MedTrace Logo

Conduction System Stimulation to Avoid Left Ventricle Dysfunction

NCT06026683 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2024-04-03

No results posted yet for this study

Summary

The aim of the study is to demonstrate that conduction system pacing (CSP) can preserve a normal ventricular function compared to right ventricular apical pacing (RVAP) in patients with pre-implant preserved left ventricular ejection fraction (LVEF) and a high burden of expected ventricular pacing due to atrioventricular conduction block (AV block).

After informed consent signature, patients with high degree AV block and normal LVEF will be randomized to permanent pacemaker stimulation with CSP vs RVAP.

All the patients have a complete evaluation before the procedure and at 3 and 6 months follow-up.

Conditions

  • Atrioventricular Block, Second and Third Degree
  • Pacemaker-Induced Cardiomyopathy
  • Heart Failure

Interventions

DEVICE

Pacemaker implant

Implantation of pacemaker with conduction system pacing or right ventricular apical pacing

Sponsors & Collaborators

  • Parc de Salut Mar

    lead OTHER

Principal Investigators

  • Ermengol Vallès, PhD · Parc de Salut Mar

  • Carlos González, M.D. · Parc de Salut Mar. Universitat Autónoma de Barcelona.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-30
Primary Completion
2023-10-02
Completion
2023-11-30
FDA Device
Yes

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06026683 on ClinicalTrials.gov