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| Name | Class |
|---|---|
| Ministry of Health, Brazil | OTHER_GOV |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conduction system pacing | Experimental | Patients will be randomized 1:1 to either conduction system pacing or biventricular pacing. |
|
| Biventricular pacing | Active Comparator | Patients will be randomized 1:1 to either conduction system pacing or biventricular pacing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conduction system pacing | Device | Pacing from the His-Purkinje system (His-bundle pacing, left bundle branch area pacing, or deep septal pacing). |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Key secondary outcome: Cost analysis (dominance) (superiority) | Mean total direct medical cost per patient at 12 months. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in peak oxygen consumption (VO2) | 12 months |
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundação Hospital do Coração Francisca Mendes | Manaus | Amazonas | 69097720 | Brazil | ||
| Hospital Universitário Cassiano Antônio de Moraes |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41811324 | Derived | Zimerman A, Dal Forno A, Rohde LE, Ternes CM, Alves FD, 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 Junior JM, Duarte CE, de Souza LA, Santos JS, Silveira AD, Decker SRR, Zimerman LI, Polanczyk CA, d'Avila A. Conduction System vs Biventricular Pacing in Heart Failure: The PhysioSync-HF Randomized Clinical Trial. JAMA Cardiol. 2026 Apr 1;11(4):360-368. doi: 10.1001/jamacardio.2026.0101. | |
| 41779515 |
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| Biventricular pacing | Device | Pacing from the coronary sinus and right ventricular leads. |
|
| Change in left ventricular ejection fraction | 12 months |
| Left ventricular end-diastolic volume | 12 months |
| Change in natriuretic peptide values | BNP and NT-proBNP | 12 months |
| Change in 6-minute walk test | 12 months |
| Change in NYHA Classification | New York Heart Association Functional Class | 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 |
| 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 |
| Vitória |
| Espírito Santo |
| 29041-295 |
| Brazil |
| Hospital Ana Nery | Salvador | Estado de Bahia | 40301-155 | Brazil |
| Hospital Geral Universitário de Cuiabá | Cuiabá | Mato Grosso | 78020-840 | Brazil |
| Instituto de Medicina Integral Professor Fernando Figueira | Recife | Pernambuco | 50070-902 | Brazil |
| Hospital Universitário da Universidade Federal do Piauí | Teresina | Piauí | 64049-550 | Brazil |
| Hospital Moinhos de Vento | Porto Alegre | Rio Grande do Sul | 90035-000 | Brazil |
| Hospital de Clínicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| Hospital Mãe de Deus | Porto Alegre | Rio Grande do Sul | 900880-481 | Brazil |
| SOS Cardio | Florianópolis | Santa Catarina | 88030-000 | Brazil |
| Instituto de Cardiologia de Santa Catarina | São José | Santa Catarina | 88103-901 | Brazil |
| Instituto Nacional de Cardiologia | Rio de Janeiro | 22240-006 | Brazil |
| Beneficência Portuguesa | São Paulo | 01323-001 | Brazil |
| Hospital Alemão Oswaldo Cruz | São Paulo | 01323-020 | Brazil |
| Derived |
| Decker SRR, Etges APBDS, Zimerman A, Alves FD, Ternes CM, Santos JS, Zimerman L, Rohde LE, Forno AD, d'Avila A, Kazi DS, Bertoldi EG, Polanczyk CA. Conduction System Pacing vs Biventricular Pacing in Chronic Heart Failure: Protocol for the Economic Analysis of the PhysioSync-HF Trial. Arq Bras Cardiol. 2025 Dec;122(12):e20250254. doi: 10.36660/abc.20250254. English, Portuguese. |
| 40473010 | Derived | 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. |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D002037 | Bundle-Branch Block |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006327 | Heart Block |
| D001145 | Arrhythmias, Cardiac |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D058406 | Cardiac Resynchronization Therapy |
| ID | Term |
|---|---|
| D002304 | Cardiac Pacing, Artificial |
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
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