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

ConditionsComplete Heart Block Second Degree Atrioventricular Block Möbitz Type II

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorInstitut d'Investigació Biomèdica de Bellvitge

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Pacemaker implant
Device
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.

Treatment groups

326 Participants

are divided into 2 treatment groups

Group A: deepExperimental treatment 1 intervention

Group B: ApexActive comparator 1 intervention

Trial 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

Other outcomes

Complications

Complications related to the ventricular lead

Time frame

12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institut d'Investigació Biomèdica de Bellvitge

Lead sponsor

Fundació La Marató de TV3

Collaborator

Hospital Universitari de Bellvitge

Collaborator

Source ClinicalTrials.gov

Apply now