Ventricular Pace Suppression Study
Overview
Investigation of the efficacy and safety of the Ventricular Pace Suppression (VpS) algorithm.
Full Title of Study: “Ventricular Pace Suppression Study With the EVIA/ENTOVIS DR-T/DR Pacemaker”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Supportive Care
- Masking: Single (Participant)
- Study Primary Completion Date: September 2011
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.
Interventions
- 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.
Arms, Groups and Cohorts
- Other: Ventricular Pace Suppression- ON
- Other: Ventricular Pace Suppression- OFF
Clinical Trial Outcome Measures
Primary Measures
- Reduction of right ventricular pacing with the help of the VpS algorithm in the EVIA/ ENTOVIS pacemakers.
- Time Frame: 6-8 months
Secondary Measures
- A Complication free rate >95%, with respect to the VpS feature of the implanted pacemaker.
- Time Frame: 6-8 months
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: N/A
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Biotronik SE & Co. KG
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Hendrik Bonnemeier, Prof. Dr., Principal Investigator, Klinik für Kardiologie und Angiologie, UNIVERSITÄTSKLINIKUM Schleswig-Holstein, Campus Kiel
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.