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

Study Overview
=================
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.

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

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: CRT+NAVH


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CRT+NAVH<br>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 | Device: CRT+NAVH<br>* Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 day | 
| 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 | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Negative, Atrioventricular, Hysteresis, Cardiac Resynchronization, MultiPoint