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OpenTrials
Completed

NCT Number: NCT02903940

The Application of Negative Atrioventricular Hysteresis in Cardiac Resynchronization Therapy

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.

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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

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

CRT+NAVH

Device

Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis

Primary outcomes

  1. Acute changes in surface ECG QRS duration resulting from Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis over a range of programmable values

    Time frame: 1 day

Secondary outcomes

  1. Ambulatory changes in surface ECG QRS duration resulting from Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Sep 16, 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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