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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

326 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-12

Study Completion Date

2027-01-12

Brief Summary

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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.

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Detailed Description

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Conditions

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Complete Heart Block Second Degree Atrioventricular Block Möbitz Type II

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Pacemaker implant

Intervention Type 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.

Apex

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

Group Type ACTIVE_COMPARATOR

Pacemaker implant

Intervention Type 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.

Interventions

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Pacemaker implant

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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Andrea Di Marco

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea Di Marco, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

IDIBELL and Hospital Universitario de Bellvitge

Locations

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