Clinical Investigation Plan for the AVOPT Data Collection Clinical Study
Not Applicable
Completed
- Conditions
- Cardiac Pacemaker, Artificial
- Registration Number
- NCT03049722
- Lead Sponsor
- Biotronik Canada Inc
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Rouge Valley Centenary
🇨🇦Scarborough, Ontario, Canada
CHUS - Centre hospitalier universitaire de Sherbrooke
🇨🇦Sherbrooke, Quebec, Canada
Rouge Valley Centenary🇨🇦Scarborough, Ontario, Canada