His-Bundle Corrective Pacing in Heart Failure

Launched by UNIVERSITY OF ROCHESTER · Feb 22, 2022

Keywords

ClinConnect Summary

The clinical trial titled "His-Bundle Corrective Pacing in Heart Failure" is investigating a new treatment approach for patients with heart failure who also have a condition called right bundle branch block (RBBB). The researchers want to see if a technique called His-bundle pacing, combined with standard cardiac resynchronization therapy (CRT), is more effective than the usual CRT alone. This study is currently recruiting participants aged 18 and older who are receiving the best medical treatment for their heart failure and meet specific criteria, such as having certain symptoms and heart function measurements.

If you qualify for this trial, you will undergo evaluations to confirm your eligibility and then receive either the new treatment or the standard therapy. Participants will be closely monitored throughout the study to understand how well each treatment works. It's important to note that this trial cannot accept individuals with certain heart conditions or those who are on a heart transplant list. Overall, this study aims to help improve treatment options for heart failure patients and enhance their quality of life.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18 years or older (no upper age limit)
• • Optimal medical therapy for heart failure by current guidelines
• * Class IIa or IIb guideline-based indication for CRT-D implant in RBBB patients, including one of the following:
• • New York Heart Association (NYHA) class II HF symptoms, LVEF ≤ 30% and QRS≥ 150 ms (IIb); OR
• • NYHA class III-IV a HF, LVEF ≤ 35%, and QRS duration ≥ 150 ms (IIa); OR
• • NYHA class III-IV a HF, LVEF ≤ 35%, and QRS duration 120-149 ms (IIb)
• Exclusion Criteria:
• • Unable to obtain most recent imaging data from echocardiogram within 1 year prior to date of randomization
• • Left bundle branch block (LBBB) or intraventricular conduction delay (IVCD) ECG morphology
• • Unable or unwilling to follow study protocol
• • Less than 12 months life expectancy at consent
• • Pregnancy or planned pregnancy during duration of the study
• • On heart transplant list or likely to undergo heart transplant