The Application of Negative Atrioventricular Hysteresis in Cardiac Resynchronization Therapy

Completed

• Conditions: Heart Failure
• Interventions: Device: CRT+NAVH

• Registration Number: NCT02903940
• Lead Sponsor: Abbott Medical Devices

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-13
• Study First Submitted QC: 2016-09-13
• Study First Posted: 2016-09-16
• Study Start: 2016-12
• Primary Completion: 2022-10
• Study Completion: 2022-12
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-08
• Last Update Posted: 2024-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CRT+NAVH	CRT+NAVH	Surface ECG recordings will be taken during the adjustment of programmable Cardiac Resynchronization Therapy and Negative Atrioventricular Hysteresis settings.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States