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

Institut d'Investigació Biomèdica de Bellvitge326 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

326

Conditions

Complete Heart Block Second Degree Atrioventricular Block Möbitz Type II

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (6)

Hospital Vall d'Hebrón

Barcelona, Spain

NOT_YET_RECRUITING

Hospital General Universitario de Castellón

Castellon, Spain

NOT_YET_RECRUITING

Hospital Virgen de las Nieves

Granada, Spain

NOT_YET_RECRUITING

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Spain

RECRUITING

Hospital La Fe

Valencia, Spain

NOT_YET_RECRUITING

Hospital Lozano Blesa

Zaragoza, Spain

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

Pacing-induced cardiomyopathy

Decrease in the left ventricular ejection fraction (LVEF) by \>10% as compared to the LVEF before pacemaker implant and final LVEF\<45%.

Time frame: 12 months

Secondary Outcomes

LVEF during follow-up

To compare the mean or median (depending on distribution) LVEF before and one year after pacemaker implant in the two groups.

Time frame: 12 months

Mitral and tricuspid regurgitation

To compare the degree of mitral and tricuspid regurgitation before and one year after pacemaker implant in the two groups.

Time frame: 12 months

New York Heart Association (NYHA) class

To compare the NYHA class one year after pacemaker implant in the two groups.

Time frame: 12 months

Brain Natriuretic Peptide levels

To compare the N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels one year after pacemaker implant in the two groups.

Time frame: 12 months

heart failure

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.

Time frame: 12 months

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

Overview

Conditions

Interventions

Eligibility

Locations (6)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts