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

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ClinicalTrials.gov Identifier: NCT01803217
Recruitment Status : Completed
First Posted : March 4, 2013
Last Update Posted : April 10, 2017
Sponsor:
Collaborators:
Klinikum Bamberg
Krankenhaus Peißenberg
Medtronic
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen

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.


Condition or disease Intervention/treatment Phase
Pacemaker Implantation for Sinus Node Disease Other: pacemaker programming to mode switch to atrial pacing versus atrioventricular hysteresis function Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: AV-Hysteresis Versus Mode Switch to AAI (MVP) for the Avoidance of Unnecessary Right Ventricular Pacing
Actual Study Start Date : November 2007
Actual Primary Completion Date : December 2011
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Right ventricular pacing percentage [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. BNP levels [ Time Frame: 3 months ]

Other Outcome Measures:
  1. Occurrence of atrial tachyarrhythmias [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01803217


Locations
Germany
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
Medtronic

Responsible Party: Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT01803217     History of Changes
Other Study ID Numbers: GER-EP-010
First Posted: March 4, 2013    Key Record Dates
Last Update Posted: April 10, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Sick Sinus Syndrome
Arrhythmia, Sinus
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Heart Block
Pathologic Processes