Ventricular Pace Suppression Study

Not Applicable

Completed

• Conditions: Pacemaker Indication

• 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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-19
• Study First Submitted QC: 2010-01-20
• Study First Posted: 2010-01-21
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-24
• Last Update Posted: 2011-10-25

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

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