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

NCT05572736 | Completed DMC FDA Device

• 1 other identifier: NUP: 25000.123471/2021-59
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 14

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

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (10)

• Key secondary outcome: Cost analysis (dominance) (superiority)

  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

Other Outcomes (1)

• Change in peak oxygen consumption (VO2)

  12 months

Study Arms (2)

Conduction system pacing

EXPERIMENTAL

Patients will be randomized 1:1 to either conduction system pacing or biventricular pacing.

Device: Conduction system pacing

Biventricular pacing

ACTIVE COMPARATOR

Patients will be randomized 1:1 to either conduction system pacing or biventricular pacing.

Device: Biventricular pacing

Interventions

Conduction system pacing DEVICE

Pacing from the His-Purkinje system (His-bundle pacing, left bundle branch area pacing, or deep septal pacing).

Conduction system pacing

Biventricular pacing DEVICE

Pacing from the coronary sinus and right ventricular leads.

Biventricular pacing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Moinhos de Vento: lead
• Ministry of Health, Brazil: collaborator

Study Sites (14)

Fundação Hospital do Coração Francisca Mendes

Manaus, Amazonas, 69097720, Brazil

Location

Hospital Universitário Cassiano Antônio de Moraes

Vitória, Espírito Santo, 29041-295, Brazil

Location

Hospital Ana Nery

Salvador, Estado de Bahia, 40301-155, Brazil

Location

Hospital Geral Universitário de Cuiabá

Cuiabá, Mato Grosso, 78020-840, Brazil

Location

Instituto de Medicina Integral Professor Fernando Figueira

Recife, Pernambuco, 50070-902, Brazil

Location

Hospital Universitário da Universidade Federal do Piauí

Teresina, Piauí, 64049-550, Brazil

Location

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, 90035-000, Brazil

Location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Hospital Mãe de Deus

Porto Alegre, Rio Grande do Sul, 900880-481, Brazil

Location

SOS Cardio

Florianópolis, Santa Catarina, 88030-000, Brazil

Location

Instituto de Cardiologia de Santa Catarina

São José, Santa Catarina, 88103-901, Brazil

Location

Instituto Nacional de Cardiologia

Rio de Janeiro, 22240-006, Brazil

Location

Beneficência Portuguesa

São Paulo, 01323-001, Brazil

Location

Hospital Alemão Oswaldo Cruz

São Paulo, 01323-020, Brazil

Location

Related Publications (1)

• 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.

  PMID: 40473010 DERIVED

MeSH Terms

Conditions

Heart Failure; Bundle-Branch Block

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Heart Block; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Pacing, Artificial; Electric Stimulation Therapy; Therapeutics

Study Officials

• Carisi Polanczyk, MD PhD

  Hospital Moinhos de Vento

  STUDY CHAIR

• Andre d'Avila, MD PhD

  Harvard Medical School (HMS and HSDM)

  PRINCIPAL INVESTIGATOR

• Alexander Dal Forno, MD

  Hospital SOS Cardio

  PRINCIPAL INVESTIGATOR

• Leandro Zimerman, MD PhD

  Hospital Moinhos de Vento

  PRINCIPAL INVESTIGATOR

• Luis E Rohde, MD PhD

  Hospital Moinhos de Vento

  PRINCIPAL INVESTIGATOR

• Andre Zimerman, MD PhD

  Hospital Moinhos de Vento

  PRINCIPAL INVESTIGATOR

• Caique Ternes, MD

  Hospital Moinhos de Vento

  PRINCIPAL INVESTIGATOR

• Fernanda D Alves, PhD

  Hospital Moinhos de Vento

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: October 10, 2022
• Study Start: November 7, 2022
• Primary Completion: January 10, 2025
• Study Completion: January 10, 2025
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (14)