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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05572736
Other study ID # NUP: 25000.123471/2021-59
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date November 7, 2022
Est. completion date December 31, 2024

Study information

Verified date December 2023
Source Hospital Moinhos de Vento
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effect of conduction system pacing versus biventricular pacing on death, worsening heart failure, and left ventricular ejection fraction in patients with chronic heart failure with reduced ejection fraction and left bundle branch block.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 179
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria: - Male or female, age =18 years - Established diagnosis of symptomatic heart failure (New York Heart Association class II-III) - Left ventricular ejection fraction =35% in prior 3 months - Left bundle branch block (QRS =130 ms) - Clinical indication for cardiac resynchronization therapy - Patients should be clinically stable - Patients should receive background standard of care for heart failure with reduced ejection fraction, with the maximum tolerated doses of ACE inhibitor or ARB or ARNI, beta-blocker, and mineralocorticoid receptor antagonist Exclusion criteria: - Life expectancy <12 months due to any disease - Dementia or advanced cerebrovascular disease - NYHA class IV - Plan to implant an implantable cardioverter defibrillator (ICD), with or without resynchronization therapy (CRT-D) - Enrollment in other clinical trials involving cardiac pacing - Pregnancy or pre-menopausal women who do not use regular contraceptive methods - Patients unable to understand and sign the consent for participation

Study Design


Intervention

Device:
Conduction system pacing
Pacing from the His-Purkinje system (His-bundle pacing, left bundle branch area pacing, or deep septal pacing).
Biventricular pacing
Pacing from the coronary sinus and right ventricular leads.

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Hospital Moinhos de Vento Ministry of Health, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Other 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. 12 months
Other Change in NYHA Classification New York Heart Association Functional Class 12 months
Other Change in 6-minute walk test 12 months
Other Change in ergospirometry test 12 months
Other Change in natriuretic peptide values BNP and NT-proBNP 12 months
Other Change in left ventricular ejection fraction 12 months
Other 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
Other Procedure time The duration of the procedure (in minutes) measured immediately after the index procedure
Other Time to composite endpoint of cardiovascular death or hospitalization for heart failure 12 months
Other Primary Outcome Measure in the Per-Protocol Population Non-inferiority of clinical benefit, 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 in the per-protocol population.
The category of clinical benefit of 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 clinical benefit categories will be compared by ordinal distribution analysis. Non-inferiority margin: odds ratio <1.2.
12 months
Other Left ventricular activation time 12 months
Primary Primary Outcome Measure Non-inferiority of clinical benefit, 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 clinical benefit of 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 clinical benefit categories will be compared by ordinal distribution analysis. Non-inferiority margin: odds ratio <1.2.
12 months
Secondary Key secondary outcome: Cost-effectiveness analysis (dominance) (superiority) Time-Driven Activity-Based Costing analysis to assess cost-effectiveness of the intervention. 12 months
Secondary Time to composite endpoint of all-cause death, hospitalization for heart failure, or urgent heart failure visit 12 months
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