Application of Right Atrial Left Ventricular Fusion Pacing in Patients With CRT Indications

NCT ID: NCT03071978

Last Updated: 2020-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-13
• Study Completion Date: 2019-01-29

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LV-fusion pacing

Left Ventricular pacing (without Right Ventricular pacing)

Group Type: EXPERIMENTAL

CRT with LV-only pacing / bi-ventricular pacing

Intervention Type: DEVICE

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.

BV pacing

Bi-Ventricular pacing

Group Type: ACTIVE_COMPARATOR

CRT with LV-only pacing / bi-ventricular pacing

Intervention Type: DEVICE

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.

Interventions

CRT 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yan-gang Su, M.D.

Role: PRINCIPAL_INVESTIGATOR

ZhongShan Hospital, Shanghai

Shu Zhang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Fuwai Hospital, Beijing

Locations

Fuwai Hospital

Beijing, Beijing Municipality, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Zhongshan Hospital

Shanghai, Shanghai Municipality, China

First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Greentown Hospital

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

LV Study

Identifier Type: -

Identifier Source: org_study_id