Clinical Investigation Plan for the AVOPT Data Collection Clinical Study

Clinical Investigation Plan for the AVOPT Data Collection

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.

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)