Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06105580

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

Led by Hospital Clinic of Barcelona · Updated on 2026-04-03

320

Participants Needed

1

Research Sites

213 weeks

Total Duration

On this page

Sponsors

H

Hospital Clinic of Barcelona

Lead Sponsor

I

Institut d'Investigacions Biomèdiques August Pi i Sunyer

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient must agree to participate by signing informed consent.
  • Patient must be 18 years of age or older.
  • Left bundle branch block with QRS duration of 130 ms or more and LVEF 35% or less, with no need for AV block pacing.
  • Non-left bundle branch block with QRS duration of 150 ms or more and LVEF 35% or less.
  • Indication for resynchronization therapy due to ventricular dysfunction (LVEF less than 40%) and cardiac pacing need for AV block.
  • LVEF 35% or less in NYHA class III or IV, atrial fibrillation, and intrinsic QRS of 130 ms or more with a plan to ensure biventricular capture.
Not Eligible

You will not qualify if you...

  • Myocardial infarction, unstable angina, or cardiac revascularization in the past 3 months.
  • Pregnancy.
  • Currently participating in another clinical trial with active treatment.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hospital Clínic de Barcelona

Barcelona, Spain

Actively Recruiting

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Research Team

J

Jose Mª Tolosana, MD, PhD

CONTACT

M

Margarida Pujol López, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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