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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
179
Pacing from the His-Purkinje system (His-bundle pacing, left bundle branch area pacing, or deep septal pacing).
Pacing from the coronary sinus and right ventricular leads.
Fundação Hospital do Coração Francisca Mendes
Manaus, Amazonas, Brazil
Hospital Universitário Cassiano Antônio de Moraes
Vitória, Espírito Santo, Brazil
Primary Outcome Measure
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.
Time frame: 12 months
Key secondary outcome: Cost analysis (dominance) (superiority)
Mean total direct medical cost per patient at 12 months.
Time frame: 12 months
Change in QRS complex
Time frame: 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
Time frame: 12 months
Left ventricular end-diastolic volume
Time frame: 12 months
Change in natriuretic peptide values
BNP and NT-proBNP
Time frame: 12 months
Change in 6-minute walk test
Time frame: 12 months
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Hospital Ana Nery
Salvador, Estado de Bahia, Brazil
Hospital Geral Universitário de Cuiabá
Cuiabá, Mato Grosso, Brazil
Instituto de Medicina Integral Professor Fernando Figueira
Recife, Pernambuco, Brazil
Hospital Universitário da Universidade Federal do Piauí
Teresina, Piauí, Brazil
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Mãe de Deus
Porto Alegre, Rio Grande do Sul, Brazil
SOS Cardio
Florianópolis, Santa Catarina, Brazil
...and 4 more locations
Change in NYHA Classification
New York Heart Association Functional Class
Time frame: 12 months
Change in Kansas City Cardiomyopathy Questionnaire Overall Summary Score
The Kansas City Cardiomyopathy Questionnaire Overall Summary Score ranges from 0-100, where a lower score indicates a worse outcome.
Time frame: 12 months
EuroQol Group 5-Dimensions questionnaire (EQ-5D)
Time frame: 12 months
Hierarchical endpoint of death, hospitalization for heart failure, urgent heart failure visit, and change in KCCQ Clinical Summary Score
Time frame: 12 months