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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Klinikum Bamberg
Krankenhaus Peißenberg
Medtronic
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT01803217
First received: February 28, 2013
Last updated: March 1, 2013
Last verified: February 2013
  Purpose

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Deutsches Herzzentrum Muenchen
ClinicalTrials.gov 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

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

ClinicalTrials.gov processed this record on August 28, 2014