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Completed

NCT Number: NCT05572736

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

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.

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Key information

Conditions

Heart Failure Arrhythmias, Cardiac Bundle-Branch Block Cardiac Conduction System Disease Cardiac Resynchronization Cardiovascular Diseases Conduction System Pacing Heart Block Heart Diseases Left Bundle-Branch Block Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fundação Hospital do Coração Francisca Mendes, Manaus, Amazonas, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

conduction system pacing

Device

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

Biventricular Pacing

Device

Pacing from the coronary sinus and right ventricular leads.

Primary outcomes

  1. Primary Outcome Measure

    Time frame: 12 months

    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.

Secondary outcomes

  1. Key secondary outcome: Cost analysis (dominance) (superiority)

    Time frame: 12 months

    Mean total direct medical cost per patient at 12 months.

  2. 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

  3. Change in left ventricular ejection fraction

    Time frame: 12 months

  4. Left ventricular end-diastolic volume

    Time frame: 12 months

  5. Change in natriuretic peptide values

    Time frame: 12 months

    BNP and NT-proBNP

  6. Change in 6-minute walk test

    Time frame: 12 months

  7. Change in NYHA Classification

    Time frame: 12 months

    New York Heart Association Functional Class

  8. Change in Kansas City Cardiomyopathy Questionnaire Overall Summary Score

    Time frame: 12 months

    The Kansas City Cardiomyopathy Questionnaire Overall Summary Score ranges from 0-100, where a lower score indicates a worse outcome.

  9. EuroQol Group 5-Dimensions questionnaire (EQ-5D)

    Time frame: 12 months

  10. Hierarchical endpoint of death, hospitalization for heart failure, urgent heart failure visit, and change in KCCQ Clinical Summary Score

    Time frame: 12 months

Other outcomes

  1. Change in peak oxygen consumption (VO2)

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Hospital Moinhos de Vento

Other

Collaborators

  • Ministry of Health, Brazil

Registry information

Official study title

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

Acronym: PhysioSync-HF

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 10, 2022
Registry last updated
Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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