Pacemaker Indication
Conditions
Keywords
ventricular pace suppression, pacemaker, efficacy, safety, support of intrinsic heart rhythm
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.
Interventions
DEVICEVpS 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.
Sponsors
Biotronik SE & Co. KG
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of right ventricular pacing with the help of the VpS algorithm in the EVIA/ ENTOVIS pacemakers. | 6-8 months |
Secondary
| Measure | Time frame |
|---|---|
| A Complication free rate >95%, with respect to the VpS feature of the implanted pacemaker. | 6-8 months |
Countries
Germany
Outcome results
None listed