Brief 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

Intervention / Treatment

• Device: Conduction system pacing
• Device: Biventricular pacing

Primary Outcome Measures

• Primary Outcome Measure (12 months)
  Heart failure-related net composite outcome, a hierarchical composite of all-cause death, any hospitalization for heart failure, any urgent heart failure visit, and left ventricular ejection fraction change at 12 months. The category of the composite outcome for each patient will be determined by assessing the following criteria sequentially, stopping when the event is present: All-cause death: death during follow-up. Hospitalization for heart failure: any hospitalization for heart failure during follow-up. Urgent heart failure visit: any urgent heart failure visit during follow-up. Left ventricular ejection fraction change: the difference between baseline and follow-up, categorized by every 5-point change. The distribution of outcome categories will be compared by ordinal distribution analysis. Non-inferiority margin: odds ratio \<1.2.

Countries

Brazil

Locations and Investigators

• Fundação Hospital do Coração Francisca Mendes, Manaus, Brazil
• Hospital Ana Nery, Salvador, Brazil
• Hospital Universitário Cassiano Antônio de Moraes, Vitória, Brazil
• Hospital Geral Universitário de Cuiabá, Cuiabá, Brazil
• Instituto de Medicina Integral Professor Fernando Figueira, Recife, Brazil
• Hospital Universitário da Universidade Federal do Piauí, Teresina, Brazil
• Hospital Moinhos de Vento, Porto Alegre, Brazil
• Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil
• Hospital Mãe de Deus, Porto Alegre, Brazil
• SOS Cardio, Florianópolis, Brazil
• Instituto de Cardiologia de Santa Catarina, São José, Brazil
• Instituto Nacional de Cardiologia, Rio De Janeiro, Brazil
• Beneficência Portuguesa, São Paulo, Brazil
• Hospital Alemão Oswaldo Cruz, São Paulo, Brazil

Study Officials

• Carisi Polanczyk, MD PhD (Study Chair) — Hospital Moinhos de Vento
• Andre d'Avila, MD PhD (Principal Investigator) — Harvard Medical School (HMS and HSDM)
• Alexander Dal Forno, MD (Principal Investigator) — Hospital SOS Cardio
• Leandro Zimerman, MD PhD (Principal Investigator) — Hospital Moinhos de Vento
• Luis E Rohde, MD PhD (Principal Investigator) — Hospital Moinhos de Vento
• Andre Zimerman, MD PhD (Principal Investigator) — Hospital Moinhos de Vento
• Caique Ternes, MD (Principal Investigator) — Hospital Moinhos de Vento
• Fernanda D Alves, PhD (Study Director) — Hospital Moinhos de Vento