Single-center randomized trial in patients with pacing indication (AV block) after TAVI (transfemoral aortic valve implantation) and LVEF\> 50%, that aims to study the percentage of patients who improve at 12 months in a combined clinical endpoint.
There is currently no evidence of the best mode of definitive pacing after TAVI in patients with preserved systolic ventricular function and AV block. Through this study, investigators intend to elucidate the best post TAVI pacing strategy, comparing the effect of right apical pacing vs. physiological pacing on the evolution of both echocardiographic and clinical parameters. Investigators will include 24 patients without ventricular dysfunction (LVEF\> 50%) and with AV block pacing indication after TAVI. Patients will be randomized to 2 types of pacing (parallel randomized trial): physiological or right ventricular pacing (conventional). PHYS-TAVI trial will analyze the following parameters in the 2 groups: survival; NYHA class; distance in the 6-minute walking test; hospital admissions; left ventricular function; echocardiographic asynchrony (strain and flash septal); NTproBNP; and quality of life/symptoms with the Kansas City Cardiomyopathy Questionnaire test (KCCQ-12) Clinical, and echocardiographic follow-up will be performed for 1 year. Inclusion of 24 more patients to those already included in the context of PHYSTAVI I (NCT04482816). Exploratory trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
Left bundle branch pacing or His bundle branch pacing
Conventional pacing
Hospital Clínic de Barcelona
Barcelona, Spain
RECRUITINGClinical combined endpoint: survival; and improvement > 1 point in NYHA class or > 25% increase in the distance covered in the 6-minute walking test.
Determine the percentage of patients who improve at 12 months on a clinical combined endpoint: survival; and improvement \> 1 point in NYHA class or \> 25% increase in the distance covered in the 6-minute walking test.
Time frame: 12 months
Change in left ventricular ejection fraction.
Left ventricular ejection fraction (LVEF %) measured with Simpson method with echocardiography (Delta left ventricular ejection fraction: 12 months LVEF - baseline LVEF).
Time frame: 12 months.
Correction of echocardiographic asynchrony: septal flash expressed in mm.
Correction of septal flash determined with echocardiography (M mode).
Time frame: 30 days; 12 months.
Distance covered in the 6-minute walking test.
Distance in meters walked in 6 minutes.
Time frame: 30 days; 12 months.
Change in NYHA (New York Heart Association) functional class.
NYHA functional class I, II, III, IV.
Time frame: 30 days; 12 months.
Change in degree of mitral regurgitation.
Mitral regurgitation (MR) measured with echocardiography. The severity of MR graded as absent (0), mild (1), moderate (2), moderate-severe (3), or severe (4).
Time frame: 30 days; 12 months.
Change in NTproBNP.
NTproBNP blood levels.
Time frame: Baseline; 12 months.
Hospitalization due to heart failure.
Hospitalization: patient hospitalization (yes/no).
Time frame: 12 months.
QRS duration.
QRS duration (milliseconds) measured with a 12-lead ECG (200mm/s).
Time frame: Baseline
Score on quality of life/symptoms Questionnaire (KCCQ-12 Kansas City Cardiomyopathy Questionnaire).
Score in Kansas City Cardiomyopathy Questionnaire-12: (higher=better).
Time frame: 30 days; 12 months.
Correction of global longitudinal strain
Global longitudinal strain assessed with two-dimensional speckle-tracking echocardiography
Time frame: 30 days; 12 months
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