Randomized Study of Physiological versus Right Ventricular Pacing in Patients with Normal Ventricular Function After Transfemoral Aortic Valve Implantation (PHYSTAVI II)

What this Trial Is About

Researchers are evaluating the best pacing method for patients who have undergone transfemoral aortic valve implantation (TAVI) and have a normal left ventricular ejection fraction (LVEF > 50%) but require pacing due to atrioventricular (AV) block. This study compares physiological pacing, which targets the His-Purkinje system, to conventional right ventricular pacing. The goal is to determine which pacing method leads to better clinical and echocardiographic outcomes over 12 months. The trial involves 24 patients randomized into two groups: one receiving physiological pacing via leads placed in the His or left bundle branch aiming to shorten the QRS complex, and the other receiving conventional right ventricular pacing. Crossover from physiological to right ventricular pacing is allowed if physiological pacing fails. The study will monitor survival, heart function, walking ability, hospital admissions, heart failure biomarkers, and quality of life during a one-year follow-up. Participants will undergo clinical and echocardiographic evaluations at baseline, 30 days, and 12 months, including tests such as the 6-minute walking test, NYHA class assessment, echocardiographic strain and synchrony measures, NT-proBNP levels, and the Kansas City Cardiomyopathy Questionnaire. The primary outcome is a combined clinical endpoint of survival and improvement in symptoms or exercise capacity after 12 months. The study includes careful monitoring of heart function and quality of life changes throughout the year-long participation.

Randomized Study of Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post TAVI