Conduction System Pacing vs Biventricular Resynchronization Therapy in Systolic Dysfunction and Wide QRS: CONSYST-CRT Randomized Clinical Trial.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Resynchronization Therapy
- Sponsor
- Hospital Clinic of Barcelona
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- Composite end-point: all-cause mortality, cardiac transplant, heart failure hospitalization, and left ventricular ejection fraction (LVEF) improvement <5 points.
- Status
- Completed
- Last Updated
- 9 months ago
Overview
Brief Summary
Conduction system pacing vs biventricular resynchronization therapy in systolic dysfunction and wide QRS (CONSYST-CRT randomized clinical trial) is a non-inferiority trial that aims to study the composite endpoint consisting of all-cause mortality, cardiac transplant, heart failure hospitalizations, and left ventricular ejection fraction (LVEF) improvement <5 points.
Detailed Description
To date, studies have shown that conduction system pacing could get similar clinical and echocardiographic responses to those obtained with biventricular therapy. This study will randomize 130 patients to a strategy of biventricular pacing versus conduction system pacing. CONSYST-CRT study will analyze the following parameters in the 2 groups: left ventricular ejection fraction, ventricular volumes, echocardiographic response (\>=15% decrease in left ventricular end-systolic volume), NYHA functional class, heart failure hospitalization, all-cause mortality, cardiac transplant, QRS shortening, echocardiographic asynchrony (septal flash). Clinical, electrocardiographic, echocardiographic follow-up will be performed for 1 year. The first 70 patients have been recruited in the context of the LEVELAT study (ClinicalTrials.gov Identifier: NCT04054895)
Investigators
Josep Lluis Mont Girbau
Principal Investigator
Hospital Clinic of Barcelona
Eligibility Criteria
Inclusion Criteria
- •The patient must indicate their acceptance to participate in the study by signing an informed consent document.
- •The patient must be ≥ 18 years of age.
- •Left bundle branch block, QRS ≥130 and LVEF \<=35%. No indication of stimulation for AV block.
- •Non-left bundle branch block, QRS ≥150 and LVEF \<=35%.
- •Patients with indication of resynchronization therapy for ventricular dysfunction (LVEF \<40%) and indication of cardiac pacing for AV block.
- •LVEF \<=35% in NYHA class III or IV if they are in atrial fibrillation and have intrinsic QRS \>=130 ms, provided a strategy to ensure biventricular capture is in place.
Exclusion Criteria
- •Myocardial infarction, unstable angina or cardiac revascularization during the previous 3 months.
- •Pregnancy.
- •Participating currently in a clinical investigation that includes an active treatment.
Outcomes
Primary Outcomes
Composite end-point: all-cause mortality, cardiac transplant, heart failure hospitalization, and left ventricular ejection fraction (LVEF) improvement <5 points.
Time Frame: 12 months
Non inferiority margin 10%.
Secondary Outcomes
- Change in left ventricular end-systolic volume.(6 months; 12 months)
- QRS shortening(Post-implantation (Electrophysiology Lab))
- Change in left ventricular ejection fraction.(6 months; 12 months)
- Echocardiographic response (>=15% decrease in left ventricular end-systolic volume).(6 months; 12 months)
- Hospitalization due to heart failure, mortality or cardiac transplant (combined endpoint)(6 months; 12 months)
- Change in NYHA functional class(6 months; 12 months)
- Correction of septal flash(15 days; 6 months; 12 months)