Clinical trial NCT03071978: Application of Right Atrial Left Ventricular Fusion Pacing in Patients With CRT Indications
Official title: Application of Right Atrial Left Ventricular Fusion Pacing in Patients With CRT (Cardiac Resynchronization Therapy) Indications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Heart Failure
LV-fusion pacing
Cardiac Resynchronization Therapy
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2017-03-07
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Left Ventricular Ejection Fraction (LVEF)
timeFrame: 6-month follow up after CRT implantation
Secondary outcomes:
measure: New York Heart Association (NYHA) class
timeFrame: 6-month follow up after CRT implantation
measure: 6-minute walking distance (6MWD)
timeFrame: 6-month follow up after CRT implantation
measure: ECG QRS duration
timeFrame: 6-month follow up after CRT implantation
measure: echocardiographic assessments (including LVESV, LVEDV, LVESD, LVEDD)
timeFrame: 6-month follow up after CRT implantation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital
state: Beijing
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
city: Urumqi
country: China
facility: First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Hangzhou
country: China
facility: Greentown Hospital
state: Zhejiang
Study officials:
affiliation: ZhongShan Hospital, Shanghai
name: Yan-gang Su, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Fuwai Hospital, Beijing
name: Shu Zhang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: