RecruitingNCT03008291

His Bundle Pacing in Bradycardia and Heart Failure


Sponsor

Yong-Mei Cha

Enrollment

80 participants

Start Date

Oct 1, 2016

Study Type

OBSERVATIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • 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 Criteria2

  • Age \< 18 years
  • Pregnant

Interventions

PROCEDURECRT-D Implantation

Cardiac resynchronization therapy defibrillator

PROCEDURECRT-P Implantation

Cardiac resynchronization therapy pacemaker

PROCEDUREDual Chamber Pacemaker Implantation

Locations(1)

Mayo Clinic

Rochester, Minnesota, United States

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NCT03008291


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