventricular Pacing

Resource links provided by NLM:

Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • Right ventricular pacing percentage [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • BNP levels [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Occurrence of atrial tachyarrhythmias [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 70
Study Start Date: November 2007
Estimated Study Completion Date: June 2013
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: mode switch to atrial pacing Other: pacemaker programming to mode switch to atrial pacing versus atrioventricular hysteresis function
Active Comparator: atrioventricular hysteresis function Other: pacemaker programming to mode switch to atrial pacing versus atrioventricular hysteresis function

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

  Contacts and Locations
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Please refer to this study by its identifier: NCT01803217

Klinikum Bamberg
Bamberg, Bayern, Germany, 96049
Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen
München, Bayern, Germany, 80636
Krankenhaus Peißenberg
Peißenberg, Bayern, Germany, 82380
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Klinikum Bamberg
Krankenhaus Peißenberg
  More Information

No publications provided

Responsible Party: Deutsches Herzzentrum Muenchen Identifier: NCT01803217     History of Changes
Other Study ID Numbers: GER-EP-010
Study First Received: February 28, 2013
Last Updated: March 1, 2013
Health Authority: Germany: Ethics Commission processed this record on February 25, 2015