NCT06474819

Left Septal or Deep Septal Pacing to Prevent Pacing-induced Cardiomyopathy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 326 (estimated)
• Sponsor: Institut d'Investigació Biomèdica de Bellvitge · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Multicenter randomized controlled trial which will include patients with left ventricular ejection fraction \>50% requiring a first implant of a cardiac pacemaker with expected high pacing percentages. Patients will be randomized 1:1 to right ventricular apical pacing vs left septal or deep septal pacing. The primary endpoint will be pacing-induced cardiomyopathy during the first year of follow-up.

Conditions

• Complete Heart Block
• Second Degree Atrioventricular Block Möbitz Type II

Interventions

Type	Name	Description
DEVICE	Pacemaker implant	All patients in the study will have a clear indication for a permanent pacemaker. The type of device (single or dual chamber) will be chosen as per clinical practice. The only difference between the two groups of the study will be the position of the ventricular lead.

Timeline

• Start date: 2024-07-12
• Primary completion: 2027-01-12
• Completion: 2027-01-12
• First posted: 2024-06-26
• Last updated: 2024-07-15

Locations

6 sites across 1 country: Spain

Regulatory

• FDA-regulated device study