Ventricular Pace Suppression Study (VpS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT01053832
First received: January 19, 2010
Last updated: October 24, 2011
Last verified: October 2011

January 19, 2010
October 24, 2011
January 2010
September 2011   (final data collection date for primary outcome measure)
Reduction of right ventricular pacing with the help of the VpS algorithm in the EVIA/ ENTOVIS pacemakers. [ Time Frame: 6-8 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01053832 on ClinicalTrials.gov Archive Site
A Complication free rate >95%, with respect to the VpS feature of the implanted pacemaker. [ Time Frame: 6-8 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Ventricular Pace Suppression Study
Ventricular Pace Suppression Study With the EVIA/ENTOVIS DR-T/DR Pacemaker

Investigation of the efficacy and safety of the Ventricular Pace Suppression (VpS) algorithm.

The aim of this study is to investigate the percentage of reduction of ventricular pacing using the VpS feature of the EVIA/ENTOVIS pacemaker in a controlled clinical investigation.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Pacemaker Indication
Device: VpS algorithm in EVIA and ENTOVIS pacemakers
For one group of patients, the VpS algorithm will be activated and for the other group, the VpS algorithm will be deactivated until the cross-over, where these conditions will be switched.
  • Ventricular Pace Suppression- ON
    Intervention: Device: VpS algorithm in EVIA and ENTOVIS pacemakers
  • Ventricular Pace Suppression- OFF
    Intervention: Device: VpS algorithm in EVIA and ENTOVIS pacemakers
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
84
September 2011
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Paroxysmal AV block and/or Sinus Node Dysfunction
  • DDD(R)-ADI(R)-Mode (VpS Algorithm) applicability

Exclusion Criteria:

  • Permanent AV block III°
  • Permanent Atrial Fibrillation/ Flutter
  • Require mode other than DDD(R)-ADI(R) or DDD(R)
  • Have a life expectancy of less than six months
  • Expected to receive heart surgery within six months
  • Enrolled in another cardiac investigation
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01053832
45
Not Provided
Biotronik SE & Co. KG
Biotronik SE & Co. KG
Not Provided
Principal Investigator: Hendrik Bonnemeier, Prof. Dr. Klinik für Kardiologie und Angiologie, UNIVERSITÄTSKLINIKUM Schleswig-Holstein, Campus Kiel
Biotronik SE & Co. KG
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP