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

Plain Language Summary

Simplified for easier understanding

This study is testing a type of pacemaker implantation called His bundle pacing or left bundle area pacing — which tries to use the heart's own natural wiring system — in patients with heart failure or slow heart rhythms, to see if it works better than traditional pacing methods. **You may be eligible if...** - You have heart failure and your doctor recommends a pacemaker or cardiac resynchronization device (CRT), OR you previously had a CRT that did not work well - You have a slow heart rate (bradycardia) or a type of heart block (the electrical signal in the heart is delayed or blocked), and need a pacemaker - Your heart pumping function is at or below 50% (for the heart failure group) - You are 18 years of age or older **You may NOT be eligible if...** - You are under 18 years of age - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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