Conduction System Pacing Versus Biventricular Resynchronization in Patients With Chronic Heart Failure
NCT ID: NCT05572736
Last Updated: 2025-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
179 participants
INTERVENTIONAL
2022-11-07
2025-01-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Conduction system pacing
Patients will be randomized 1:1 to either conduction system pacing or biventricular pacing.
Conduction system pacing
Pacing from the His-Purkinje system (His-bundle pacing, left bundle branch area pacing, or deep septal pacing).
Biventricular pacing
Patients will be randomized 1:1 to either conduction system pacing or biventricular pacing.
Biventricular pacing
Pacing from the coronary sinus and right ventricular leads.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Ministry of Health, Brazil
OTHER_GOV
Hospital Moinhos de Vento
OTHER
Responsible Party
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Principal Investigators
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Carisi Polanczyk, MD PhD
Role: STUDY_CHAIR
Hospital Moinhos de Vento
Andre d'Avila, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Harvard Medical School (HMS and HSDM)
Alexander Dal Forno, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital SOS Cardio
Leandro Zimerman, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Moinhos de Vento
Luis E Rohde, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Moinhos de Vento
Andre Zimerman, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Moinhos de Vento
Caique Ternes, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Moinhos de Vento
Fernanda D Alves, PhD
Role: STUDY_DIRECTOR
Hospital Moinhos de Vento
Locations
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Fundação Hospital do Coração Francisca Mendes
Manaus, Amazonas, Brazil
Hospital Universitário Cassiano Antônio de Moraes
Vitória, Espírito Santo, Brazil
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
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
Countries
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References
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Zimerman A, Dal Forno A, Rohde LE, Ternes CM, Alves FD, Decker SR, Silveira AD, Damiani LP, Martinelli Filho M, Costa R, Fagundes AA, Barbosa RM, Gadelha EB, Lima CE, Silva MA, Maldonado JA, de Oliveira JC, Mallmann F, Baggio JM Jr, Duarte CE, Zimerman LI, D'Avila A, Polanczyk CA. Conduction system pacing vs biventricular resynchronization in heart failure with reduced ejection fraction and left bundle branch block: Rationale and design of the PhysioSync-HF Trial. Am Heart J. 2025 Dec;290:38-45. doi: 10.1016/j.ahj.2025.06.002. Epub 2025 Jun 3.
Other Identifiers
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NUP: 25000.123471/2021-59
Identifier Type: -
Identifier Source: org_study_id
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