Clinical Investigation Plan for the AVOPT Data Collection Clinical Study

Biotronik

Status

Completed

Conditions

Cardiac Pacemaker, Artificial

Treatments

Device: Pacemaker

Study type

Interventional

Funder types

Industry

Identifiers

NCT03049722

AVOPT

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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)