His Bundle Pacing in Bradycardia and Heart Failure

Heart Failure Clinical Trial

Official title:

His Bundle Pacing in Bradycardia and Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03008291
• Other study ID #: 16-005100
• Status: Recruiting
• Start date: October 2016
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: Mayo Clinic
• Contact: Yong-Mei Cha, M.D.
• Phone: (507) 255-2440
• Email: ycha[@]mayo.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

• Second or third degree AV block or Sinus Bradycardia

Exclusion Criteria:

• Age < 18 years

• Pregnant

Related Conditions & MeSH terms

• Bradycardia
• Heart Failure

Intervention

Procedure:
• CRT-D Implantation
Cardiac resynchronization therapy defibrillator
• CRT-P Implantation
Cardiac resynchronization therapy pacemaker
• Dual Chamber Pacemaker Implantation

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Yong-Mei Cha

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to 6 months
Primary	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).	Baseline to 6 months

External Links

•   Mayo Clinic Clinical Trials