His Bundle Pacing in Bradycardia and Heart Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorYong-Mei Cha
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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%
Recommended to undergo dual chamber pacemaker implantation
Disqualifiers
Age < 18 years
Pregnant
Trial population
Subjects will be recruited from the heart clinic at Mayo Clinic in Rochester, Minnesota.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
CRT-D Implantation
Procedure/SurgeryCardiac resynchronization therapy defibrillator
CRT-P Implantation
Procedure/SurgeryCardiac resynchronization therapy pacemaker
Dual Chamber Pacemaker Implantation
Procedure/Surgery
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Heart Failure Group2 interventions
Group B: Atrioventricular Block/Bradycardia Group1 intervention
Trial outcomes
Primary outcomes
1
QRS duration as measured by 12-lead ECG
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.
Time frame
Baseline to 6 months2
QRS morphology as measured by 12-lead ECG
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).
Time frame
Baseline to 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yong-Mei Cha
Lead sponsor
Mayo Clinic
Sponsor institution
Source ClinicalTrials.gov