Comparing two pacing methods for heart failure treatment
Conduction System Pacing vs Biventricular Resynchronization Therapy in Systolic Dysfunction and Wide QRS: Mortality, Heart Failure Hospitalization or Cardiac Transplant
NA · Hospital Clinic of Barcelona · NCT06105580
This study is testing which pacing method, conduction system pacing or biventricular pacing, works better for people with heart failure to see if it can help them live longer and avoid hospital visits.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 320 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Clinic of Barcelona (other) |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT06105580 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with specific types of heart block and reduced left ventricular ejection fraction.
Not a fit: Patients with recent myocardial infarction, unstable angina, or those currently pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into more effective pacing strategies for patients with heart failure, potentially improving survival and quality of life.
How similar studies have performed: Previous studies have shown promising results for conduction system pacing, suggesting potential benefits similar to those of biventricular pacing, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Barcelona
- 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)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cardiac Resynchronization Therapy, Heart Failure, left bundle branch pacing, biventricular pacing, cardiac resynchronization therapy