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

Heart Failure Clinical Trial

— PhysioSync-HF  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05572736
• Other study ID #: NUP: 25000.123471/2021-59
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 7, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: Hospital Moinhos de Vento
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effect of conduction system pacing versus biventricular pacing on death, worsening heart failure, and left ventricular ejection fraction in patients with chronic heart failure with reduced ejection fraction and left bundle branch block.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 179
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bundle-Branch Block
• Cardiac Resynchronization
• Conduction System Pacing
• Heart Failure
• Left Bundle-Branch Block

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Brazil	Hospital Geral Universitário de Cuiabá	Cuiabá	Mato Grosso
Brazil	SOS Cardio	Florianópolis	Santa Catarina
Brazil	Fundação Hospital do Coração Francisca Mendes	Manaus	Amazonas
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	Hospital Moinhos de Vento	Porto Alegre	Rio Grande Do Sul
Brazil	Instituto de Medicina Integral Professor Fernando Figueira	Recife	Pernambuco
Brazil	Instituto Nacional de Cardiologia	Rio De Janeiro
Brazil	Hospital Ana Nery	Salvador	Bahia
Brazil	Instituto de Cardiologia de Santa Catarina	São José	Santa Catarina
Brazil	Beneficência Portuguesa	São Paulo
Brazil	Hospital Alemão Oswaldo Cruz	São Paulo
Brazil	Hospital Universitário da Universidade Federal do Piauí	Teresina	Piauí
Brazil	Hospital Universitário Cassiano Antônio de Moraes	Vitória	Espírito Santo

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Moinhos de Vento	Ministry of Health, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Change in NYHA Classification	New York Heart Association Functional Class	12 months
Other	Change in 6-minute walk test		12 months
Other	Change in ergospirometry test		12 months
Other	Change in natriuretic peptide values	BNP and NT-proBNP	12 months
Other	Change in left ventricular ejection fraction		12 months
Other	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
Other	Procedure time		The duration of the procedure (in minutes) measured immediately after the index procedure
Other	Time to composite endpoint of cardiovascular death or hospitalization for heart failure		12 months
Other	Primary Outcome Measure in the Per-Protocol Population	Non-inferiority of clinical benefit, 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 in the per-protocol population.; The category of clinical benefit of 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 clinical benefit categories will be compared by ordinal distribution analysis. Non-inferiority margin: odds ratio <1.2.	12 months
Other	Left ventricular activation time		12 months
Primary	Primary Outcome Measure	Non-inferiority of clinical benefit, 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 clinical benefit of 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 clinical benefit categories will be compared by ordinal distribution analysis. Non-inferiority margin: odds ratio <1.2.	12 months
Secondary	Key secondary outcome: Cost-effectiveness analysis (dominance) (superiority)	Time-Driven Activity-Based Costing analysis to assess cost-effectiveness of the intervention.	12 months
Secondary	Time to composite endpoint of all-cause death, hospitalization for heart failure, or urgent heart failure visit		12 months