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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02782598
• Other study ID #: CRD_856
• Status: Completed
• Start date: June 2016
• Est. completion date: May 2020

Study information

• Verified date: January 2024
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• CRT+NAVH
Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis

Locations

Country	Name	City	State
Italy	I.R.C.C.S. Policlinico San Donato	San Donato Milanese	MI

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute change in QRS duration due to CRT with NAVH, relative to intrinsic conduction	Acute changes in surface ECG QRS duration resulting from Cardiac Resynchronization Therapy (CRT) with Negative Atrioventricular Hysteresis (NAVH) over a range of programmable values	1 day
Secondary	Acute changes in LV pressure-volume hemodynamics due to CRT with NAVH, relative to intrinsic conduction	Acute changes in left ventricular pressure-volume hemodynamics resulting from Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis over a range of programmable values	1 day
Secondary	Change in QRS duration after one day of CRT with NAVH, relative to intrinsic conduction	Changes in surface ECG QRS duration after one day of Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis	1 day