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).

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Bradycardia
• Intervention / Treatment: Procedure: CRT-D Implantation; Procedure: CRT-P Implantation; Procedure: Dual Chamber Pacemaker Implantation

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Yong-Mei Cha, M.D.; Phone Number: (507) 255-2440; Email: ycha@mayo.edu
• Study Contact Backup: Name: Brent W Quam; Phone Number: 507-422-3235; Email: quam.brent@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
      • Principal Investigator: Yong-Mei Cha
      • Contact: Yong-mei Cha; Phone Number: (507) 255-2440; Email: ycha@mayo.edu
      • Contact: Brent Quam; Phone Number: 507-422-3235; Email: Quam.Brent@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from the heart clinic at Mayo Clinic in Rochester, Minnesota.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.)	Procedure: CRT-D Implantation; Cardiac resynchronization therapy defibrillator; Procedure: CRT-P Implantation; Cardiac resynchronization therapy pacemaker
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.)	Procedure: Dual Chamber Pacemaker Implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
QRS duration as measured by 12-lead ECG	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.	Baseline to 6 months
QRS morphology as measured by 12-lead ECG	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).	Baseline to 6 months

Collaborators and Investigators

• Sponsor: Yong-Mei Cha
• Investigators: Principal Investigator: Yong-Mei Cha, M.D., Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 2, 2016
• First Submitted That Met QC Criteria: December 30, 2016
• First Posted (Estimated): January 2, 2017

Study Record Updates

• Last Update Posted (Estimated): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Heart Failure; Bradycardia
• Other Study ID Numbers: 16-005100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No