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Left Septal or Deep Septal Pacing to Prevent Pacing-induced Cardiomyopathy | Clinical Trials | Clareo Health

RECRUITINGNA

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

NCT06474819•Institut d'Investigació Biomèdica de Bellvitge

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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.

Locations (6)

Hospital Vall d'Hebrón

Barcelona, Spain

Hospital General Universitario de Castellón

Castellon, Spain

Hospital Virgen de las Nieves

Granada, Spain

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Spain

Hospital La Fe

Valencia, Spain

Hospital Lozano Blesa

Zaragoza, Spain

Key Dates

Start Date

July 12, 2024

Primary Completion Date

January 12, 2027

Completion Date

January 12, 2027

Last Updated

July 15, 2024

Enrollment

326

ESTIMATED participants

Conditions

Complete Heart BlockSecond Degree Atrioventricular Block Möbitz Type II

Interventions

Pacemaker implant

DEVICE

Contacts

Andrea Di Marco, MD, PhD

CONTACT

+34932 60 75 00 adimarco@bellvitgehospital.cat

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 15, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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