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Ventricular Pace Suppression Study (VpS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01053832
First Posted: January 21, 2010
Last Update Posted: October 25, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Biotronik SE & Co. KG
  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
Intervention Model: Crossover Assignment
Masking: Single (Participant)
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 ]

Secondary Outcome Measures:
  • A Complication free rate >95%, with respect to the VpS feature of the implanted pacemaker. [ Time Frame: 6-8 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
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): 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

Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT01053832     History of Changes
Other Study ID Numbers: 45
First Submitted: January 19, 2010
First Posted: January 21, 2010
Last Update Posted: October 25, 2011
Last Verified: October 2011

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