Conduction System Pacing vs Biventricular Pacing in Systolic Dysfunction and Wide QRS: Mortality, Heart Failure Hospitalization or Cardiac Transplant
Conduction System Pacing vs Biventricular Resynchronization Therapy in Systolic Dysfunction and Wide QRS: Mortality, Heart Failure Hospitalization or Cardiac Transplant
Hospital Clinic of Barcelona
320 participants
Nov 27, 2023
INTERVENTIONAL
Conditions
Summary
Conduction system pacing vs biventricular resynchronization therapy in systolic dysfunction and wide QRS: mortality, heart failure hospitalization or cardiac transplant (CONSYST-CRT II trial). Superiority trial that aims to study the composite endpoint consisting of all-cause mortality, cardiac transplant or heart failure hospitalization at 12-month follow-up.
Eligibility
Inclusion Criteria6
- Patient must indicate acceptance to participate in the study by signing an informed consent document.
- 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%.
- Resynchronization therapy indication for ventricular dysfunction (LVEF \<40%) and indication of cardiac pacing for AV block.
- LVEF \<=35% in NYHA class III or IV, atrial fibrillation and intrinsic QRS \>=130 ms, provided a strategy to ensure biventricular capture is in place.
Exclusion Criteria3
- Myocardial infarction, unstable angina or cardiac revascularization during the previous 3 months.
- Pregnancy.
- Participating currently in a clinical investigation that includes an active treatment.
Interventions
Conduction system pacing implant as a Resynchronization therapy.
Biventricular pacing implant
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06105580