Clinical Investigation Plan for the AVOPT Data Collection

Biotronik Canada Inc2 sites in 1 country30 target enrollmentFebruary 2015

ConditionsCardiac Pacemaker, Artificial

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cardiac Pacemaker, Artificial
Sponsor: Biotronik Canada Inc
Enrollment: 30
Locations: 2
Primary Endpoint: Correlation analysis between measured PWD and optimal AVD.
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2015

End Date

February 2017

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Biotronik Canada Inc

Responsible Party

Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Correlation analysis between measured PWD and optimal AVD.

Time Frame: 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.