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

NCT04054895 | Completed FDA Device

• 1 other identifier: LEVEL-AT
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Physiological pacing; Resynchronization therapy; Electrocardiographic imaging

Outcome Measures

Primary Outcomes (1)

• Left ventricular activation time.

  Left ventricular activation time measured by eletrocardiographic imaging.

  45 days

Secondary Outcomes (7)

• QRS duration.

  Implant, 6 months and 12 months.

• Left ventricular activation time.

  6 months and 12 months.

• Change in left ventricular function.

  6 months and 12 months.

• Change in end-systolic volume.

  6 months and 12 months.

• Change in NYHA functional class.

  6 months and 12 months.

Study Arms (2)

Physiological pacing

EXPERIMENTAL

Pacing the his-purkinje system. Crossover to biventricular CRT will be allowed in the following situations: failed physiological pacing lead implantation; high thresholds (\>3.5V / 1ms); no shortening of QRS (shortening \<20%) or failure to meet non-selective HBP criteria \[Europace. 2019 Oct 9. doi: 10.1093/europace/euz275\].

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

Biventricular resynchronization therapy

ACTIVE COMPARATOR

Pacing from the right ventricular and coronary sinus leads. Electrocardiographic optimization with fusion-optimized intervals. Crossover from biventricular CRT to physiological pacing will be allowed in the following situations: coronary sinus cannot be cannulated; no lateral or posterolateral branches; or phrenic stimulation.

Device: Lead is placed in a tributary of the coronary sinus.

Interventions

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).

Physiological pacing

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.

Biventricular resynchronization therapy

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Josep Lluis Mont Girbau: lead
• Institut d'Investigacions Biomèdiques August Pi i Sunyer: collaborator
• Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares (CIBERCV): collaborator

Study Sites (1)

Hospital Clinic de Barcelona

Barcelona, Select, 08036, Spain

Location

Related Publications (2)

• Pujol-Lopez M, Ferro E, Borras R, Garre P, Guasch E, Jimenez-Arjona R, Garcia-Ribas C, Doltra A, Niebla M, Carro E, Roca-Luque I, Guichard JB, Puente JL, Uribe L, Vazquez-Calvo S, Castel MA, Arbelo E, Porta-Sanchez A, Sitges M, Tolosana JM, Mont L. Stepwise application of ECG and electrogram-based criteria to ensure electrical resynchronization with left bundle branch pacing. Europace. 2023 Jun 2;25(6):euad128. doi: 10.1093/europace/euad128.

  PMID: 37294671 DERIVED

• Pujol-Lopez M, Jimenez-Arjona R, Garre P, Guasch E, Borras R, Doltra A, Ferro E, Garcia-Ribas C, Niebla M, Carro E, Puente JL, Vazquez-Calvo S, Invers-Rubio E, Roca-Luque I, Castel MA, Arbelo E, Sitges M, Brugada J, Tolosana JM, Mont L. Conduction System Pacing vs Biventricular Pacing in Heart Failure and Wide QRS Patients: LEVEL-AT Trial. JACC Clin Electrophysiol. 2022 Nov;8(11):1431-1445. doi: 10.1016/j.jacep.2022.08.001. Epub 2022 Oct 26.

  PMID: 36424012 DERIVED

Study Officials

• Jose M Tolosana, MD, PhD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

• Margarida Pujol Lopez, MD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

• Lluis Mont Girbau, MD, PhD

  Hospital Clinic of Barcelona

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patient will be explained to be randomized to either of the two branches. The type of therapy applied will not be communicated to the patient. The follow-up will be the same in the two branches. During the visits it will not be said which therapy has been applied.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Arrhythmia Section. Professor of Cardiology

Model Details: Randomized, unicentric, simple blind.

Study Record Dates

• First Submitted: August 7, 2019
• First Posted: August 13, 2019
• Study Start: September 1, 2019
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: August 4, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)