Conduction System Pacing Versus Biventricular Resynchronization in Patients With Chronic Heart Failure (PhysioSync-HF)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hospital Moinhos de Vento
- Enrollment
- 179
- Locations
- 14
- Primary Endpoint
- Primary Outcome Measure
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Conduction system pacing
Patients will be randomized 1:1 to either conduction system pacing or biventricular pacing.
Intervention: Conduction system pacing (Device)
Biventricular pacing
Patients will be randomized 1:1 to either conduction system pacing or biventricular pacing.
Intervention: Biventricular pacing (Device)
Outcomes
Primary Outcomes
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
- 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)
- Change in 6-minute walk test(12 months)
- Change in NYHA Classification(12 months)
- Change in Kansas City Cardiomyopathy Questionnaire Overall Summary Score(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)