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NCT Number: NCT06474819

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

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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Key information

Conditions

Complete Heart Block Second Degree Atrioventricular Block Möbitz Type II

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Vall d'Hebrón, Barcelona, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Pacing-induced cardiomyopathy

    Time frame: 12 months

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

Secondary outcomes

  1. LVEF during follow-up

    Time frame: 12 months

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

  2. Mitral and tricuspid regurgitation

    Time frame: 12 months

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

  3. New York Heart Association (NYHA) class

    Time frame: 12 months

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

  4. Brain Natriuretic Peptide levels

    Time frame: 12 months

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

  5. heart failure

    Time frame: 12 months

    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.

Other outcomes

  1. Complications

    Time frame: 12 months

    Complications related to the ventricular lead

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Di Marco, MD, PhD

CONTACT

[email protected]

+34932 60 75 00 ext. 8385

Sponsors and collaborators

Lead sponsor

Institut d'Investigació Biomèdica de Bellvitge

Other

Collaborators

  • Fundació La Marató de TV3
  • Hospital Universitari de Bellvitge

Registry information

Acronym: DEEP

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 26, 2024
Registry last updated
Jul 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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