The Application of Negative Atrioventricular Hysteresis i... | NCT02903940

Studies
The Application of Negative Atrioventricular Hysteresis in Cardiac Resynchronization Therapy

NCT02903940

Sponsor

Abbott Medical Devices

Status

Completed

Last Update Posted

Jan 10, 2024Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Heart Failure

Interventions

CRT+NAVH

Countries

United States

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 2024

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

Dec 2016Actual

Primary Completion Date

Oct 2022Actual

Completion Date

Dec 2022Actual

First Submitted Date

Sep 13, 2016

First Submission Date that Met QC Criteria

Sep 13, 2016

First Posted Date

Sep 16, 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 8, 2024

Last Update Posted Date

Jan 10, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the application of Negative Atrioventricular Hysteresis (NAVH) to improve electrical synchrony in Cardiac Resynchronization Therapy (CRT) patients.

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

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CRT+NAVH		Surface ECG recordings will be taken during the adjustment of programmable Cardiac Resynchronization Therapy and Negative Atrioventricular Hysteresis settings.	Device: CRT+NAVH

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CRT+NAVH	Device	Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis	CRT+NAVH

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Acute changes in surface ECG QRS duration resulting from Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis over a range of programmable values		1 day

Secondary Outcomes

Measure	Description	Time Frame
Ambulatory changes in surface ECG QRS duration resulting from Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis		1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Implanted with a functioning SJM Quadripolar CRT Pacing System
QRS duration > 140 ms
Left bundle branch block documented
Ability to provide informed consent for study participation
Willing to comply with the study evaluation requirements
At least 18 years of age

Exclusion Criteria:

CRT Pacing System implanted less than 1 week at time of enrollment
CRT Pacing System implanted more than 24 months at time of enrollment
CRT Pacing System implanted more than 90 days at time of enrollment AND intrinsic QRS duration is shorter than pre-implant intrinsic QRS duration by more than 10 ms
Resting ventricular rate >100 bpm
Intrinsic PR interval > 300 ms
Paroxysmal or persistent atrial tachycardia or atrial fibrillation documented
A recent myocardial infarction, ablation, drug intoxication, electrolyte imbalance, or any condition within the last 90 days that would be contraindicated for CRT programming changes in the opinion of the investigator
Women who are pregnant or who plan 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

Patients already implanted with SJM Quadripolar CRT Pacing Systems will be enrolled in the study

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Cleveland Clinic		Cleveland	Ohio	44195	United States

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

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases