Application of Right Atrial Left Ventricular Fusion Pacing in Patients With CRT Indications
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      This study is designed to assess the clinical outcomes of Left-Ventricular (LV) fusion pacing
      compared to Bi-Ventricular (BV) pacing, also known as Cardiac Resynchronization Therapy
      (CRT), in Chinese Heart Failure (HF) population. Specifically, the study will assess the
      changes of cardiac function of each group through 3-month follow up/ 6-month follow up
      compared with original outcomes before aCRT (adaptive Cardiac Resynchronization Therapy)
      implantation. Secondly, the study will assess whether parameters of aCRT that were tested in
      Western population are relevant to parameters of Chinese HF patients.
    

Detailed description: 
      Traditional dual-chamber pacemakers usually utilize pacing at right atrium (RA) and right
      ventricle (RV). But many clinical studies have proved that permanent RV pacing could cause
      ventricular desynchronization in electrical activation and mechanical movement, also may lead
      to atrial fibrillation and cardiac failure in the long term. Cardiac Resynchronization
      Therapy (CRT) can overcome the ventricular desynchrony caused by permanent RV pacing, through
      pacing both left and right ventricles. But the cost of CRT device is usually expensive in
      emerging markets like in China. Recently, a few clinical studies have demonstrated that
      LV-fusion pacing (without RV pacing) using adaptive CRT feature provides better clinical
      outcomes than RV pacing, and also equivalent clinical improvements compared to conventional
      CRT pacing. However, it is unknown whether similar results can be duplicated in Chinese
      population as the clinical profile of Chinese CRT populations is different from that of
      Western CRT population.

      This study is designed to assess the clinical outcomes of Left-Ventricular (LV) fusion pacing
      compared to Bi-Ventricular (BV) pacing in Chinese Heart Failure population. Specifically, the
      study will assess the changes of cardiac function of each group through 3-month follow up/
      6-month follow up compared with original outcomes before aCRT implantation. Secondly, the
      study will assess whether parameters of aCRT that were tested in Western population are
      relevant to parameters of Chinese HF patients.

      CRT-indicated heart failure patients who meet the Inclusion & Exclusion criteria will be
      enrolled voluntarily in this study. No intervention will be assigned to enrolled patients.
      CRT therapy will be assigned according to the Guideline (ESC Guidelines for the diagnosis and
      treatment of acute and chronic heart failure 2012). Left-Ventricular (LV) fusion pacing or
      Bi-Ventricular (BV) pacing mode, both included in CRT therapy, will be applied upon
      physicians' judgment based on the Guideline and patients' specific situations. Both pacing
      modes, as well as all the clinical assessments in this study, are routine cares in clinical
      practice.

      The study will enroll up to 30 subjects in each group (LV pacing group and BV pacing group)
      that meet the indication for CRT therapy, and also the Inclusion & Exclusion criteria.
      Consented subjects will receive CRT therapy and two follow-ups in the following 3 and 6
      months.
    

Intervention name(s): CRT with LV-only pacing / bi-ventricular pacing
Intervention type(s): Device
Intervention description(s): LV-fusion pacing group received cardiac resynchronization therapy with adaptive algorithm and disabled RV pacing. While BV pacing group received conventional cardiac resynchronization therapy without adaptive algorithm.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Heart Failure; LV-fusion pacing; Cardiac Resynchronization Therapy