Comparing two pacing methods to prevent heart dysfunction
Left Septal Pacing or Left Bundle Branch Pacing to Avoid Left Ventricle Systolic Dysfunction. A Multicenter Randomized Trial From the STAY Investigators
This study is testing if two new pacing methods for heart patients can better protect heart function compared to the traditional method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Parc de Salut Mar Academic / other |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT06707662 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of left septal pacing (LVSP) and left bundle branch pacing (LBBP) against conventional right ventricular apical pacing (RVAP) in patients with high-degree atrioventricular block. The study will involve a multi-center, prospective, randomized design, where participants will be assigned to one of the pacing methods during pacemaker implantation. The primary goal is to determine whether LVSP can better preserve left ventricular function compared to LBBP and RVAP in patients with preserved or mildly deteriorated left ventricular ejection fraction. Outcomes will be assessed over a 12-month period following the procedure.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with preserved or mildly deteriorated left ventricular ejection fraction and a high burden of expected ventricular pacing.
Not a fit: Patients with severe left ventricular dysfunction, those requiring implantable cardioverter defibrillators, or those with recent significant cardiac events may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved heart function and reduced heart failure admissions for patients requiring pacemakers.
How similar studies have performed: Previous studies have shown success with conduction system pacing approaches, indicating potential for this trial's methodology.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age of 18 years or more. 2. Preserved or mild deteriorated LVEF (Simpson \>40%) assessed by a recent (\<1 month before implantation) transthoracic echocardiography. 3. Indication for pacing based on the presence of a high degree AVB, and consequently with an anticipated high burden of ventricular pacing (\>80%). 4. Life expectancy of more than 12 months and capability to understand the protocol, signing informed consent form, and complying with follow-up. Exclusion Criteria: 1. Patients with indication for implantable cardioverter defibrillator device. 2. Patients with indication for a CRT device, with LVEF \<40%. 3. Patients with previous severe LVD (Simpson LVEF \<30%) and a recovered LVEF. 4. History of myocardial infarction/revascularization or cardiac surgery within 6 months before randomization. 5. Pregnancy, active cancer treatment, or participation in another clinical trial with active treatment.
Where this trial is running
Barcelona
- Hospital del Mar - IMIM — Barcelona, Spain (Recruiting)
Study contacts
- Study coordinator: Ermengol Valles, PhD
- Email: ermengolvalles@mac.com
- Phone: 0034666437038
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.