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NCT Number: NCT04054895

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

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.

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Key information

Conditions

Physiological Pacing Resynchronization Therapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clinic de Barcelona

Barcelona, Select, 08036, Spain

About this study

To date studies have showed that physiological pacing could get similar clinical and echocardiographic response to that obtained with biventricular therapy. Activation time shortening with permanent physiological pacing has not been studied.

This study will randomize 70 patients to a strategy of: biventricular pacing versus physiological pacing.

LEVEL-AT study will analyze the following parameters in the 2 groups: shortening of the QRS, activation time with electrocardiographic imaging, echocardiographic asynchrony and ventricular function and clinical parameters (NYHA functional class, mortality and heart failure hospitalization).

Clinical, electrocardiographic, echocardiographic and electrocardiographic imaging follow-up will be performed for 1 year.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patient must indicate their acceptance to participate in the study by signing an informed consent document.
  • The patient must be ≥ 18 years of age.
  • Left bundle branch block, QRS ≥130 and FEVI <=35% (Indication of cardiac resynchronization IA or IB ESC Guidelines). No indication of stimulation for AV block.
  • Patients with indication of resynchronization therapy for ventricular dysfunction and indication of cardiac stimulation for AV block according to ESC Guidelines (IA ESC Guidelines).
  • Non-left bundle branch block, QRS ≥150 and FEVI <=35% (Indication of cardiac resynchronization IIaB ESC Guidelines).

Exclusion criteria

  • Myocardial infarction, unstable angina or cardiac revascularization during the previous 3 months.
  • Pregnancy.
  • Participating currently in a clinical investigation that includes an active treatment.

Treatment and study plan

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

Device

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).

Lead is placed in a tributary of the coronary sinus.

Device

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.

Primary outcomes

  1. Left ventricular activation time.

    Time frame: 45 days

    Left ventricular activation time measured by eletrocardiographic imaging.

Secondary outcomes

  1. QRS duration.

    Time frame: Implant, 6 months and 12 months.

    QRS duration (milliseconds) measured with a 12-lead ECG.

  2. Left ventricular activation time.

    Time frame: 6 months and 12 months.

    Left ventricular activation time measured by eletrocardiographic imaging

  3. Change in left ventricular function.

    Time frame: 6 months and 12 months.

    Left ventricular ejection fraction measured with Simpson method with echocardiography.

  4. Change in end-systolic volume.

    Time frame: 6 months and 12 months.

    End-systolic volume measured with echocardiography.

  5. Change in NYHA functional class.

    Time frame: 6 months and 12 months.

    NYHA functional class I, II, III, IV.

  6. Hospitalization due to heart failure or mortality (combined endpoint).

    Time frame: 1 year.

    Hospitalization: patient hospitalization (yes/no) Mortality: mortality (yes/no)

  7. Correction of septal flash

    Time frame: 15 days

    Correction of septal flash determined with echocardiography (M mode)

Sponsors and collaborators

Lead sponsor

Josep Lluis Mont Girbau

Other

Collaborators

  • Consorcio Centro de Investigación Biomédica en Red (CIBER)
  • Institut d'Investigacions Biomèdiques August Pi i Sunyer

Registry information

Official study title

LEft VEntricuLar Activation Time Shortening With Physiological Pacing vs Biventricular Resynchronization Therapy: a Randomized Study (LEVEL-AT)

Acronym: LEVEL-AT

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 13, 2019
Registry last updated
Aug 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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