Heart Failure
Conditions
Keywords
Heart Failure, LV-fusion pacing, Cardiac Resynchronization Therapy
Brief 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.
Interventions
DEVICECRT with LV-only pacing / bi-ventricular pacing
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.
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18\ 80 * Life expectancy \> 1 year * Sign Informed Consent * CRT-indicated * NYHA (New York Heart Association) class II and III * PR (term in Electrocardiograph) interval \< 200 ms * ECG (Electrocardiograph) LBBB (left bundle branch block)
Exclusion criteria
* Patient with severe liver or kidney dysfunction * CRT-contraindication * CRT-upgraded * Persistent AF (atrial fibrillation) * AV block (atrioventricular block) * RBBB (right bundle branch block) * Valvular Disease * LV threshold ≥ 3.5 volt * Patient is unwilling to sign the informed consent * Patient is pregnant or has pregnancy intention in the study duration * Patient has a medical condition that would limit study participation * Patient is enrolled in a concurrent study that may affect the outcome of this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Left Ventricular Ejection Fraction (LVEF) | 6-month follow up after CRT implantation | Change of Left Ventricular Ejection Fraction (LVEF) from Baseline to 6-month follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| New York Heart Association (NYHA) class | 6-month follow up after CRT implantation | Change of New York Heart Association (NYHA) class from Baseline to 6-month follow-up |
| 6-minute walking distance (6MWD) | 6-month follow up after CRT implantation | Change of 6-minute walking distance (6MWD) from Baseline to 6-month follow-up |
| ECG QRS duration | 6-month follow up after CRT implantation | Change of ECG QRS duration from Baseline to 6-month follow-up |
| echocardiographic assessments (including LVESV, LVEDV, LVESD, LVEDD) | 6-month follow up after CRT implantation | Change of echocardiographic assessments (including LVESV, LVEDV, LVESD, LVEDD) from Baseline to 6-month follow-up |
Countries
China
Outcome results
None listed