Comparing two pacing methods for heart failure treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial compares conduction system pacing with biventricular pacing in patients suffering from systolic dysfunction and wide QRS. It aims to evaluate the impact of these two pacing strategies on all-cause mortality, heart failure hospitalizations, and the need for cardiac transplants over a 12-month follow-up period. A total of 320 patients will be randomized to receive either pacing method, and various clinical and echocardiographic parameters will be assessed to determine the effectiveness of each approach. The study also seeks to identify predictors of response to the different pacing strategies using advanced imaging techniques.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital Clínic de Barcelona
  Barcelona, Spain Recruiting

Study contacts

• Principal investigator: José Mª Tolosana, MD, PhD — Hospital Clínic de Barcelona. Institut d'Investigacions Biomèdiques August Pi i Sunyer
• Study coordinator: Jose Mª Tolosana, MD, PhD
• Email: tolosana@clinic.cat
• Phone: 93 2271778 (2094)

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.