search
Back to results

The Application of Negative Atrioventricular Hysteresis in Cardiac Resynchronization Therapy With MultiPoint Pacing

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Italy
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 focused on measuring Negative, Atrioventricular, Hysteresis, Cardiac Resynchronization, MultiPoint

Eligibility Criteria

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

Inclusion Criteria:

  • Scheduled for implantation of an MPP-enabled 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:

  • 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

  • I.R.C.C.S. Policlinico San Donato

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CRT+NAVH

Arm Description

Surface ECG and pressure-volume loop recordings will be taken during the adjustment of programmable Cardiac Resynchronization Therapy and Negative Atrioventricular Hysteresis settings at the device implant procedure

Outcomes

Primary Outcome Measures

Acute change in QRS duration due to CRT with NAVH, relative to intrinsic conduction
Acute changes in surface ECG QRS duration resulting from Cardiac Resynchronization Therapy (CRT) with Negative Atrioventricular Hysteresis (NAVH) over a range of programmable values

Secondary Outcome Measures

Acute changes in LV pressure-volume hemodynamics due to CRT with NAVH, relative to intrinsic conduction
Acute changes in left ventricular pressure-volume hemodynamics resulting from Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis over a range of programmable values
Change in QRS duration after one day of CRT with NAVH, relative to intrinsic conduction
Changes in surface ECG QRS duration after one day of Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis

Full Information

First Posted
May 19, 2016
Last Updated
July 7, 2020
Sponsor
Abbott Medical Devices
search

1. Study Identification

Unique Protocol Identification Number
NCT02782598
Brief Title
The Application of Negative Atrioventricular Hysteresis in Cardiac Resynchronization Therapy With MultiPoint Pacing
Official Title
The Application of Negative Atrioventricular Hysteresis in Cardiac Resynchronization Therapy With MultiPoint Pacing
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
May 2020 (Actual)
Study Completion Date
May 2020 (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
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the application of Negative AV Hysteresis (NAVH) to improve electrical synchrony in MultiPoint Pacing (MPP) 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
Keywords
Negative, Atrioventricular, Hysteresis, Cardiac Resynchronization, MultiPoint

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
CRT+NAVH
Arm Type
Experimental
Arm Description
Surface ECG and pressure-volume loop recordings will be taken during the adjustment of programmable Cardiac Resynchronization Therapy and Negative Atrioventricular Hysteresis settings at the device implant procedure
Intervention Type
Device
Intervention Name(s)
CRT+NAVH
Intervention Description
Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis
Primary Outcome Measure Information:
Title
Acute change in QRS duration due to CRT with NAVH, relative to intrinsic conduction
Description
Acute changes in surface ECG QRS duration resulting from Cardiac Resynchronization Therapy (CRT) with Negative Atrioventricular Hysteresis (NAVH) over a range of programmable values
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Acute changes in LV pressure-volume hemodynamics due to CRT with NAVH, relative to intrinsic conduction
Description
Acute changes in left ventricular pressure-volume hemodynamics resulting from Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis over a range of programmable values
Time Frame
1 day
Title
Change in QRS duration after one day of CRT with NAVH, relative to intrinsic conduction
Description
Changes in surface ECG QRS duration after one day of 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: Scheduled for implantation of an MPP-enabled 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: 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
I.R.C.C.S. Policlinico San Donato
City
San Donato Milanese
State/Province
MI
ZIP/Postal Code
20097
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

The Application of Negative Atrioventricular Hysteresis in Cardiac Resynchronization Therapy With MultiPoint Pacing

We'll reach out to this number within 24 hrs