NCT03071978

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 7, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

April 13, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2019

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2019

Completed
Last Updated

February 7, 2020

Status Verified

February 1, 2020

Enrollment Period

1.7 years

First QC Date

January 23, 2017

Last Update Submit

February 5, 2020

Conditions

Heart Failure

Keywords

Heart FailureLV-fusion pacingCardiac Resynchronization Therapy

Outcome Measures

Primary Outcomes (1)

  • Left Ventricular Ejection Fraction (LVEF)

    Change of Left Ventricular Ejection Fraction (LVEF) from Baseline to 6-month follow-up

    6-month follow up after CRT implantation

Secondary Outcomes (4)

  • New York Heart Association (NYHA) class

    6-month follow up after CRT implantation

  • 6-minute walking distance (6MWD)

    6-month follow up after CRT implantation

  • ECG QRS duration

    6-month follow up after CRT implantation

  • echocardiographic assessments (including LVESV, LVEDV, LVESD, LVEDD)

    6-month follow up after CRT implantation

Study Arms (2)

LV-fusion pacing

EXPERIMENTAL

Left Ventricular pacing (without Right Ventricular pacing)

Device: CRT with LV-only pacing / bi-ventricular pacing

BV pacing

ACTIVE COMPARATOR

Bi-Ventricular pacing

Device: CRT with LV-only pacing / bi-ventricular pacing

Interventions

CRT with LV-only pacing / bi-ventricular pacingDEVICE

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 pacingLV-fusion pacing

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Fuwai Hospital

Beijing, Beijing Municipality, 010, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, 025, China

Location

Zhongshan Hospital

Shanghai, Shanghai Municipality, 021, China

Location

First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 0991, China

Location

Greentown Hospital

Hangzhou, Zhejiang, 0571, China

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Yan-gang Su, M.D.

    ZhongShan Hospital, Shanghai

    PRINCIPAL INVESTIGATOR

  • Shu Zhang, M.D.

    Fuwai Hospital, Beijing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2017

First Posted

March 7, 2017

Study Start

April 13, 2017

Primary Completion

January 8, 2019

Study Completion

January 29, 2019

Last Updated

February 7, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(5)