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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
History of Changes
  Purpose

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


Condition Intervention
Pacemaker Indication
 Device: VpS algorithm in EVIA and ENTOVIS pacemakers

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Ventricular Pace Suppression Study With the EVIA/ENTOVIS DR-T/DR Pacemaker

Further study details as provided by Biotronik SE & Co. KG:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 84
Study Start Date: January 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Ventricular Pace Suppression- ON 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- OFF 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.

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01053832

Locations
Germany
Klinikum Coburg gGmbH
Coburg, Bavaria, Germany, 96450
Abteilung für Elektrophysiologie, Klinik für Kardiologie und Angiologie, UNIVERSITÄTSKLINIKUM Schleswig-Holstein
Kiel, Schleswig-Holstein, Germany, 24105
Sponsors and Collaborators
Biotronik SE & Co. KG
Investigators
Principal Investigator: Hendrik Bonnemeier, Prof. Dr. Klinik für Kardiologie und Angiologie, UNIVERSITÄTSKLINIKUM Schleswig-Holstein, Campus Kiel
  More Information

No publications provided

Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT01053832     History of Changes
Other Study ID Numbers: 45
Study First Received: January 19, 2010
Last Updated: October 24, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Biotronik SE & Co. KG:
ventricular pace suppression
pacemaker
efficacy
safety
support of intrinsic heart rhythm

ClinicalTrials.gov processed this record on May 23, 2013