The purpose of the study is to investigate the superiority of chronic left bundle branch area pacing compared to traditional right ventricular (RV) septal pacing in patients with high-grade conduction disease after transcatheter aortic valve replacement (TAVR). In this investigator initiated, multicenter, prospective, double-blinded, crossover study, chronic left bundle branch area pacing will be compared to chronic right ventricular septal pacing using echocardiographic measures of left ventricular systolic function in patients with a high cumulative ventricular pacing burden after TAVR.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
46
All patients will undergo implantation of right ventricular septal lead, left bundle branch area lead, and atrial lead in the absence of permanent atrial fibrillation with a CRT-pacing generator. Patients will be randomized to pacing protocols based on group assignment and crossover during the study.
All patients will undergo implantation of right ventricular septal lead, left bundle branch area lead, and atrial lead in the absence of permanent atrial fibrillation with a CRT-pacing generator. Patients will be randomized to pacing protocols based on group assignment and crossover during the study.
Kansas City Heart Rhythm Institute
Overland Park, Kansas, United States
Valley Health System
Ridgewood, New Jersey, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, United States
Change in global longitudinal strain (GLS%)
Primary efficacy outcome
Time frame: 9 months
Change in left ventricular ejection fraction (LVEF%)
Primary efficacy outcome
Time frame: 9 months
Composite of left bundle branch area pacing lead septal myocardial or coronary artery perforation, lead dislodgment, and repeat procedures related to left bundle branch area lead implantation
Primary safety endpoint
Time frame: 18 months
Adverse events related to device function
Time frame: 18 months
Quality of life measured using the Minnesota Living with Heart Failure questionnaire (MLHQ)
Time frame: 9 months
Functional capacity measured using the New York Heart Association functional classification (NYHA)
Time frame: 9 months
Six minute walk test score
Time frame: 9 months
Hospitalizations for heart failure
Time frame: 18 months
Mortality
Time frame: 18 months
Right ventricular global longitudinal strain (RVGLS%)
Time frame: 9 months
Left ventricular mechanical systolic dyssynchrony indexed to heart rate (SDI)
Time frame: 9 months
Interventricular mechanical delay (IVMD)
Time frame: 9 months
Left ventricular end-systolic volume
Time frame: 9 months
Left ventricular stroke volume
Time frame: 9 months
Severity of tricuspid regurgitation
Time frame: 18 months
Severity of mitral regurgitation
Time frame: 18 months
Left bundle branch area pacing lead pacing threshold
Time frame: 18 months
Left bundle branch area pacing lead sensed R wave amplitude
Time frame: 18 months
Left bundle branch area pacing lead impedence
Time frame: 18 months
Brain natriuretic peptide or N-terminal pro-brain natriuretic peptide concentration
Time frame: 9 months
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