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Conduction System Pacing vs Biventricular Pacing in Systolic Dysfunction and Wide QRS: Mortality, Heart Failure Hospitalization or Cardiac Transplant
RECRUITINGN/ASponsored by Hospital Clinic of Barcelona
Actively Recruiting
PhaseN/A
SponsorHospital Clinic of Barcelona
Started2023-11-27
Est. completion2027-11
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06105580
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
Age: 18 Years+Healthy volunteers accepted
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.
Conditions3
Cardiac Resynchronization TherapyHeart DiseaseHeart Failure
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Actively Recruiting
PhaseN/A
SponsorHospital Clinic of Barcelona
Started2023-11-27
Est. completion2027-11
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06105580