His Bundle Pacing in Bradycardia and Heart Failure

Recruiting

• Conditions: Heart Failure; Bradycardia
• Interventions: Procedure: Dual Chamber Pacemaker Implantation; Procedure: CRT-D Implantation; Procedure: CRT-P Implantation

• Registration Number: NCT03008291
• Lead Sponsor: Yong-Mei Cha

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-11-02
• Study First Submitted QC: 2016-12-30
• Study First Posted: 2017-01-02
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-26
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Heart Failure Group	CRT-P Implantation	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	Dual Chamber Pacemaker Implantation	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.)
Heart Failure Group	CRT-D Implantation	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.)

Primary Outcome Measures

Name	Time	Method
QRS morphology as measured by 12-lead ECG	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).
QRS duration as measured by 12-lead ECG	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.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States