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CSP Versus BiVP for Heart Failure Patients With RVP Upgraded to Cardiac Resynchronization Therapy

ConditionsConduction System PacingBiventricular PacingCardiac Resynchronization TherapyRight Ventricular PacingHeart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe First Affiliated Hospital with Nanjing Medical University

About this trial

The present study is a prospective, multicenter, non-inferiority, randomized controlled trail. It aims to investigate whether the efficacy of conduction system pacing (CSP) is non-inferior to biventricular pacing (BiVP) in patients with heart failure and right ventricular pacing (RVP) requiring upgrading to cardiac resynchronization therapy (CRT).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with symptomatic heart failure (LVEF <50%) after right ventricular pacing for at least 3 months;

NYHA class II-IV;

NT-proBNP >125pg/mL in patients with sinus rhythm, NT-proBNP >250pg/mL in patients with atrial fibrillation;

Right ventricular pacing percentage >40%;

Disqualifiers

History of acute myocardial infarction within 3 months before enrollment;

Frequent premature ventricular contraction (>15%) or malignant ventricular arrhythmia which is difficult to control;

History of valvular heart disease intervention within 3 months before enrollment;

After mechanical tricuspid valve replacement;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Conduction system pacing

    Device

    Firstly, we will attempt LBBP if the patient is allocated to the experimental group. If we can not achieve LBBP successfully, then we will turn to attempt HBP.

  • Biventricular pacing

    Device

    Implantation of RA lead, RV lead and LV lead are attempted using the standard-of-care technique.

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: CSP groupExperimental treatment 1 intervention
Group B: BiVP groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

ΔLVEF

Change in LVEF between baseline and six months after device implantation

Time frame
Baseline; 6-month follow-up

Secondary outcomes

1

ΔLVEDD

Change in LVEDD between baseline and follow-up

Time frame
Baseline; 3-month follow-up; 6-month follow-up
2

ΔLVEDV

Change in LVEDV between baseline and follow-up

Time frame
Baseline; 3-month follow-up; 6-month follow-up
3

ΔLVESV

Change in LVESV between baseline and follow-up

Time frame
Baseline; 3-month follow-up; 6-month follow-up
4

Paced QRS duration

Paced QRS duration is evaluated before discharge and follow-up

Time frame
1 day before discharge; 1-month follow-up; 3-month follow-up; 6-month follow-up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital with Nanjing Medical University

Lead sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Collaborator

The First Affiliated Hospital of Soochow University

Collaborator

The Affiliated Hospital of Xuzhou Medical University

Collaborator

The Third Affiliated Hospital of Soochow University

Collaborator

Rugao People's Hospital

Collaborator

Nanfang Hospital, Southern Medical University

Collaborator

First Affiliated Hospital, Sun Yat-Sen University

Collaborator

Third Affiliated Hospital, Sun Yat-Sen University

Collaborator

Shantou Central Hospital

Collaborator

Meizhou People's Hospital

Collaborator

Changzhou Second People's Hospital affiliated with Nanjing Medical University

Collaborator

Zhangjiagang First People's Hospital

Collaborator

Huizhou Third People's Hospital, Guangzhou Medical University

Collaborator

Source ClinicalTrials.gov
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