IRB Study Number 23-718
Status Recruiting
Phase Not Applicable
Institute Heart and Vascular Institute
Description
Between 2013 and 2016, an estimated 6.2 million Americans over the age of 20 years had Heart Failure(HF). Nearly half of individuals with HF have a reduced ejection fraction (HFrEF). HF can slow the electrical signals of the heart, causing an irregular rhythm. One standard therapy for individuals with HFrEF is Cardiac-Resynchronization Therapy (CRT), by use of an Implantable Cardioverter Defibrillator (ICD) device, which can detect an irregular heart rhythm, and send electrical signals to restore it back to normal. ICDs achieve this by Biventricular Pacing (BiVP), which delivers these electrical signals to heart in two locations- the lower right ventricle, and the wall of the left ventricle. However, in roughly 20-30% of HF patients, BiVP did not improve their condition.
This study seeks to compare the safety and effectiveness of His/Left Bundle Branch Pacing (His/LBBP) to the standard BiVentricular Pacing in individuals with HFrEF. His/LBBP pacing still utilizes an ICD to detect and correct an irregular heart rhythm, but the electrical signals are sent to the heart in two different locations to BiVP- the His Bundle and the Left Bundle Branch (LBB), which are more centralized in the heart. The goal for this study is to find evidence that His/LBBP is just as or more so effective and safe as BiVP, so that His/LBBP can be used as an alternative therapy in heart failure patients.
Inclusion Criteria
Individuals who are able to be considered for participation in this study:
1.Must be 18 years old or older.
2.Must have a Left Ventricle Ejection fraction (LVEF) of ≤ 50% for at least six months prior to enrollment to the study.
3.Have a resting QRS duration of ≥ 130ms, proven by a 12-lead EKG OR qualify for> 40% right ventricular pacing, OR currently has a device in place with > 40% right ventricular pacing.
4.Must be taking optimal heart failure medications according to HF guidelines, OR be willing to undergo a medication change to meet guidelines.
Exclusion Criteria
Individuals who are unable to be considered for participation in this study:
1.Individuals who are pregnant, lactating, or plan to become pregnant during the study.
2.Individuals with coronary disease who are likely to undergo coronary artery bypass surgery or percutaneous coronary intervention within the next 3 months, OR who have had one of said interventions 3 months prior to enrollment.
3.Individuals who have had a heart attack within 3 months prior to enrollment.
4, Individuals with reversible non-ischemic cardiomyopathy.
5.Individuals with Chagas disease, cardiac sarcoidosis or amyloidosis.
6.Individuals expected to receive a heart transplantation within 6 months of enrollment.
7.Individuals with severe valvular disease.
8.Individuals who have a life expectancy of less than 1 year.
9.Individuals with irreversible brain damage.
10.Individuals with a contrast dye allergy or who cannot undergo a steroid treatment.
11.Individuals participating in other cardiovascular studies.
12.Individuals who are unable to comply with the study's follow up visit schedule.
13.Individuals who have had any prior unsuccessful attempt at implantation of a ICD device.
