Ventricular Pace Suppression Study
Not Applicable
Completed
- Conditions
- Pacemaker Indication
- Interventions
- Device: VpS algorithm in EVIA and ENTOVIS pacemakers
- Registration Number
- NCT01053832
- Lead Sponsor
- Biotronik SE & Co. KG
- Brief Summary
Investigation of the efficacy and safety of the Ventricular Pace Suppression (VpS) algorithm.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Ventricular Pace Suppression- ON VpS algorithm in EVIA and ENTOVIS pacemakers - Ventricular Pace Suppression- OFF VpS algorithm in EVIA and ENTOVIS pacemakers -
- Primary Outcome Measures
Name Time Method Reduction of right ventricular pacing with the help of the VpS algorithm in the EVIA/ ENTOVIS pacemakers. 6-8 months
- Secondary Outcome Measures
Name Time Method A Complication free rate >95%, with respect to the VpS feature of the implanted pacemaker. 6-8 months
Trial Locations
- Locations (2)
Klinikum Coburg gGmbH
🇩🇪Coburg, Bavaria, Germany
Abteilung für Elektrophysiologie, Klinik für Kardiologie und Angiologie, UNIVERSITÄTSKLINIKUM Schleswig-Holstein
🇩🇪Kiel, Schleswig-Holstein, Germany