Device-based QRS Evaluation | NCT02814214

Studies
Device-based QRS Evaluation

NCT02814214

Sponsor

Abbott Medical Devices

Status

Completed

Last Update Posted

Feb 4, 2019Actual

Enrollment

103Actual

Phase

Not provided

Conditions

Heart Failure

Interventions

ECG+IEGM

Countries

Italy

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

Jan 2019

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

Jun 2016Actual

Primary Completion Date

Aug 2017Actual

Completion Date

Sep 2017Actual

First Submitted Date

Jun 22, 2016

First Submission Date that Met QC Criteria

Jun 22, 2016

First Posted Date

Jun 27, 2016Estimated

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

Jan 31, 2019

Last Update Posted Date

Feb 4, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 purpose of this study is to collect simultaneous surface electrocardiogram (ECG) recordings and Cardiac Resynchronization Therapy (CRT) intracardiac electrogram (IEGM) recordings of variations in electrical synchrony.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

103Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ECG+IEGM		Surface ECG and intracardiac electrogram recordings will be taken during the adjustment of programmable Cardiac Resynchronization Therapy settings	Device: ECG+IEGM

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ECG+IEGM	Device	Cardiac Resynchronization Therapy programming adjustments	ECG+IEGM

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Characterize CRT IEGM-based estimations of QRS duration		Acute (1 day)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Already implanted with SJM Quadripolar CRT Pacing System
Ability to provide informed consent for study participation
Willing to comply with the study evaluation requirements
At least 18 years of age

Exclusion Criteria:

Resting ventricular rate >100 bpm
Intrinsic PR interval > 300 ms
Paroxysmal or persistent atrial tachycardia or atrial fibrillation documented
Pregnant or plans to become pregnant during the study

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

The study will include approximately 100 patients who have been implanted with SJM Quadripolar Pacing Systems

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
I.R.C.C.S. Policlinico San Donato		San Donato Milanese	MI	20097	Italy

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