Clinical Investigation Plan for the AVOPT Data Collection Clinical Study

Cardiac Pacemaker, Artificial Clinical Trial

Official title:

Clinical Investigation Plan for the AVOPT Data Collection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03049722
• Other study ID #: AVOPT
• Status: Completed
• Phase: N/A
• First received: March 14, 2016
• Last updated: February 9, 2017
• Start date: February 2015
• Est. completion date: February 2017

Study information

• Verified date: February 2017
• Source: Biotronik Canada Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cardiac Pacemaker, Artificial

Intervention

Device:
• Pacemaker

Locations

Country	Name	City	State
Canada	Rouge Valley Centenary	Scarborough	Ontario
Canada	CHUS - Centre hospitalier universitaire de Sherbrooke	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik Canada Inc

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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