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His Bundle Pacing for Bradycardia and Heart Failure

This study is looking at how His bundle pacing (HISP) affects the heart's electrical system in people with heart failure or certain heart rhythm problems (bradycardia or AV block). You might be able to join if you have heart failure with a reduced pumping ability (LVEF ≤ 50%) and are scheduled for a pacemaker, CRT-P (cardiac resynchronization therapy pacemaker), or CRT-D (cardiac resynchronization therapy defibrillator) implantation. You could also join if you have AV block or bradycardia and are scheduled for a dual chamber pacemaker. Researchers will collect extra heart rhythm measurements during your implant procedure to understand how HISP works. The main goals are to measure changes in your heart's electrical activity (QRS duration and morphology) over six months.

Study design
This is an observational study involving 80 participants. It is not specified if it is randomized or blinded.
What's involved
You will undergo additional heart rhythm measurements during your pacemaker or defibrillator implant procedure. Your heart's electrical activity will be measured at the start and then again at 6 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 months after their implant procedure to measure changes in heart rhythm.

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NCT03008291

His Bundle Pacing in Bradycardia and Heart Failure

Recruiting
Not specifiedAges 18+Observational
Yong-Mei Cha
~80 participants
Updated 2025-12-24 on ClinicalTrials.gov
What's tested:CRT-D ImplantationCRT-P ImplantationDual Chamber Pacemaker Implantation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
QRS duration as measured by 12-lead ECG
Measured over Baseline to 6 months
+1 more outcome measured

Conditions

Bradycardia
Heart Failure

Explore related trials

Atrioventricular Block by ECG FindingBradycardiaHeart Failure

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Yong-Mei Cha, M.D. · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Yong-Mei Cha, M.D.
[email protected]
(507) 255-2440
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

Age \< 18 years
Pregnant

What this trial measures

  • QRS duration as measured by 12-lead ECGBaseline 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.

  • QRS morphology as measured by 12-lead ECGBaseline 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).