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| Name | Class |
|---|---|
| Institut d'Investigacions Biomèdiques August Pi i Sunyer | OTHER |
| Consorcio Centro de Investigación Biomédica en Red (CIBER) | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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]. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Left ventricular activation time. | Left ventricular activation time measured by eletrocardiographic imaging. | 45 days |
| Measure | Description | Time Frame |
|---|---|---|
| QRS duration. | QRS duration (milliseconds) measured with a 12-lead ECG. | Implant, 6 months and 12 months. |
| Left ventricular activation time. | Left ventricular activation time measured by eletrocardiographic imaging |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic de Barcelona | Barcelona | Select | 08036 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37294671 | Derived | 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. | |
| 36424012 |
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Randomized, unicentric, simple blind.
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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.
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| 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. |
|
| 6 months and 12 months. |
| Change in left ventricular function. | Left ventricular ejection fraction measured with Simpson method with echocardiography. | 6 months and 12 months. |
| Change in end-systolic volume. | End-systolic volume measured with echocardiography. | 6 months and 12 months. |
| Change in NYHA functional class. | NYHA functional class I, II, III, IV. | 6 months and 12 months. |
| Hospitalization due to heart failure or mortality (combined endpoint). | Hospitalization: patient hospitalization (yes/no) Mortality: mortality (yes/no) | 1 year. |
| Correction of septal flash | Correction of septal flash determined with echocardiography (M mode) | 15 days |
| 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. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 16, 2023 | Sep 13, 2023 | 5 |