Direct HIS/LBB Pacing vs. Conventional CRT in Symptomatic Heart Failure Patients with LBBB
This study aims to compare the effectiveness of Direct HIS/LBB Pacing and conventional Cardiac Resynchronization Therapy in symptomatic heart failure patients with Left Bundle Branch Block, by evaluating the change in Left ventricular end-systolic volume after 6 months and the success rate of implanting a HIS-bundle or LBB lead.
HIS/LBB pacing
+ LV pacing
Cardiac Conduction System Disease+6
+ Arrhythmias, Cardiac
+ Bundle-Branch Block
Treatment Study
Summary
Study start date: December 1, 2023
Actual date on which the first participant was enrolled.This study focuses on heart failure patients who have a condition called Left Bundle Branch Block, despite receiving the best medical treatments. These patients usually receive a type of treatment called biventricular pacing, but it has some drawbacks. The study is exploring a new approach called Direct HIS/Left Bundle Branch (LBB) pacing, which could potentially provide better results. The goal is to see if this new method can improve heart function and overcome the challenges of the current treatment, possibly offering a new solution for heart failure patients with this specific condition. In this single-center study, 125 patients are randomly assigned to either the conventional treatment (CRT) group or the new Direct HIS/LBB pacing group. For those in the new treatment group, Direct HIS-pacing is tried first. If it's not possible or the pacing threshold is too high, a Left Bundle Branch lead is used instead. The study measures the success of the treatment by looking at the decrease in left ventricular systolic volume after 6 months, and the success rate of implanting a pacing lead. The study also ensures that the new treatment is not worse than the current one by more than 10%.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Patients over 18 years of age, ischemic or non-ischemic cardiomyopathy with LVEF ≤ 35% assessed by echocardiography, NYHA class II-IV heart failure symptoms despite optimal medical treatment and * Either planned new implantation of a biventricular pacing system (CRT-P or CRT-D), where the ECG is with sinus rhythm and a typical left bundle branch block (see definition below) * Or planned upgrade of an existing pacemaker or ICD to a biventricular pacing system (CRT-P or CRT-D), where the ECG is with sinus rhythm and a typical left bundle branch block or there has been\> 90% right ventricular pacing from an existing pacemaker for at least 2 months prior to enrollment * Signed informed consent * Typical left bundle branch block: * QRS width \> 130 msec for women and \> 140 msec for men QS or rS pattern in leads V1 and V2, and mid-QRS plateau phase with or without extras in at least 2 of leads V1, V2, V5, V6, I, and aVL Exclusion Criteria: * Existing biventricular pacing system * Permanent atrial fibrillation * Severe renal failure with eGFR \< 30 ml/min * AMI or CABG within the last three months * The patient does not want to participate
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location