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

Not Applicable

Recruiting

• Conditions: Complete Heart Block; Second Degree Atrioventricular Block Möbitz Type II
• Interventions: Device: Pacemaker implant

• Registration Number: NCT06474819
• Lead Sponsor: Institut d'Investigació Biomèdica de Bellvitge

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-19
• Study First Submitted QC: 2024-06-25
• Study First Posted: 2024-06-26
• Status Verified: 2024-07
• Study Start: 2024-07-12
• Last Update Submitted: 2024-07-12
• Last Update Posted: 2024-07-15
• Primary Completion: 2027-01-12
• Study Completion: 2027-01-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 326

Inclusion Criteria

• 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.

Exclusion Criteria

• Life expectancy <12 months
• Severe cardiac valvular abnormality requiring intervention
• Unstable Angina, Acute myocardial infarction, coronary revascularization, valvular surgery or valvular percutaneous intervention in the 90 days prior to pacemaker implant.
• Inclusion in another trial which may influence the results of this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Apex	Pacemaker implant	The ventricular lead will be placed in the right ventricular apex.
deep	Pacemaker implant	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.

Primary Outcome Measures

Name	Time	Method
Pacing-induced cardiomyopathy	12 months	Decrease in the left ventricular ejection fraction (LVEF) by \>10% as compared to the LVEF before pacemaker implant and final LVEF\<45%.

Secondary Outcome Measures

Name	Time	Method
heart failure	12 months	Comparison of heart failure (HF) events in the first year after pacemaker implant in the two groups. HF events will be: hospitalizations for heart failure, emergency department or day-hospital visits for heart failure, heart failure symptoms requiring the initiation of diuretic therapy.
LVEF during follow-up	12 months	To compare the mean or median (depending on distribution) LVEF before and one year after pacemaker implant in the two groups.
Mitral and tricuspid regurgitation	12 months	To compare the degree of mitral and tricuspid regurgitation before and one year after pacemaker implant in the two groups.
Brain Natriuretic Peptide levels	12 months	To compare the N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels one year after pacemaker implant in the two groups.
New York Heart Association (NYHA) class	12 months	To compare the NYHA class one year after pacemaker implant in the two groups.

Trial Locations

Locations (6)

Hospital La Fe; 🇪🇸 Valencia, Spain

Hospital General Universitario de Castellón; 🇪🇸 Castellón De La Plana, Spain

Hospital Vall d'Hebrón; 🇪🇸 Barcelona, Spain

Hospital Universitario de Bellvitge; 🇪🇸 Hospitalet de Llobregat, Spain

Hospital Lozano Blesa; 🇪🇸 Zaragoza, Spain

Hospital Virgen de las Nieves; 🇪🇸 Granada, Spain