Assessment of Pacing Stimulus Conduction and Latency Meas... | NCT03314675

Studies
Assessment of Pacing Stimulus Conduction and Latency Measurements in CRT-D Patients

NCT03314675

Sponsor

Biotronik SE & Co. KG

Status

Terminated

Last Update Posted

Nov 28, 2018Actual

Enrollment

16Actual

Phase

Not Applicable

Conditions

Heart Failure

Interventions

BIOTRONIK CRT-D

Countries

Czechia
Germany
Netherlands

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

Nov 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Unsuccessful enrollment

Expanded Access Info

Start Date

Feb 26, 2018Actual

Primary Completion Date

Jun 28, 2018Actual

Completion Date

Jul 6, 2018Actual

First Submitted Date

Oct 16, 2017

First Submission Date that Met QC Criteria

Oct 16, 2017

First Posted Date

Oct 19, 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

Nov 27, 2018

Last Update Posted Date

Nov 28, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study is designed to collect data on LV latency in CRT-D patients by the CRT-D and compare measurements to 12-lead ECG data

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

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CRT-D Measurements	Other	Pre-specified measurements and additional follow-ups	Device: BIOTRONIK CRT-D

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BIOTRONIK CRT-D	Device	Pre-specified follow-up and measurements	CRT-D Measurements

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of patients with LV latency >/= 40ms (stimulus to QRS onset) with respect to the total number of screened patients		1 day

Secondary Outcomes

Measure	Description	Time Frame
Device-base measured LV latency in the LV IEGM channel and Far Field channel		1 day
12-lead ECG-measured LV latency in the channel with earliest QRS onset		1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient has been implanted with a CRT-D device by BIOTRONIK at least 4 weeks before enrollment date
Patient successfully implanted with a left ventricular lead
High likelihood of LV latency ≥ 40 ms
LV lead in lateral or postero-lateral position in the coronary venous system
Patient is able to understand the nature of the clinical investigation
Patient is willing to undergo the required measurements at the investigation site
Patient provides written informed consent
Age ≥ 18 years

Exclusion Criteria:

Patients with irregular ventricular rhythm due to atrial tachycardia
Pregnant or breast-feeding women
Participation in an interventional clinical investigation

Accepts Healthy Volunteers

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

Name	Affiliation	Role
Peter Nordbeck, PD Dr.	Wuerzburg University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ceske Budejovice hospital		České Budějovice		37001	Czechia
Institute for Clinical and Experimental Medicine

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided