Cardiac Pacemaker, Artificial
Conditions
Brief summary
The purpose of this study is to collect clinical data for the development and evaluation of a new device feature for automatic AV-delay (AVD) optimization.
Interventions
DEVICEPacemaker
Sponsors
Biotronik Canada Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients implanted with an Evia DR(T) or Entovis DR(T) pacemaker * Possessing 1st or 3rd degree AV block * Implanted with Biotronik bipolar RA and RV leads * Implantation date should be at least 4 months prior to this study
Exclusion criteria
* Patient is a minor (18 years old or younger) * Patient is pregnant or breast-feeding * Patient does not have the legal capacity to provide consent * Patient has Mobitz type I or Mobitz type II heart block * Patient has persistent supraventricular tachycardia (including atrial fibrillation) or ectopic beats. * Patient is participating in other clinical studies during the clinical study * Patient is strictly pacemaker dependent (physician discretion)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation analysis between measured PWD and optimal AVD. | Up to 6 hours | Data analysis will be performed on the collected data to relate P wave duration (PWD) measured from the far field IEGM to the optimal AVD determined from the hemodynamic assessment. |
Countries
Canada
Outcome results
None listed