His Bundle Pacing in Bradycardia and Heart Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CRT-D Implantation, CRT-P Implantation, Dual Chamber Pacemaker Implantation.
- Who it may be relevant to
- Registry conditions: Bradycardia, Heart Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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).
Interventions
- Procedure CRT-D Implantation
Cardiac resynchronization therapy defibrillator - Procedure CRT-P Implantation
Cardiac resynchronization therapy pacemaker - Procedure Dual Chamber Pacemaker Implantation
Primary outcome measures
- QRS duration as measured by 12-lead ECG [Time frame: Baseline to 6 months]
- QRS morphology as measured by 12-lead ECG [Time frame: Baseline to 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Mayo Clinic — Rochester
Identifiers
NCT: NCT03008291 · 16-005100