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Clinical Investigation Plan for the AVOPT Data Collection Clinical Study | Clinical Trials | Clareo Health

COMPLETEDNA

Clinical Investigation Plan for the AVOPT Data Collection Clinical Study

Clinical Investigation Plan for the AVOPT Data Collection

NCT03049722•Biotronik Canada Inc

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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)

Locations (2)

Rouge Valley Centenary

Scarborough Village, Ontario, Canada

CHUS - Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Key Dates

Start Date

February 1, 2015

Primary Completion Date

October 1, 2016

Completion Date

February 1, 2017

Last Updated

February 10, 2017

Enrollment

ACTUAL participants

Conditions

Cardiac Pacemaker, Artificial

Interventions

Pacemaker

DEVICE

BIO|MASTER.CSP Study

NCT06620237

Cardiac Pacing, ArtificialCardiac Pacemaker, Artificial+5 more

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TERMINATEDNA

Optimize RV Selective Site Pacing Clinical Trial

NCT00422669

Cardiac Pacing, ArtificialCardiac Pacemaker, Artificial

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 10, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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