Left Septal or Deep Septal Pacing to Prevent Pacing-induced Cardiomyopathy (DEEP)

Institut d'Investigació Biomèdica de Bellvitge

Status: Enrolling

Conditions: Complete Heart Block; Second Degree Atrioventricular Block Möbitz Type II

Treatments: Device: Pacemaker implant

Study type: Interventional

Funder types: Other

Identifiers

NCT06474819

DEEP

Details and patient eligibility

About

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.

Enrollment: 326 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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326 participants in 2 patient groups

deep

Experimental group

Description:

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.

Treatment:

Device: Pacemaker implant

Apex

Active Comparator group

Description:

The ventricular lead will be placed in the right ventricular apex.

Treatment:

Device: Pacemaker implant