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
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Negative, Atrioventricular, Hysteresis, Cardiac Resynchronization, MultiPoint
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
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
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
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