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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

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

• First implant of a single-chamber or dual chamber pacemaker due to persistent bradycardia associated with high degree atrio-ventricular (AV) block (complete AV block or second degree type II AV block), with second-degree type I AV block (symptomatic or associated with intra-hisian or infra-hisian block), or with atrial fibrillation with symptomatic slow ventricular rate (\<45lpm).

• LVEF\>50% at echocardiography performed maximum 7 days before pacemaker implant.

• Informed consent signature.

Locations
Other Locations
Spain
Hospital Vall d'Hebrón
NOT_YET_RECRUITING
Barcelona
Hospital General Universitario de Castellón
NOT_YET_RECRUITING
Castellon
Hospital Virgen de las Nieves
NOT_YET_RECRUITING
Granada
Hospital Universitario de Bellvitge
RECRUITING
L'hospitalet De Llobregat
Hospital La Fe
NOT_YET_RECRUITING
Valencia
Hospital Lozano Blesa
NOT_YET_RECRUITING
Zaragoza
Contact Information
Primary
Andrea Di Marco, MD, PhD
adimarco@bellvitgehospital.cat
+34932 60 75 00
Time Frame
Start Date: 2024-07-12
Estimated Completion Date: 2027-01-12
Participants
Target number of participants: 326
Treatments
Experimental: deep
The ventricular lead will be penetrated into the basal interventricular septum aiming at left septal pacing and, if not possible, at least deep septal pacing with a paced QRS duration \<=140ms.
Active_comparator: Apex
The ventricular lead will be placed in the right ventricular apex.
Related Therapeutic Areas
Sponsors
Leads: Institut d'Investigació Biomèdica de Bellvitge
Collaborators: Hospital Universitari de Bellvitge, Fundació La Marató de TV3

This content was sourced from clinicaltrials.gov