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

NCT06474819 | Recruiting FDA Device

• 1 other identifier: DEEP
• Study Type: interventional
• Target: 326
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Complete Heart Block; Second Degree Atrioventricular Block Möbitz Type II

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• LVEF during follow-up

  12 months

• Mitral and tricuspid regurgitation

  12 months

• New York Heart Association (NYHA) class

  12 months

• Brain Natriuretic Peptide levels

  12 months

• heart failure

  12 months

Other Outcomes (1)

• Complications

  12 months

Study Arms (2)

deep

EXPERIMENTAL

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

Apex

ACTIVE COMPARATOR

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

Device: Pacemaker implant

Interventions

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.

Apex; deep

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut d'Investigació Biomèdica de Bellvitge: lead
• Fundació La Marató de TV3: collaborator
• Hospital Universitari de Bellvitge: collaborator

Study Sites (6)

Hospital Vall d'Hebrón

Barcelona, Spain

NOT YET RECRUITING

Hospital General Universitario de Castellón

Castellon, Spain

NOT YET RECRUITING

Hospital Virgen de las Nieves

Granada, Spain

NOT YET RECRUITING

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Spain

RECRUITING

Hospital La Fe

Valencia, Spain

NOT YET RECRUITING

Hospital Lozano Blesa

Zaragoza, Spain

NOT YET RECRUITING

Study Officials

• Andrea Di Marco, MD, PhD

  IDIBELL and Hospital Universitario de Bellvitge

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Di Marco, MD, PhD

CONTACT

+34932 60 75 00; adimarco@bellvitgehospital.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: June 26, 2024
• Study Start: July 12, 2024
• Primary Completion (Estimated): January 12, 2027
• Study Completion (Estimated): January 12, 2027
• Last Updated: July 15, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: During the whole duration of the study
• Access Criteria: Request to the principal investigator.

Locations

ES (6)