Physiological Pacing, Resynchronization Therapy
Conditions
Keywords
Physiological pacing, Resynchronization therapy, Electrocardiographic imaging
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.
Detailed description
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.
Interventions
DEVICELead 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).
DEVICELead 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
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares (CIBERCV)
Josep Lluis Mont Girbau
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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.
Intervention model description
Randomized, unicentric, simple blind.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Left ventricular activation time. | 45 days | Left ventricular activation time measured by eletrocardiographic imaging. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Left ventricular activation time. | 6 months and 12 months. | Left ventricular activation time measured by eletrocardiographic imaging |
| Change in left ventricular function. | 6 months and 12 months. | Left ventricular ejection fraction measured with Simpson method with echocardiography. |
| Change in end-systolic volume. | 6 months and 12 months. | End-systolic volume measured with echocardiography. |
| QRS duration. | Implant, 6 months and 12 months. | QRS duration (milliseconds) measured with a 12-lead ECG. |
| Hospitalization due to heart failure or mortality (combined endpoint). | 1 year. | Hospitalization: patient hospitalization (yes/no) Mortality: mortality (yes/no) |
| Correction of septal flash | 15 days | Correction of septal flash determined with echocardiography (M mode) |
| Change in NYHA functional class. | 6 months and 12 months. | NYHA functional class I, II, III, IV. |
Countries
Spain
Outcome results
None listed