Left Bundle Branch Pacing Versus Conventional Pacing in Atrioventricular Block

NCT05129098 | Completed

• 1 other identifier: 251/10-05-21
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Recently, the concept of physiological pacing has emerged in the clinical practice, in an attempt to prevent the deteriorating effects of right ventricular pacing in the long-term. Left bundle branch pacing seems to be a safe procedure with promising results that may prevent intraventricular dyssynchony compared with the conventional right ventricular pacing.

Conditions

Atrioventricular Nodal Disease

Outcome Measures

Primary Outcomes (1)

• Echocardiographic dyssynchrony index, as expressed with Global Left Ventricular Myocardial Work Efficiency (GWE) (%)

  Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and the global left ventricular work efficiency- as a measure of dyssynchrony- will be recorded.

  24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure

Secondary Outcomes (20)

• Procedure Time (min)

  1 Day of procedure

• Fluoroscopy Time (min)

  1 Day of procedure

• Dose Area Product (DAP) (cGy/cm2)

  1 Day of procedure

• Implant success

  1 Day of procedure

• Complications associated with pacemaker implantation

  through study completion at 1 year post randomisation

Study Arms (2)

Left Bundle Branch Pacing

EXPERIMENTAL

Implantation of a left bundle branch lead via sheath, to perform left bundle branch pacing

Device: Left bundle branch pacing lead (Select Secure 3830 lead)

Conventional Right Venticular Pacing

ACTIVE COMPARATOR

The ventricular lead will be implanted in the right ventricle in the conventional way

Device: Right ventricular active fixation lead

Interventions

Left bundle branch pacing lead (Select Secure 3830 lead) DEVICE

Implantation of a left bundle branch pacing lead via sheath

Left Bundle Branch Pacing

Right ventricular active fixation lead DEVICE

Active fixation lead (standard)

Conventional Right Venticular Pacing

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age\>18 years old
• Patients with atrioventricular block and EF\>50% with a predicted ventricular pacing rate\>20%
• Patients with intraventricular septal diameter\>8mm
• Written informed consent

You may not qualify if:

• Indication for CRT or ICD device
• Patients with no subclavian approach, who are candidates for leadless devices
• Presence of severe tricuspid regurgitation
• Patients who are candidates for implantation from the right side, as currently the provided tools for left bundle branch pacing fascilitate only left sided pacemaker implantations

Sponsors & Collaborators

• University Hospital of Patras: lead

Study Sites (1)

University Hospital of Patras

Pátrai, Rion, 26504, Greece

Location

Study Officials

• Georgios Leventopoulos, MD, PhD

  University Hospital of Patras

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principa Investigator

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: November 22, 2021
• Study Start: July 13, 2021
• Primary Completion: December 20, 2022
• Study Completion: December 20, 2022
• Last Updated: October 27, 2023

Record last verified: 2023-10

Locations

GR (1)