Status:
COMPLETED
Conduction System Pacing vs Biventricular Resynchronization Therapy in Systolic Dysfunction and Wide QRS: CONSYST-CRT.
Lead Sponsor:
Hospital Clinic of Barcelona
Conditions:
Resynchronization Therapy
Conduction System Pacing
Eligibility:
All Genders
18+ years
Phase:
NA
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 compo...
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 patien...
Eligibility Criteria
Inclusion
- 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
- 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 :
January 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2025
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT05187611
Start Date
January 17 2022
End Date
April 1 2025
Last Update
July 10 2025
Active Locations (1)
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1
Lluís Mont
Barcelona, Spain