Left Septal Pacing or Left Bundle Branch Pacing to Avoid Left Ventricle Systolic Dysfunction. A Multicenter Randomized Trial From the STAY Investigators

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Right ventricular apical pacing (RVAP) can produce left ventricular dysfunction (LVD). Conduction system pacing (CSP) has been used successfully to reverse LVD in patients with left bundle branch block. A recent randomized controlled trial (RCT) has demonstrated that CSP, mostly performed with left bundle branch area pacing (LBBAP), can preserve normal ventricular function and heart failure admissions compared to RVAP in the setting of a high burden of ventricular pacing11 (Stay Trial). Criteria to assess the LBBAP distinguishes those cases in which the LBB is captured (LBBP) from those in which only the muscular septum surrounding the LBB is captured (LVSP). To date, data regarding LVSP to preserve left ventricle ejection fraction (LVEF) is scarce and limited to non-randomized studies.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age of 18 years or more.

• Preserved or mild deteriorated LVEF (Simpson \>40%) assessed by a recent (\<1 month before implantation) transthoracic echocardiography.

• Indication for pacing based on the presence of a high degree AVB, and consequently with an anticipated high burden of ventricular pacing (\>80%).

• Life expectancy of more than 12 months and capability to understand the protocol, signing informed consent form, and complying with follow-up.

Locations
Other Locations
Spain
Hospital del Mar - IMIM
RECRUITING
Barcelona
Contact Information
Primary
Ermengol Valles, PhD
ermengolvalles@mac.com
0034666437038
Backup
Jesus Jimenez, MD
jejilo78@gmail.com
0034680714927
Time Frame
Start Date: 2025-01-01
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 150
Treatments
Active_comparator: Right Ventricle Apical Pacing
Standard location for any pacing lead in the right ventricle
Experimental: Left bundle branch pacing
Stimulation in the Conduction System (righ ventricle) capturing the left budle branch
Experimental: Left septal pacing
Stimulation in the Conduction System (righ ventricle) without capturing the left budle branch
Related Therapeutic Areas
Sponsors
Leads: Parc de Salut Mar

This content was sourced from clinicaltrials.gov