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

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.

Study Overview

• Status: Recruiting
• Conditions: Complete Heart Block; Second Degree Atrioventricular Block Möbitz Type II
• Intervention / Treatment: Device: Pacemaker implant

• Study Type: Interventional
• Enrollment (Estimated): 326
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrea Di Marco, MD, PhD; Phone Number: 8385 +34932 60 75 00; Email: adimarco@bellvitgehospital.cat

Study Locations

• Spain
  • Barcelona, Spain
    • Not yet recruiting
    • Hospital Vall d'Hebron
    • Contact: Raquel Adeliño Recasens
  • Castellón De La Plana, Spain
    • Not yet recruiting
    • Hospital General Universitario de Castellon
    • Contact: Clara Gunturiz Beltrán
  • Granada, Spain
    • Not yet recruiting
    • Hospital Virgen de las Nieves
    • Contact: Manuel Molina Lerma
  • Hospitalet de Llobregat, Spain
    • Recruiting
    • Hospital Universitario de Bellvitge
    • Contact: Andrea Di Marco; Email: adimarco@bellvitgehospital.cat
  • Valencia, Spain
    • Not yet recruiting
    • Hospital la Fé
    • Contact: Oscar Cano Perez
  • Zaragoza, Spain
    • Not yet recruiting
    • Hospital Lozano Blesa
    • Contact: Javier Ramos Maqueda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.
Active Comparator: Apex; The ventricular lead will be placed in the right ventricular apex.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	12 months
New York Heart Association (NYHA) class	To compare the NYHA class one year after pacemaker implant in the two groups.	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.	12 months
heart failure	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.	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Complications related to the ventricular lead	12 months

Collaborators and Investigators

• Sponsor: Institut d'Investigació Biomèdica de Bellvitge
• Collaborators: Hospital Universitari de Bellvitge; Fundació La Marató de TV3
• Investigators: Principal Investigator: Andrea Di Marco, MD, PhD, IDIBELL and Hospital Universitario de Bellvitge

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2024
• Primary Completion (Estimated): January 12, 2027
• Study Completion (Estimated): January 12, 2027

Study Registration Dates

• First Submitted: June 19, 2024
• First Submitted That Met QC Criteria: June 25, 2024
• First Posted (Actual): June 26, 2024

Study Record Updates

• Last Update Posted (Actual): July 15, 2024
• Last Update Submitted That Met QC Criteria: July 12, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Heart Block; Cardiomyopathies; Atrioventricular Block
• Other Study ID Numbers: DEEP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study protocol and the informed consent form will be available upon request during the whole duration of the study.
• IPD Sharing Time Frame: During the whole duration of the study
• IPD Sharing Access Criteria: Request to the principal investigator.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes