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

Not Applicable

Active, not recruiting

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

Interventions: Device: Biventricular pacing
Device: Conduction system pacing

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Biventricular pacing	Biventricular pacing	Patients will be randomized 1:1 to either conduction system pacing or biventricular pacing.
Conduction system pacing	Conduction system pacing	Patients will be randomized 1:1 to either conduction system pacing or biventricular pacing.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Key secondary outcome: Cost analysis (dominance) (superiority)	12 months	Mean total direct medical cost per patient at 12 months.
Change in QRS complex	Duration of the QRS complex, defined as the widest paced QRS complex rated at 12-lead ECG, measured immediately after the index procedure
Change in left ventricular ejection fraction	12 months
Left ventricular end-diastolic volume	12 months
Change in natriuretic peptide values	12 months	BNP and NT-proBNP
Change in 6-minute walk test	12 months
Change in NYHA Classification	12 months	New York Heart Association Functional Class
Change in Kansas City Cardiomyopathy Questionnaire Overall Summary Score	12 months	The Kansas City Cardiomyopathy Questionnaire Overall Summary Score ranges from 0-100, where a lower score indicates a worse outcome.
EuroQol Group 5-Dimensions questionnaire (EQ-5D)	12 months
Hierarchical endpoint of death, hospitalization for heart failure, urgent heart failure visit, and change in KCCQ Clinical Summary Score	12 months

Locations (14): Fundação Hospital do Coração Francisca Mendes
🇧🇷
Manaus, Amazonas, Brazil
Instituto de Medicina Integral Professor Fernando Figueira
🇧🇷
Recife, Pernambuco, Brazil
Hospital Universitário da Universidade Federal do Piauí
🇧🇷
Teresina, Piauí, Brazil
Hospital Mãe de Deus
🇧🇷
Porto Alegre, Rio Grande Do Sul, Brazil
Hospital de Clínicas de Porto Alegre
🇧🇷
Porto Alegre, Rio Grande Do Sul, Brazil
SOS Cardio
🇧🇷
Florianópolis, Santa Catarina, Brazil
Instituto de Cardiologia de Santa Catarina
🇧🇷
São José, Santa Catarina, Brazil
Instituto Nacional de Cardiologia
🇧🇷
Rio De Janeiro, Brazil
Beneficência Portuguesa
🇧🇷
São Paulo, Brazil
Hospital Alemão Oswaldo Cruz
🇧🇷
São Paulo, Brazil
Hospital Ana Nery
🇧🇷
Salvador, Bahia, Brazil
Hospital Moinhos de Vento
🇧🇷
Porto Alegre, Rio Grande Do Sul, Brazil
Hospital Universitário Cassiano Antônio de Moraes
🇧🇷
Vitória, Espírito Santo, Brazil
Hospital Geral Universitário de Cuiabá
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Cuiabá, Mato Grosso, Brazil