Conduction System Pacing Versus Biventricular Resynchronization in Patients With Chronic Heart Failure (PhysioSync-HF)

Conduction System Pacing Versus Biventricular Resynchronization in Patients With Chronic Heart Failure (PhysioSync-HF)

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 Overview

• Status: Completed
• Conditions: Heart Failure; Left Bundle-Branch Block; Cardiac Resynchronization; Conduction System Pacing
• Intervention / Treatment: Device: Conduction system pacing; Device: Biventricular pacing

• Study Type: Interventional
• Enrollment (Actual): 179
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio De Janeiro, Brazil, 22240-006
    • Instituto Nacional de Cardiologia
  • São Paulo, Brazil, 01323-020
    • Hospital Alemao Oswaldo Cruz
  • São Paulo, Brazil, 01323-001
    • Beneficência Portuguesa
  • Amazonas
    • Manaus, Amazonas, Brazil, 69097720
      • Fundação Hospital do Coração Francisca Mendes
  • Bahia
    • Salvador, Bahia, Brazil, 40301-155
      • Hospital Ana Nery
  • Espírito Santo
    • Vitória, Espírito Santo, Brazil, 29041-295
      • Hospital Universitario Cassiano Antonio de Moraes
  • Mato Grosso
    • Cuiabá, Mato Grosso, Brazil, 78020-840
      • Hospital Geral Universitário de Cuiabá
  • Pernambuco
    • Recife, Pernambuco, Brazil, 50070-902
      • Instituto de Medicina Integral Professor Fernando Figueira
  • Piauí
    • Teresina, Piauí, Brazil, 64049-550
      • Hospital Universitário da Universidade Federal do Piauí
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
      • Hospital de Clinicas de Porto Alegre
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-000
      • Hospital Moinhos de Vento
    • Porto Alegre, Rio Grande Do Sul, Brazil, 900880-481
      • Hospital Mae de Deus
  • Santa Catarina
    • Florianópolis, Santa Catarina, Brazil, 88030-000
      • SOS Cardio
    • São José, Santa Catarina, Brazil, 88103-901
      • Instituto de Cardiologia de Santa Catarina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Conduction system pacing; Patients will be randomized 1:1 to either conduction system pacing or biventricular pacing.	Device: Conduction system pacing; Pacing from the His-Purkinje system (His-bundle pacing, left bundle branch area pacing, or deep septal pacing).
Active Comparator: Biventricular pacing; Patients will be randomized 1:1 to either conduction system pacing or biventricular pacing.	Device: Biventricular pacing; Pacing from the coronary sinus and right ventricular leads.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in left ventricular ejection fraction		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.	12 months
Change in NYHA Classification	New York Heart Association Functional Class	12 months
Change in 6-minute walk test		12 months
Change in natriuretic peptide values	BNP and NT-proBNP	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
Key secondary outcome: Cost analysis (dominance) (superiority)	Mean total direct medical cost per patient at 12 months.	12 months
Left ventricular end-diastolic volume		12 months
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

Other Outcome Measures

Outcome Measure	Time Frame
Change in peak oxygen consumption (VO2)	12 months

Collaborators and Investigators

• Sponsor: Hospital Moinhos de Vento
• Collaborators: Ministry of Health, Brazil
• Investigators: 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 d'Avila, MD PhD, Harvard Medical School (HMS and HSDM); Study Director: Fernanda D Alves, PhD, Hospital Moinhos de Vento; Study Chair: Carisi Polanczyk, 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

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2022
• Primary Completion (Actual): January 10, 2025
• Study Completion (Actual): January 10, 2025

Study Registration Dates

• First Submitted: September 2, 2022
• First Submitted That Met QC Criteria: October 5, 2022
• First Posted (Actual): October 10, 2022

Study Record Updates

• Last Update Posted (Actual): June 8, 2025
• Last Update Submitted That Met QC Criteria: June 6, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Heart Block; Heart Failure; Bundle-Branch Block
• Other Study ID Numbers: NUP: 25000.123471/2021-59

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes