Recruiting

His Bundle Pacing

Sponsor:

Yong-Mei Cha

Code:

NCT03008291

Conditions

Bradycardia

Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CRT-D Implantation

CRT-P Implantation

Dual Chamber Pacemaker Implantation

Study Details

Brief summary:

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).

Conditions

Bradycardia

Heart Failure

Study ID

NCT03008291

Start date

Oct, 2016

Status verified date

Dec, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

Heart Failure Group

Patients who have any QRS duration and left ventricular ejection fraction (LVEF) ≤ 50% will be enrolled in this arm. The primary care physician will have recommended either PM, CRT-D Implantation, CRT-P Implantation, HIBP or LBAP (including HIBP/LBAP for patients with HF, for patients who have failed CRT implant or patients who are CRT non-responders) . (This is Standard of Care for this patient population; the procedures will occur even if the patient does not participate in the study.)

Atrioventricular Block/Bradycardia Group

Patients who have developed second or third degree atrioventricular block (AV block) or bradycardia will be enrolled in this arm. The primary care physician will have recommended dual chamber pacemaker implantation. (This is Standard of Care for this patient population; the procedures will occur even if the patient does not participate in the study.)

Interventions

CRT-D Implantation

Cardiac resynchronization therapy defibrillator

CRT-P Implantation

Cardiac resynchronization therapy pacemaker

Dual Chamber Pacemaker Implantation

Primary outcome measure

  • QRS duration as measured by 12-lead ECG [ Time Frame: Baseline to 6 months ]
  • QRS morphology as measured by 12-lead ECG [ Time Frame: Baseline to 6 months ]

Central Contacts and Locations

Central contacts

Yong-Mei Cha, M.D.

(507) 255-2440ycha@mayo.edu

Brent W Quam

507-422-3235quam.brent@mayo.edu

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Yong-mei Cha

(507) 255-2440ycha@mayo.edu

Brent Quam

507-422-3235quam.brent@mayo.edu

Principal Investigator:

Yong-Mei Cha

More Information

Sponsor

Yong-Mei Cha

Last update posted

Dec 24, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yong-Mei Cha on 2025-12-24.