His Bundle Pacing in Bradycardia and Heart Failure

NCT03008291 | Recruiting

• 1 other identifier: 16-005100
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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; Procedure: CRT-P Implantation

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

Interventions

CRT-D Implantation PROCEDURE

Cardiac resynchronization therapy defibrillator

Heart Failure Group

CRT-P Implantation PROCEDURE

Cardiac resynchronization therapy pacemaker

Heart Failure Group

Dual Chamber Pacemaker Implantation PROCEDURE

Atrioventricular Block/Bradycardia Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Age \< 18 years
• Pregnant

Sponsors & Collaborators

• Yong-Mei Cha: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Bradycardia; Heart Failure

Condition Hierarchy (Ancestors)

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

Study Officials

• Yong-Mei Cha, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong-Mei Cha, M.D.

CONTACT

(507) 255-2440; ycha@mayo.edu

Brent W Quam

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D., Professor of Medicine

Study Record Dates

• First Submitted: November 2, 2016
• First Posted: January 2, 2017
• Study Start: October 1, 2016
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)