Conduction System Pacing vs Biventricular Pacing in Systolic Dysfunction and Wide QRS: Mortality, Heart Failure Hospitalization or Cardiac Transplant
Recruiting · NCT06105580 · Interventional (participants receive a specific treatment) · Lead sponsor: Hospital Clinic of Barcelona
View the official record on ClinicalTrials.gov →Interventions studied
Biventricular pacingConduction system pacing
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 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.
Where it is running
1 location listed.
- Hospital Clínic de Barcelona - Barcelona, Spain