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Clinical Trials in Spain / NCT06105580
Recruiting Not applicable

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

NCT06105580 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2023-11-27
Last updated
2026-04-03

Condition(s) studied

Cardiac Resynchronization TherapyHeart Failure

Investigational drug(s) / intervention(s)

Conduction system pacingBiventricular pacing

Conduction system pacing: Conduction system pacing implant as a Resynchronization therapy.

Biventricular pacing: Biventricular pacing implant

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hospital Clínic de Barcelona Barcelona Spain Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06105580 on ClinicalTrials.gov ↗ ← All trials in Spain