Aortic Valve Stenosis, Complete Heart Block, High Degree Second Degree Atrioventricular Block, Pacemaker-Induced Cardiomyopathy
Conditions
Brief summary
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.
Interventions
DEVICERight ventricular septal pacing followed by left bundle branch area pacing
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.
DEVICELeft bundle branch area pacing followed by right ventricular septal pacing
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.
Sponsors
Sharpe-Strumia Research Foundation
Medtronic
Main Line Health
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject has at least one of these conduction disturbances: 1. Symptomatic (or hemodynamically significant) bradycardia or symptomatic persistent atrioventricular block including first-degree and Mobitz I (Wenckebach) or Mobitz type II atrioventricular bock 2. High-grade atrioventricular block 3. Third-degree atrioventricular block * Subject has undergone TAVR (any valve system) in the last four weeks * Subject is receiving a first-time pacemaker implant * Subject's most recent documented ejection fraction (by any method) within the past 90 days prior to study enrollment is \> 50% (≥45% if visually estimated at the time of enrollment) * Subject is a male or female at least 18 years old at the time of consent * Subject is able to receive a left sided pectoral implant
Exclusion criteria
* Subject has ever had a previous or has an existing implantable pulse generator (IPG), implantable cardiac defibrillator (ICD) or biventricular (BiV) implant * Subject has more than mild para-valvular regurgitation following TAVR implantation. * Subject has LVEF \< 45% if visually estimated at the time of enrollment * Subject is indicated for a biventricular pacing device (CRT-P or CRT-D). * Subject is enrolled in a concurrent study that may confound the results of this study * Subject has a mechanical heart valve * Subject is pregnant, or of childbearing potential and not on a reliable form of birth control * Subject status post heart transplant * Subject life expectancy less than 2 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in global longitudinal strain (GLS%) | 9 months | Primary efficacy outcome |
| Change in left ventricular ejection fraction (LVEF%) | 9 months | Primary efficacy outcome |
| 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 | 18 months | Primary safety endpoint |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life measured using the Minnesota Living with Heart Failure questionnaire (MLHQ) | 9 months |
| Functional capacity measured using the New York Heart Association functional classification (NYHA) | 9 months |
| Six minute walk test score | 9 months |
| Hospitalizations for heart failure | 18 months |
| Mortality | 18 months |
| Right ventricular global longitudinal strain (RVGLS%) | 9 months |
| Left ventricular mechanical systolic dyssynchrony indexed to heart rate (SDI) | 9 months |
| Left ventricular stroke volume | 9 months |
| Left ventricular end-systolic volume | 9 months |
| Severity of mitral regurgitation | 18 months |
| Left bundle branch area pacing lead pacing threshold | 18 months |
| Left bundle branch area pacing lead sensed R wave amplitude | 18 months |
| Left bundle branch area pacing lead impedence | 18 months |
| Brain natriuretic peptide or N-terminal pro-brain natriuretic peptide concentration | 9 months |
| Interventricular mechanical delay (IVMD) | 9 months |
| Severity of tricuspid regurgitation | 18 months |
| Adverse events related to device function | 18 months |
Countries
United States
Outcome results
None listed