Bradycardia, Heart Failure
Conditions
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).
Interventions
PROCEDURECRT-D Implantation
Cardiac resynchronization therapy defibrillator
PROCEDURECRT-P Implantation
Cardiac resynchronization therapy pacemaker
PROCEDUREDual Chamber Pacemaker Implantation
Sponsors
Yong-Mei Cha
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
Countries
United States
Contacts
Primary ContactYong-Mei Cha, M.D.
Backup ContactBrent W Quam
Outcome results
None listed