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LEft VEntricuLar Activation Time Shortening With Physiological Pacing vs Biventricular Resynchronization Therapy

NCT04054895 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2022-08-04

No results posted yet for this study

Summary

The LEVEL-AT Trial (LEft VEntricuLar Activation Time Shortening with Physiological Pacing vs Biventricular Resynchronization therapy: a randomized study) is a non-inferiority study that aims to determine if physiological pacing could decrease the left ventricular activation time compared with biventricular therapy.

Conditions

  • Physiological Pacing
  • Resynchronization Therapy

Interventions

DEVICE

Lead placed in the His-Purkinje system in order to achieve QRS shortening.

Physiologic pacing to achieve QRS shortening. If the patient has indication of stimulation (AV block), a backup lead will be implanted in the right ventricle. All patients will have a lead placed in the right atrium (except those that have permanent atrial fibrillation).

DEVICE

Lead is placed in a tributary of the coronary sinus.

Biventricular Resynchronization Therapy is the use of a pacemaker with two endocardial leads placed in the right atrium and right ventricle. The third lead is placed in a tributary of the coronary sinus.

Sponsors & Collaborators

  • Institut d'Investigacions Biomèdiques August Pi i Sunyer

    collaborator OTHER

  • Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares (CIBERCV)

    collaborator UNKNOWN

  • Josep Lluis Mont Girbau

    lead OTHER

Principal Investigators

  • Jose M Tolosana, MD, PhD · Hospital Clinic of Barcelona

  • Margarida Pujol Lopez, MD · Hospital Clinic of Barcelona

  • Lluis Mont Girbau, MD, PhD · Hospital Clinic of Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2022-06-30
Completion
2022-06-30
FDA Device
Yes

Countries

  • Spain

Study Locations

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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 NCT04054895 on ClinicalTrials.gov