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The Application of Negative Atrioventricular Hysteresis in Cardiac Resynchronization Therapy

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CRT+NAVH
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cleveland Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CRT+NAVH

Arm Description

Surface ECG recordings will be taken during the adjustment of programmable Cardiac Resynchronization Therapy and Negative Atrioventricular Hysteresis settings.

Outcomes

Primary Outcome Measures

Acute changes in surface ECG QRS duration resulting from Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis over a range of programmable values

Secondary Outcome Measures

Ambulatory changes in surface ECG QRS duration resulting from Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis

Full Information

First Posted
September 13, 2016
Last Updated
January 30, 2023
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT02903940
Brief Title
The Application of Negative Atrioventricular Hysteresis in Cardiac Resynchronization Therapy
Official Title
The Application of Negative Atrioventricular Hysteresis in Cardiac Resynchronization Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
October 2022 (Actual)
Study Completion Date
December 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CRT+NAVH
Arm Type
Experimental
Arm Description
Surface ECG recordings will be taken during the adjustment of programmable Cardiac Resynchronization Therapy and Negative Atrioventricular Hysteresis settings.
Intervention Type
Device
Intervention Name(s)
CRT+NAVH
Intervention Description
Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis
Primary Outcome Measure Information:
Title
Acute changes in surface ECG QRS duration resulting from Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis over a range of programmable values
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Ambulatory changes in surface ECG QRS duration resulting from Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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The Application of Negative Atrioventricular Hysteresis in Cardiac Resynchronization Therapy

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