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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05541679
Other study ID # E-22-5212
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 28, 2022
Est. completion date December 31, 2025

Study information

Verified date January 2024
Source Main Line Health
Contact Ali Keramati, MD
Phone 484-476-1000
Email keramatia@mlhs.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 46
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Right 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.
Left 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.

Locations

Country Name City State
United States Kansas City Heart Rhythm Institute Overland Park Kansas
United States Hospital of the University of Pennsylvania Philadelphia Pennsylvania
United States Valley Health System Ridgewood New Jersey
United States Lankenau Medical Center Wynnewood Pennsylvania

Sponsors (3)

Lead Sponsor Collaborator
Main Line Health Medtronic, Sharpe-Strumia Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in global longitudinal strain (GLS%) Primary efficacy outcome 9 months
Primary Change in left ventricular ejection fraction (LVEF%) Primary efficacy outcome 9 months
Primary 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 18 months
Secondary Adverse events related to device function 18 months
Secondary Quality of life measured using the Minnesota Living with Heart Failure questionnaire (MLHQ) 9 months
Secondary Functional capacity measured using the New York Heart Association functional classification (NYHA) 9 months
Secondary Six minute walk test score 9 months
Secondary Hospitalizations for heart failure 18 months
Secondary Mortality 18 months
Secondary Right ventricular global longitudinal strain (RVGLS%) 9 months
Secondary Left ventricular mechanical systolic dyssynchrony indexed to heart rate (SDI) 9 months
Secondary Interventricular mechanical delay (IVMD) 9 months
Secondary Left ventricular end-systolic volume 9 months
Secondary Left ventricular stroke volume 9 months
Secondary Severity of tricuspid regurgitation 18 months
Secondary Severity of mitral regurgitation 18 months
Secondary Left bundle branch area pacing lead pacing threshold 18 months
Secondary Left bundle branch area pacing lead sensed R wave amplitude 18 months
Secondary Left bundle branch area pacing lead impedence 18 months
Secondary Brain natriuretic peptide or N-terminal pro-brain natriuretic peptide concentration 9 months
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