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NCT Number: NCT03008291

His Bundle Pacing in Bradycardia and Heart Failure

Participants in this study will either have heart failure (HF) and are scheduled to undergo pace maker (PM) implantation, cardiac resynchronization therapy pacemaker (CRT-P), cardiac resynchronization therapy defibrillator (CRT-D) implantation, His bundle pacing (HIBP) or left bundle area pacing (LBAP) (including HIBP/LBAP for patients with HF, for patients who have failed CRT implant or patients who are CRT non-responders), or have atrioventricular (AV) block or bradycardia and are scheduled to undergo dual chamber pacemaker implantation. In this study additional heart rhythm measurements will be collected during the implant procedure to better understand how His bundle and/or parahisian pacing (HISP) effects electrical conduction in the hearts of patients with HF or AV block.

The hypothesis is that His bundle or parahisian pacing (HISP) and left bundle area pacing (LBAP) may normalize atrioventricular (AV) conduction with a narrow combination of the Q wave, R wave and S wave (QRS complex) in functional bundle branch block or conduction delay in patients with heart failure (HF).

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Key information

Conditions

Bradycardia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Heart Failure Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

HF Group

  • Clinically recommended to undergo PM, CRT-P, or CRT-D implantation or HIBP/LBAP (including HIBP/LBAP for patients with HF, for patients who have failed CRT implant or patients who are CRT non-responders)
  • Any QRS duration
  • LVEF ≤ 50%

AV Block/Bradycardia Group

  • Recommended to undergo dual chamber pacemaker implantation
  • Any AV block or Sinus Bradycardia

Exclusion criteria

  • Age < 18 years
  • Pregnant

Treatment and study plan

CRT-D implantation

Procedure

Cardiac resynchronization therapy defibrillator

CRT-P Implantation

Procedure

Cardiac resynchronization therapy pacemaker

Dual Chamber Pacemaker Implantation

Procedure

Primary outcomes

  1. QRS duration as measured by 12-lead ECG

    Time frame: Baseline to 6 months

    The normal duration (interval) of the QRS complex is 0.08 and 0.10 seconds (80 and 100 ms). When the duration is between 0.10 and 0.12 seconds it is intermediate or slightly prolonged. A QRS duration of greater than 0.12 seconds is considered abnormal.

  2. QRS morphology as measured by 12-lead ECG

    Time frame: Baseline to 6 months

    Normal QRS width is 70-100 ms (a duration of 110 ms is sometimes observed in healthy subjects). The QRS width is useful in determining the origin of each QRS complex (e.g. sinus, atrial, junctional or ventricular).

Study contacts

Contact information is provided by the study sponsor or research team.

Brent W Quam

CONTACT

[email protected]

507-422-3235

Yong-Mei Cha, M.D.

CONTACT

[email protected]

(507) 255-2440

Sponsors and collaborators

Lead sponsor

Yong-Mei Cha

Other

Registry information

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
Jan 2, 2017
Registry last updated
Dec 24, 2025

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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