NCT06105580 Conduction System Pacing vs Biventricular Pacing in Systolic Dysfunction and Wide QRS: Mortality, Heart Failure Hospitalization or Cardiac Transplant
| NCT ID | NCT06105580 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Clinic of Barcelona |
| Condition | Cardiac Resynchronization Therapy |
| Study Type | INTERVENTIONAL |
| Enrollment | 320 participants |
| Start Date | 2023-11-27 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 320 participants in total. It began in 2023-11-27 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
José Mª Tolosana, MD, PhD
PRINCIPAL INVESTIGATOR
Hospital Clínic de Barcelona. Institut d'Investigacions Biomèdiques August Pi i Sunyer
Frequently Asked Questions
Who can join the NCT06105580 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiac Resynchronization Therapy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06105580 currently recruiting?
Yes, NCT06105580 is actively recruiting participants. Contact the research team at tolosana@clinic.cat for enrollment information.
Where is the NCT06105580 trial being conducted?
This trial is being conducted at Barcelona, Spain.
Who is sponsoring the NCT06105580 clinical trial?
NCT06105580 is sponsored by Hospital Clinic of Barcelona. The principal investigator is José Mª Tolosana, MD, PhD at Hospital Clínic de Barcelona. Institut d'Investigacions Biomèdiques August Pi i Sunyer. The trial plans to enroll 320 participants.