The Application of Negative Atrioventricular Hysteresis in Cardiac Resynchronization Therapy

Abbott

Status: Completed

Conditions: Heart Failure

Treatments: Device: CRT+NAVH

Study type: Observational

Funder types: Industry

Identifiers

NCT02903940

CRD_855

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

30 participants in 1 patient group

CRT+NAVH

Description:

Surface ECG recordings will be taken during the adjustment of programmable Cardiac Resynchronization Therapy and Negative Atrioventricular Hysteresis settings.

Treatment:

Device: CRT+NAVH