Left Septal Pacing or Left Bundle Branch Pacing to Avoid Left Ventricle Systolic Dysfunction

NCT06707662 | Recruiting

• 1 other identifier: 2024/11667/I
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Right ventricular apical pacing (RVAP) can produce left ventricular dysfunction (LVD). Conduction system pacing (CSP) has been used successfully to reverse LVD in patients with left bundle branch block. A recent randomized controlled trial (RCT) has demonstrated that CSP, mostly performed with left bundle branch area pacing (LBBAP), can preserve normal ventricular function and heart failure admissions compared to RVAP in the setting of a high burden of ventricular pacing11 (Stay Trial). Criteria to assess the LBBAP distinguishes those cases in which the LBB is captured (LBBP) from those in which only the muscular septum surrounding the LBB is captured (LVSP). To date, data regarding LVSP to preserve left ventricle ejection fraction (LVEF) is scarce and limited to non-randomized studies.

Conditions

AV Block

Keywords

Conduction System Pacing; Left bundle branch area pacing; Right ventricle apical pacing; Left septum pacing; Left ventricle ejection fraction; Heart failure

Outcome Measures

Primary Outcomes (2)

• LVEF evolution

  Change in the value (%) of LVEF at 12 months compared to basal

  At 12 months after the pacemaker implantation

• Admission due to HF

  Hospital admission due to episode of heart failure (new onset HF or worsening from baseline NYHA)

  From date of implantation until the date of first admission due to HF, whichever came first, assessed up to 12 months

Secondary Outcomes (2)

• LVEED evolution

  At 12 months after the pacemaker implantation

• Admission due to AF

  From date of implantation until the date of first admission due to AF, whichever came first, assessed up to 12 months

Other Outcomes (3)

• Change in ProBNP

  At 12 months after the pacemaker implantation

• NYHA evolution

  At 12 months after the pacemaker implantation

• MLWHFQ evolution

  At 12 months after the pacemaker implantation

Study Arms (3)

Right Ventricle Apical Pacing

ACTIVE COMPARATOR

Standard location for any pacing lead in the right ventricle

Device: Pacemaker and defibrillator

Left bundle branch pacing

EXPERIMENTAL

Stimulation in the Conduction System (righ ventricle) capturing the left budle branch

Device: Pacemaker and defibrillator

Left septal pacing

EXPERIMENTAL

Stimulation in the Conduction System (righ ventricle) without capturing the left budle branch

Device: Pacemaker and defibrillator

Interventions

Pacemaker and defibrillator DEVICE

Pacemaker implantation, which can be a regular right ventricle apical lead or a LBBAP lead (LBBP or LVSP dependint on the criteria accomplished).

Left bundle branch pacing; Left septal pacing; Right Ventricle Apical Pacing

Eligibility Criteria

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

You may qualify if:

• Age of 18 years or more.
• Preserved or mild deteriorated LVEF (Simpson \>40%) assessed by a recent (\<1 month before implantation) transthoracic echocardiography.
• Indication for pacing based on the presence of a high degree AVB, and consequently with an anticipated high burden of ventricular pacing (\>80%).
• Life expectancy of more than 12 months and capability to understand the protocol, signing informed consent form, and complying with follow-up.

You may not qualify if:

• Patients with indication for implantable cardioverter defibrillator device.
• Patients with indication for a CRT device, with LVEF \<40%.
• Patients with previous severe LVD (Simpson LVEF \<30%) and a recovered LVEF.
• History of myocardial infarction/revascularization or cardiac surgery within 6 months before randomization.
• Pregnancy, active cancer treatment, or participation in another clinical trial with active treatment.

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

Hospital del Mar - IMIM

Barcelona, 08003, Spain

RECRUITING

Related Publications (1)

• Gonzalez-Matos CE, Rodriguez-Queralto O, Zaraket F, Jimenez J, Casteigt B, Valles E. Conduction System Stimulation to Avoid Left Ventricle Dysfunction. Circ Arrhythm Electrophysiol. 2024 Feb;17(2):e012473. doi: 10.1161/CIRCEP.123.012473. Epub 2024 Jan 29.

  PMID: 38284238 BACKGROUND

MeSH Terms

Conditions

Atrioventricular Block; Heart Failure

Interventions

Defibrillators

Condition Hierarchy (Ancestors)

Heart Block; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electrodes; Electrical Equipment and Supplies; Equipment and Supplies

Central Study Contacts

Ermengol Valles, PhD

CONTACT

0034666437038; ermengolvalles@mac.com

Jesus Jimenez, MD

CONTACT

0034680714927; jejilo78@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Electrophysiology and Cardiac Stimulation Program

Model Details: The study arm will be defined by randomization immediately before the implantation. Patients randomized to RVAP group will undergo an apex ventricular lead. In patients receiving a LBBAP CSP lead, the procedure will be anatomicaly guided, aiming for a "W" pattern in V1 during septal maping. Operators then will screw the lead, aiming for a moderate drop in the impedance, together with the conversion of the "W" pattern into a qR or rSR pattern in lead V1. The current of injury (COI) will be additionally used as a guide. The cornerstone of this study will be to accept the first location as the final location, as long as unipolar and bipolar thresholds are optimal, and the RBBB pattern in lead V1 remains. To ensure a balanced distribution between LBBP and LVSP, the first operator will not have access to any criteria measurement during the implant procedure, but the morphology in V1. After the procedure investigators will fulfill the Redcap database with all the banned EPRS measurements.

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 27, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD can be available in January of 2027, until January of 2037
• Access Criteria: IPD will be available to any investigator request if the proposal is satisfatory

Locations

ES (1)