Conduction System Pacing Versus Biventricular Resynchronization in Patients With Chronic Heart Failure (PhysioSync-HF)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Hospital Moinhos de Vento
- Enrollment
- 179
- Locations
- 14
- Primary Endpoint
- Primary Outcome Measure
- Status
- Completed
- Last Updated
- 10 months ago
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
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)