Clinical Investigation Plan for the AVOPT Data Collection... | NCT03049722

Studies
Clinical Investigation Plan for the AVOPT Data Collection Clinical Study

NCT03049722

Sponsor

Biotronik Canada Inc

Status

Completed

Last Update Posted

Feb 10, 2017Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Cardiac Pacemaker, Artificial

Interventions

Pacemaker

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015

Primary Completion Date

Oct 2016Actual

Completion Date

Feb 2017Actual

First Submitted Date

Mar 14, 2016

First Submission Date that Met QC Criteria

Feb 9, 2017

First Posted Date

Feb 10, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2017

Last Update Posted Date

Feb 10, 2017Actual

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Label	Type	Description	Intervention Names
AVOPT Patient	Experimental		Device: Pacemaker

Name	Type	Description	Arm Group Labels	Other Names
Pacemaker	Device		AVOPT Patient

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rouge Valley Centenary		Scarborough Village	Ontario	M1E 4B9	Canada
CHUS - Centre hospitalier universitaire de Sherbrooke