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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02782598

Enrollment

Registered

2016-05-25

Start date

2016-06-30

Completion date

2020-05-31

Last updated

2024-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Negative, Atrioventricular, Hysteresis, Cardiac Resynchronization, MultiPoint

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.

Interventions

DEVICECRT+NAVH

Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Acute change in QRS duration due to CRT with NAVH, relative to intrinsic conduction	1 day	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

Measure	Time frame	Description
Acute changes in LV pressure-volume hemodynamics due to CRT with NAVH, relative to intrinsic conduction	1 day	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	1 day	Changes in surface ECG QRS duration after one day of Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026