NCT03049722

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 10, 2017

Completed
Last Updated

February 10, 2017

Status Verified

February 1, 2017

Enrollment Period

1.7 years

First QC Date

March 14, 2016

Last Update Submit

February 9, 2017

Conditions

Cardiac Pacemaker, Artificial

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

AVOPT Patient

EXPERIMENTAL
Device: Pacemaker

Interventions

PacemakerDEVICE
AVOPT Patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rouge Valley Centenary

Scarborough Village, Ontario, M1E 4B9, Canada

Location

CHUS - Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2016

First Posted

February 10, 2017

Study Start

February 1, 2015

Primary Completion

October 1, 2016

Study Completion

February 1, 2017

Last Updated

February 10, 2017

Record last verified: 2017-02

Locations

CA(2)