Conduction System Pacing, Resynchronization Therapy
Conditions
Keywords
Resynchronization Therapy, Biventricular pacing, Conduction system pacing
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)
Interventions
DEVICEConduction system pacing
Lead placed in the His-Purkinje system in order to achieve QRS shortening.
DEVICEBiventricular pacing
Lead is placed in a tributary of the coronary sinus.
Sponsors
Hospital Clinic of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
The first 70 patients have been recruited in the context of the LEVELAT study (ClinicalTrials.gov Identifier: NCT04054895)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite end-point: all-cause mortality, cardiac transplant, heart failure hospitalization, and left ventricular ejection fraction (LVEF) improvement <5 points. | 12 months | Non inferiority margin 10%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in left ventricular end-systolic volume. | 6 months; 12 months | Non inferiority margin 3% |
| Echocardiographic response (>=15% decrease in left ventricular end-systolic volume). | 6 months; 12 months | Non inferiority margin 10% |
| Hospitalization due to heart failure, mortality or cardiac transplant (combined endpoint) | 6 months; 12 months | Non inferiority margin 10% |
| Change in left ventricular ejection fraction. | 6 months; 12 months | Non inferiority margin 2.5% |
| Correction of septal flash | 15 days; 6 months; 12 months | Non inferiority margin 0.5mm |
| Change in NYHA functional class | 6 months; 12 months | NYHA functional class I, II, III, IV. |
| QRS shortening | Post-implantation (Electrophysiology Lab) | Non inferiority margin 12ms |
Countries
Spain
Outcome results
None listed