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

Abbott Medical Devices17 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Heart Failure

Interventions

CRT+NAVHDEVICE

Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

I.R.C.C.S. Policlinico San Donato

San Donato Milanese, MI, Italy

Outcomes

Primary Outcomes

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

Time frame: 1 day

Secondary Outcomes

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

Time frame: 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

Time frame: 1 day

Data from ClinicalTrials.gov

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