Conduction System Pacing vs Biventricular Pacing in Systolic Dysfunction and Wide QRS: Mortality, Heart Failure Hospitalization or Cardiac Transplant

Launched by HOSPITAL CLINIC OF BARCELONA · Oct 26, 2023

Keywords

ClinConnect Summary

The CONSYST-CRT II trial is studying two different types of heart pacing to see which one is better for patients with heart failure and a specific heart rhythm problem called wide QRS. The goal is to find out which method can help reduce the chances of death, the need for heart transplants, or hospitalization due to heart failure over a 12-month period. Patients who have certain heart conditions, such as a weakened heart muscle (with a specific measurement of how well the heart pumps called left ventricular ejection fraction) and specific heart rhythm issues, might be eligible to join the study.

To participate, you need to be at least 18 years old and able to give consent. The study is looking for individuals with certain heart block patterns and dysfunction who haven’t recently had major heart issues like a heart attack. If you join, you will receive one of the two types of pacing therapy and will be monitored to see how well it works for your condition over the year. This trial is currently recruiting participants of all genders, and it’s important to note that those who are pregnant or currently involved in another clinical trial with treatment cannot participate.

Gender

ALL

Eligibility criteria

• 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.