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

Completed

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

• Registration Number: NCT02782598
• Lead Sponsor: Abbott Medical Devices

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-19
• Study First Submitted QC: 2016-05-24
• Study First Posted: 2016-05-25
• Study Start: 2016-06
• Primary Completion: 2020-05
• Study Completion: 2020-05
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-08
• Last Update Posted: 2024-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CRT+NAVH	CRT+NAVH	Surface ECG and pressure-volume loop recordings will be taken during the adjustment of programmable Cardiac Resynchronization Therapy and Negative Atrioventricular Hysteresis settings at the device implant procedure

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

I.R.C.C.S. Policlinico San Donato; 🇮🇹 San Donato Milanese, MI, Italy