The Application of Negative Atrioventricular Hysteresis in Cardiac Resynchronization Therapy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02903940

Enrollment

Registered

2016-09-16

Start date

2016-12-31

Completion date

2022-12-31

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

Brief summary

The purpose of this study is to evaluate the application of Negative Atrioventricular Hysteresis (NAVH) to improve electrical synchrony in 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

* Implanted with a functioning 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

* CRT Pacing System implanted less than 1 week at time of enrollment * CRT Pacing System implanted more than 24 months at time of enrollment * CRT Pacing System implanted more than 90 days at time of enrollment AND intrinsic QRS duration is shorter than pre-implant intrinsic QRS duration by more than 10 ms * 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
Acute changes in surface ECG QRS duration resulting from Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis over a range of programmable values	1 day

Secondary

Measure	Time frame
Ambulatory changes in surface ECG QRS duration resulting from Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis	1 day

Countries

United States

Outcome results

None listed

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