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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

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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