Cardiomyopathy Clinical Trials

Find Cardiomyopathy Clinical Trials Near You

Left Bundle Branch Area Pacing With a Stylet-Driven Lead Versus Right Ventricular Pacing in Patients With Atrioventricular Block and Preserved Ejection Fraction: A Multicenter Randomized Trial

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Conventional right ventricular pacing (RVP) has been associated with ventricular dyssynchrony and an increased risk of pacing-induced cardiomyopathy, which may lead to worse clinical outcomes. These adverse effects are more pronounced in patients with pre-existing left ventricular dysfunction. To overcome these limitations, left bundle branch area pacing (LBBAP), which directly engages the cardiac conduction system to preserve physiological ventricular activation, has been increasingly adopted in clinical practice. However, in patients with atrioventricular block and preserved left ventricular ejection fraction (LVEF ≥50%), evidence demonstrating the long-term clinical superiority of LBBAP over conventional RVP remains limited. As a result, both pacing strategies continue to be used in current practice. This multicenter randomized trial aims to compare the efficacy, safety, and lead stability of LBBAP using a stylet-driven extendable screw-in lead versus conventional RVP in patients with atrioventricular block and preserved ejection fraction.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

⁃ Patients requiring permanent pacemaker implantation for the following indications:

• Third-degree AV block

• First- or second-degree AV block with an expected ventricular pacing burden ≥40%

• Atrial fibrillation with slow ventricular response with an expected ventricular pacing burden ≥40%

Locations
Other Locations
Republic of Korea
Samsung Changwon Hospital
RECRUITING
Changwon
Samsung Medical Center
RECRUITING
Seoul
Veterans Health Service Medical Center
RECRUITING
Seoul
Wonju Severance Christian Hospital
RECRUITING
Wŏnju
Contact Information
Primary
Seung-Jung Park, MD, PhD
orthovics@gmail.com
82-2-3410-3419
Time Frame
Start Date: 2024-04-29
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 200
Treatments
Experimental: Left bundle branch area pacing
Left bundle branch area pacing performed using a stylet-driven extendable screw-in lead for treatment of atrioventricular block.
Active_comparator: Right ventricular pacing
Conventional right ventricular pacing using a transvenous pacing lead for treatment of atrioventricular block.
Related Therapeutic Areas
Sponsors
Leads: Samsung Medical Center

This content was sourced from clinicaltrials.gov