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NCT Number: NCT06674967

Efficacy and Safety of Left Bundle Area Pacing Vs Right Ventricular Apical Pacing in Patients with Atrioventricular Block

This study will address whether LBBaP is superior to RVAP in terms of safety and efficacy

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

  • Cardiac pacing is an effective therapy for treating patients with bradycardia due to sinus node dysfunction or atrioventricular block. However, traditional right ventricular apical pacing (RVAP) causes electric and mechanical desynchrony, increasing the risk for atrial arrhythmias and heart failure.
  • .Cardiac resynchronization therapy(CRT)is another pacing modality employed for treatment of HF .Clinical studies have demonstrated that CRT promotes left ventricular reverse remodelling and reduces morbidity and mortality in patients with HF . Although CRT's benefits are well demonstrated, the therapy has been associated with significantly high non-response rate(30-40%).Also, the BVP is a non-physiological approach that requires two leads to activate the ventricular myocardium and not the specialized conduction system
  • Therefore, there is a need to develop a physiological pacing approach that provides synchronized contraction of the ventricles
  • Although His bundle pacing (HBP)has been widely used as a physiological pacing modality, it is limited by challenging implantation technique, unsatisfactory success rate in patients with wide QRS wave, high pacing capture threshold, and early battery depletion.
  • Recently, the left bundle branch pacing (LBBP), defined as the capture of the left bundle branch (LBB) via trans ventricular septal approach, has emerged as a new physiological pacing modality.
  • this approach has been found to provide physiological pacing that guarantees electrical synchrony of the left ventricle with a low pacing threshold.
  • LBBP implantation is done by The Select Secure lead (model 3830) and Select Site C315HisorC304His sheaths are used in operation, while an electrophysiological multichannel recorder is used to simultaneously document intracardiac EGMs and 12-lead ECG .the Pacing System Analyzer (PSA) is used to test the pacing parameters and record intracardiac EGMs. The operation process can be summarized as follows: (1) establishment of the venous access and determination of the initial LBBP site; (2) introducing a pacing lead into the right ventricle and screwing it into the interventricular septum(IVS) until it reached in the LBB areas;(3) assessing the lead depth into ventricular septum and confirming LBB capture; (4)removing the sheath and providing the slack; and(5)programming the pulse generator.
  • There is a limited number of clinical studies, featuring small sample sizes, that have shown that, compared with right ventricular apex pacing (RVAP), the QRS duration of postoperative ECG in LBBaP patients is narrower and the cardiac systolic function is improved. Also, there have been limited number of randomized controlled trials (RCTs) evaluating the efficacy and safety of LBBaP in patients with atrioventricular block (AVB) versus those with RVAP.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with AVB who meet indications for pacemaker
  • Implantation with an estimated percentage of ventricular pacing ≥50%
  • Ability to provide informed consent

Exclusion criteria

  • Failure to cooperate with follow-up.
  • Persistent atrial fibrillation.
  • Patients with heart failure (LVEF) ≤35%,
  • Estimated glomerular filtration rate less than 30 ml/min.
  • Septic shock
  • advanced malignant tumor.
  • Pregnancy or prepared to get pregnant
  • Cardiac tamponade or major hemopericardium

Treatment and study plan

Primary outcomes

  1. effectiveness with LBB pacing

    Time frame: 3 years

    Assess left ventricular global strain using speckle tracking echocardiography (percentage)

  2. Incidence of adverse events in patient with LBB pacing

    Time frame: 3 years

    Malignant arrhythmia(Yes/No)

  3. Incidence of septal perforation

    Time frame: 3 years

    Detect septal perforation(Yes/No)

Secondary outcomes

  1. Major Adverse Cardiovascular Events

    Time frame: 3 years

    • All-cause mortality (Yes or No) cardiovascular deaths (Yes or No) rehospitalisation with heart failure (Yes or No) Lead dislocation (Yes or No) Lead infection. (Yes or No)

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Nov 5, 2024
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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