NCT06674967

Brief Summary

This study will address whether LBBaP is superior to RVAP in terms of safety and efficacy

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
15mo left

Started Nov 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Nov 2024Aug 2027

First Submitted

Initial submission to the registry

October 14, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 5, 2024

Completed
25 days until next milestone

Study Start

First participant enrolled

November 30, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

November 5, 2024

Status Verified

November 1, 2024

Enrollment Period

1.8 years

First QC Date

October 14, 2024

Last Update Submit

November 4, 2024

Conditions

Atrio-Ventricular Block

Keywords

EfficacySafetyRV apical pacingLBB area pacingAtrioventricular block

Outcome Measures

Primary Outcomes (3)

  • effectiveness with LBB pacing

    Assess left ventricular global strain using speckle tracking echocardiography (percentage)

    3 years

  • Incidence of adverse events in patient with LBB pacing

    Malignant arrhythmia(Yes/No)

    3 years

  • Incidence of septal perforation

    Detect septal perforation(Yes/No)

    3 years

Secondary Outcomes (1)

  • Major Adverse Cardiovascular Events

    3 years

Study Arms (2)

LBB area pacing group

study group with LBB area pacing

RV apical pacing area

study group with RV apical pacing

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

. Patients with AVB who meet indications for pacemaker , with an estimated percentage of ventricular pacing ≥50%

You may qualify if:

  • Patients with AVB who meet indications for pacemaker
  • Implantation with an estimated percentage of ventricular pacing ≥50%
  • Ability to provide informed consent

You may not qualify if:

  • Failure to cooperate with follow-up.
  • Persistent atrial fibrillation.
  • Patients with heart failure (LVEF) ≤35%,
  • Estimated glomerular filtration rate less than 30 ml/min.
  • Septic shock
  • advanced malignant tumor.
  • Pregnancy or prepared to get pregnant
  • Cardiac tamponade or major hemopericardium

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, Asyut Governorate, 71515, Egypt

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

venous blood sample for routine investigations as in complete blood count

MeSH Terms

Conditions

Atrioventricular Block

Condition Hierarchy (Ancestors)

Heart BlockArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

October 14, 2024

First Posted

November 5, 2024

Study Start

November 30, 2024

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 1, 2027

Last Updated

November 5, 2024

Record last verified: 2024-11

Locations

EG(1)