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Bundle-Branch Block clinical trials

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NCT ID: NCT05654792 Not yet recruiting - Clinical trials for Transcatheter Aortic Valve Replacement

Prognostic Factors in NOP-LBBB After TAVI

ProgNOP-LBBB
Start date: December 10, 2022
Phase:
Study type: Observational

The goal of this observational study is to find prognostic factors in patients with a new-onset persistent left bundle branch block (NOP-LBBB) after transcatheter aortic valve implantation (TAVI). The main question it aims to answer is: Are there any factors influencing heart failure or death risk during the year following TAVI in patients with NOP-LBBB ? Participants will have data collection about TAVI procedure and clinical evolution during a one-year follow-up.

NCT ID: NCT05652218 Recruiting - Clinical trials for Left Bundle-Branch Block

REsynchronization Comparison In LBBB and Normal or Mildly Reduced VENTricular Function With CRT (REINVENT-CRT)

REINVENT
Start date: February 26, 2023
Phase: N/A
Study type: Interventional

Primary Objective - To determine if implantation of a permanent CRT pacing device (with LB-CRT, or conventional BiV-CRT with a coronary sinus LV lead) can improve electromechanical function, HF symptoms, and natriuretic peptide levels among patients with symptomatic HF, LVEF > 35%, and LBBB.

NCT ID: NCT05643404 Recruiting - Clinical trials for Left Bundle-Branch Block

Effects of Isolated LBBB on Maximal Functional Capacity

Start date: December 22, 2022
Phase:
Study type: Observational

Left bundle branch block (LBBB) has been commonly associated with adverse cardiovascular (CV) events, but the effect of an isolated LBBB on maximal functional capacity is not well characterized. The study's main objective is to evaluate the effect of LBBB on maximum functional capacity.

NCT ID: NCT05572957 Recruiting - Heart Failure Clinical Trials

LBBP as Initial Therapy in Patients With Non-ischemic Heart Failure and LBBB

LIT-HF
Start date: October 14, 2022
Phase: N/A
Study type: Interventional

The present study will recruit 50 symptomatic non-ischemic cardiomyopathy (NICM) patients with left ventricular ejection fraction (LVEF) below 35% and complete left bundle branch block (CLBBB), who have not received complete guideline-directed medical therapy (GDMT). Each patient was randomized to 2 groups, GDMT or left bundle branch pacing combined with GDMT (LBBP+GDMT) as initial therapy and was followed up for 2 phases: 0-6 months (phase I), 7-18 months (phase II). The primary objective is to compare the LVEF change , syncope and malignant ventricular arrhythmias between GDMT group and LBBP+GDMT group, and to observe which strategy will significantly reduce the percentage of recommendations for an implantable cardioverter-defibrillator (ICD) during phase I study. The second outcome measures including health economics, echocardiography parameters[left ventricular ejection fraction (LVEF), left ventricular end-systolic volume (LVESV), left ventricular end-diastolic volume (LVEDV)], N-terminal pro B-type natriuretic peptide (NT-proBNP) level, New York Heart Association (NYHA) class, 6-minute walking distance (6MWD), quality of life score(QOL) and incidence of clinical adverse events.

NCT ID: NCT05572736 Active, not recruiting - Heart Failure Clinical Trials

Conduction System Pacing Versus Biventricular Resynchronization in Patients With Chronic Heart Failure

PhysioSync-HF
Start date: November 7, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect of conduction system pacing versus biventricular pacing on death, worsening heart failure, and left ventricular ejection fraction in patients with chronic heart failure with reduced ejection fraction and left bundle branch block.

NCT ID: NCT05564689 Recruiting - Heart Failure Clinical Trials

Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy

FLOW-LBBB
Start date: September 29, 2022
Phase:
Study type: Observational

Cardiac resynchronization therapy (CRT) is an effective therapeutic strategy in patients with symptomatic heart failure (HF) patients with LVEF of ≤35% and left bundle branch block (LBBB). However, approximately one-third of CRT-recipients do not improve after therapy (non-responders), despite meeting the required criteria. Previous studies have documented that the positive respons to CRT is related to the delayed electrical activation of the left ventricle in patients with LBBB. It has also been illustrated that non-ischemic CRT-candidates with LBBB demonstrate lower regional myocardial blood flow and metabolism in the septum. Additionally, it has been suggested that LBBB can lead to impaired coronary blood flow in the left anterior descending artery (LAD). This observation is based on an echocardiography-based study, that showed that the percentage of diastolic flow duration (%DD) in LAD was shorter in patients with LBBB compared to the control-group and patients with right-ventricular pacing. It has been demonstrated that CRT has positive effects on septal myocardial perfusion in patients with HF and LBBB. The dominant hypothesis explaining this phenomenon is built on improved septal myocardial work after CRT-implantation, which leads to increased myocardial energy and therefore increased myocardial perfusion. In contrast, it has been suggested that due to re-established synchronous left ventricular electrical activation, CRT reduces the septal intramyocardial pressure in early diastole, leading to a relatively longer antegrade flow duration in LAD. Therefore, the aim of the study is to evaluate the effect of CRT on coronary blood flow in LAD in patients with non-ischemic HF and LBBB. The investigators hypothesize that increased LV-function after CRT not only is due to resynchronized LV ejection and filling, but also improved coronary flow. The study aims to enroll 60 patients with heart failure due to non-ischemic dilated cardiomyopathy, LBBB, with or without CRT. All patients meeting the criteria will be recruited from the outpatient clinic at the Department of Cardiology, Aalborg University Hospital. Invasive flow measurements in the LAD, including fractional flow reserve (FFR), absolute coronary flow and -reserve will be conducted with the CRT on and off, respectively.

NCT ID: NCT05519046 Recruiting - Heart Failure Clinical Trials

Cardiac Contractility Modulation in Chagas Heart Disease

FIX-Chagas
Start date: May 6, 2022
Phase: N/A
Study type: Interventional

Chagas disease is an endemic problem in Latin America, where millions of people are chronically infected with T. cruzi. Recently, it was assumed to have clinical and epidemiological relevance in several other countries due to migratory and globalizing social factors. CCC occurs in 30-50% of infected individuals, causing considerable morbidity/mortality rates. Heart failure is the most prevalent morbidity. While CRT and drug treatment have been advocated and implemented without much success to improve the clinical condition of patients with CCC, there is no consistent scientific evidence on the role of cardiac contractility modulation (CCM) as a form of adjuvant treatment for heart failure in patients with CCC. The hypothesis of this study is that patients with CCC, advanced heart failure, severe systolic dysfunction, and non-LBB have better clinical and functional responses when undergoing implantation of a CCM device than when undergoing cardiac resynchronization therapy.

NCT ID: NCT05434962 Recruiting - Heart Failure Clinical Trials

The Left Bundle Cardiac Resynchronization Therapy Trial

Start date: June 27, 2022
Phase: N/A
Study type: Interventional

Cardiac resynchronization therapy (CRT) via biventricular (BiV) pacing significantly reduces morbidity and mortality in patients with left bundle branch block (LBBB), impaired LV function and heart failure in spite of optimal medical treatment. CRT positive effects are based on the existence of an electromechanical dyssynchrony induced by the abnormal activation sequence associated with the presence of a left bundle branch block (LBBB), which is thought to be responsible for a negative LV remodeling leading to LVEF impairment and heart failure progression. However, one third of patients undergoing CRT are considered non responders due to different reasons. Recently, left bundle branch area pacing (LBBAP) has emerged as a novel physiological pacing modality aiming for conduction system recruitment in patients with normal or impaired atrioventricular conduction, including patients with LBBB. LBBAP achieves LBBB correction in up to 85% of the cases and thus could be a promising pacing modality for CRT candidates.

NCT ID: NCT05327062 Recruiting - Clinical trials for Chronic Heart Failure

Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment

CRT-DRIVE
Start date: March 6, 2023
Phase: N/A
Study type: Interventional

The objective of this prospective, multicenter controlled study is to assess the feasibility of a patient-tailored implantation by creating a cloud-based pre-procedural multimodality CRT-roadmap by integration of 3D images from 3D activation sequence from ECG, and coronary venous anatomy from cardiac computed tomography. This CRT-roadmap will be used to guide LV lead placement to a coronary vein in an electrically late-activated region. Study Hypothesis: At least 75% of patients undergoing a CRT implantation guided by non-invasive electrical and venous anatomy assessment (XSPLINE technology) will show a reduction of left ventricular end-systolic volume of 15% or more at 6-month evaluation.

NCT ID: NCT05283603 Recruiting - Clinical trials for Left Bundle Branch Block (LBBB) on ECG

Clinical Observational Registry of Patients With Left Bundle Branch Block

RECOrd-LBBB
Start date: July 31, 2019
Phase:
Study type: Observational [Patient Registry]

The electromechanical dyssynchrony induced by the presence of LBBB is in some patients, but not all, the cause of progressive left ventricular systolic dysfunction and heart failure. Aims 1. To investigate the clinical, ECG, imaging-derived features in a large cohort of patients affected by LBBB on ECG. 2. To identify predictors of LBBB-induced LV systolic dysfunction and predictors of outcome in this population. 3. To derive data which may have an impact on therapeutic management.