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.

Study Overview

• Status: Completed
• Conditions: Cardiac Pacemaker, Artificial
• Intervention / Treatment: Device: Pacemaker

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Scarborough, Ontario, Canada, M1E 4B9
      • Rouge Valley Centenary
  • Quebec
    • Sherbrooke, Quebec, Canada
      • CHUS - Centre hospitalier universitaire de Sherbrooke

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AVOPT Patient	Device: Pacemaker

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation analysis between measured PWD and optimal AVD.	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.	Up to 6 hours

Collaborators and Investigators

• Sponsor: Biotronik Canada Inc

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: March 14, 2016
• First Submitted That Met QC Criteria: February 9, 2017
• First Posted (Actual): February 10, 2017

Study Record Updates

• Last Update Posted (Actual): February 10, 2017
• Last Update Submitted That Met QC Criteria: February 9, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: AVOPT