Left vs Left Randomized Clinical Trial

Overview

About this study

The purpose of this study is to prospectively test the comparative effectiveness of His or Left bundle branch pacing in relation to patient centered outcomes (quality of life, physical activity, heart failure hospitalization, mortality) and comparative safety in relation to device-related complications and re-interventions (e.g., lead dislodgement, infection) relative to standard of care biventricular pacing in patients with heart failure due to left ventricular systolic dysfunction (LVEF≤50%) and with either a wide QRS (≥130 ms) or with/anticipated >40% pacing who are already receiving current standard heart failure pharmacological therapy.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Men and women 18 years of age or older.

- A LVEF ≤ 50% within 6 months prior to enrollment.

- Resting QRS duration ≥130 ms as evidenced by a historical 12-lead ECG prior to
enrollment OR anticipated right ventricular pacing >40% OR device in place with right
ventricular pacing > 40%.

- Are optimized on HF guideline directed medical therapy according to current HF
published guidelines.

Exclusion Criteria:

- Women who are pregnant, lactating, or plan to become pregnant during the course of the
trial.

- Participants with angiographic evidence of coronary disease who are candidates for
coronary revascularization and are likely to undergo coronary artery bypass graft
surgery or percutaneous coronary, intervention in the next three (3) months.

- Enzyme-positive myocardial infarction within the past three (3) months prior to
enrollment.

- Coronary artery bypass graft surgery or percutaneous coronary intervention (balloon
and/or stent angioplasty) within the past three (3) months prior to enrollment.

- Reversible non-ischemic cardiomyopathy (e.g., acute viral myocarditis).

- Participants with Chagas disease, cardiac sarcoidosis or amyloidosis.

- Expected to receive left ventricular assist device or heart transplantation within 6
months.

- Participants with severe valvular disease (e.g., aortic stenosis).

- Have a life expectancy of less than 12 months.

- Participants with irreversible brain damage from preexisting cerebral disease.

- Participants with a contrast dye allergy unable or unwilling to undergo pretreatment
with steroids and/or diphenhydramine.

- Participants participating in any other interventional cardiovascular clinical trial.

- Participants who would be unable to return for follow-up visits due to the distance
from the clinic.

- Participants who do not anticipate being a resident of the area for the scheduled
duration of the trial.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 3/27/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Yongmei Cha, M.D.	Open for enrollment	Contact information: CVRU Heart Rhythm Services Research Team (507) 255-0774

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Yongmei Cha, M.D.

Open for enrollment

Contact information:

CVRU Heart Rhythm Services Research Team

(507) 255-0774

More information

Publications

Publications are currently not available

Clinical Trials