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OpenTrials
Completed

NCT Number: NCT02782598

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

I.R.C.C.S. Policlinico San Donato

San Donato Milanese, MI, 20097, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CRT+NAVH

Device

Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis

Primary outcomes

  1. Acute change in QRS duration due to CRT with NAVH, relative to intrinsic conduction

    Time frame: 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 outcomes

  1. Acute changes in LV pressure-volume hemodynamics due to CRT with NAVH, relative to intrinsic conduction

    Time frame: 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

  2. Change in QRS duration after one day of CRT with NAVH, relative to intrinsic conduction

    Time frame: 1 day

    Changes in surface ECG QRS duration after one day of Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
May 25, 2016
Registry last updated
Jan 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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