Status:
RECRUITING
Conduction System Pacing vs Biventricular Pacing in Systolic Dysfunction and Wide QRS: Mortality, Heart Failure Hospitalization or Cardiac Transplant
Lead Sponsor:
Hospital Clinic of Barcelona
Collaborating Sponsors:
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Conditions:
Cardiac Resynchronization Therapy
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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). Superi...
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 320 patien...
Eligibility Criteria
Inclusion
- 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
- Myocardial infarction, unstable angina or cardiac revascularization during the previous 3 months.
- Pregnancy.
- Participating currently in a clinical investigation that includes an active treatment.
Key Trial Info
Start Date :
November 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT06105580
Start Date
November 27 2023
End Date
November 1 2027
Last Update
March 17 2025
Active Locations (1)
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1
Hospital Clínic de Barcelona
Barcelona, Spain