His Bundle Pacing in Bradycardia and Heart Failure

Yong-Mei Cha

Status: Enrolling

Conditions: Bradycardia; Heart Failure

Treatments: Procedure: CRT-D Implantation; Procedure: CRT-P Implantation; Procedure: Dual Chamber Pacemaker Implantation

Study type: Observational

Funder types: Other

Identifiers

NCT03008291

16-005100

Details and patient eligibility

About

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).

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

80 participants in 2 patient groups

Heart Failure Group

Description:

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.)

Treatment:

Procedure: CRT-P Implantation

Procedure: CRT-D Implantation

Atrioventricular Block/Bradycardia Group

Description:

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.)

Treatment:

Procedure: Dual Chamber Pacemaker Implantation