Conduction System Pacing Versus Biventricular Resynchronization in Patients With Chronic Heart Failure

Summary

The purpose of this study is to evaluate the efficacy and safety of conduction system pacing versus biventricular pacing in patients with chronic heart failure with reduced ejection fraction and left bundle branch block.

Conditions

• Heart Failure
• Left Bundle-Branch Block
• Cardiac Resynchronization
• Conduction System Pacing

Interventions

DEVICE

Conduction system pacing

Pacing from the His-Purkinje system (His-bundle pacing, left bundle branch area pacing, or deep septal pacing).

DEVICE

Biventricular pacing

Pacing from the coronary sinus and right ventricular leads.

Sponsors & Collaborators

• Ministry of Health, Brazil

  collaborator OTHER_GOV

• Hospital Moinhos de Vento

  lead OTHER

Principal Investigators

• Carisi Polanczyk, MD PhD · Hospital Moinhos de Vento

• Andre d'Avila, MD PhD · Harvard Medical School (HMS and HSDM)

• Alexander Dal Forno, MD · Hospital SOS Cardio

• Leandro Zimerman, MD PhD · Hospital Moinhos de Vento

• Luis E Rohde, MD PhD · Hospital Moinhos de Vento

• Andre Zimerman, MD PhD · Hospital Moinhos de Vento

• Caique Ternes, MD · Hospital Moinhos de Vento

• Fernanda D Alves, PhD · Hospital Moinhos de Vento

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-11-07

Primary Completion

2025-01-10

Completion

2025-01-10

FDA Device

Yes

Countries

• Brazil

Study Locations