A Randomized Controlled Trial of LOT-CRT Versus conventionaL BiVP in Heart Failure Patients With NICD

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe First Affiliated Hospital with Nanjing Medical University

About this trial

BATTLE study has been designed as a prospective, multi-center, randomized, controlled trial. This study will enroll 83 patients with chronic heart failure accompanied by intraventricular block (NICD) over an estimated recruitment period of 3 years. An LOT-CRT group will be compared with a group of conventional BiVP in the follow-up of at least 6 months. The study aimed to compare the curative effect of LOT-CRT in preserving LV systolic function with traditional BiVP in chronic heart failure patients with NICD.

Eligibility criteria

Qualifiers

Ischemic or non ischemic cardiomyopathy

Optimal medical therapy for at lest 3 months

NYHA class II-IV

LVEF≤35% as assessed by echocardiography

Disqualifiers

Valvular heart disease that requires or has undergone surgical intervention

After mechanical tricuspid valve replacement

Persistent or permanent atrial fibrillation or atrial flutter

Second or third degree atrioventricular block

Trial design

Treatments tested in this trial

  • LOT-CRT group
  • BiVP group

Treatment groups

86 Participants
are divided into 2 treatment groups

Sponsors and collaborators

The First Affiliated Hospital with Nanjing Medical University

Lead sponsor

Shanghai Zhongshan Hospital

Collaborator

Sir Run Run Shaw Hospital

Collaborator

Fu Wai Hospital, Beijing, China

Collaborator

West China Hospital

Collaborator

The First Affiliated Hospital of Dalian Medical University

Collaborator

The First People's Hospital of Yunnan

Collaborator

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Collaborator

Guangdong Provincial People's Hospital

Collaborator

Shanghai Tong Ren Hospital

Collaborator

Fujian Provincial Hospital

Collaborator

Fujian Medical University Union Hospital

Collaborator