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CompletedNCT02782598Updated Jan 10, 2024

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

An observational study in Heart Failure, sponsored by Abbott Medical Devices. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-10.

Sponsored by Abbott Medical Devices · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
17
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Heart Failure

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Keywords

  • Negative
  • Atrioventricular
  • Hysteresis
  • Cardiac Resynchronization
  • MultiPoint
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 17 is below the median of 200 across 1,679 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.

Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Enrollment will include patients scheduled to be implanted with MultiPoint Pacing-enabled SJM Quadripolar Pacing Systems

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
17 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

    Device: CRT+NAVH

Interventions

  • DeviceCRT+NAVH

    Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 day

Secondary outcomes

  1. 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

    Time frame: 1 day

  2. 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

    Time frame: 1 day

07

Study locations

1 site
  • I.R.C.C.S. Policlinico San Donato
    San Donato Milanese, MI 20097, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02782598
Lead sponsor
Abbott Medical Devices
Responsible party
Sponsor
First posted
May 25, 2016
Start date
Jun 2016
Primary completion
May 2020
Completion
May 2020
Last update
Jan 10, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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