This is a prospective, randomized controlled (1:1) multicenter trial. The pilot study will be conducted up to three clinical sites in the United States. The primary purpose of this study is to compare the overall safety and efficacy between the leadless pacemaker and left bundle area pacing.
This is a prospective, randomized controlled (1:1) multicenter trial. The pilot study will be conducted up to three clinical sites in the United States. This study is designed to compare the safety and effectiveness of two types of pacemaker treatments: leadless pacemakers and left bundle area pacing. Patients who's heart rhythm indicate a degree of heart block that slows the heart beat and decreases the amount of blood the heart is pumping to the rest of the body will be identified by physicians to participate. This study seeks to improve our understanding of heart rhythm disorders to allow us to provide the best treatment for our patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
75
NCH Healthcare
Naples, Florida, United States
RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGEfficacy & Safety
The composite of: 1. procedural success 2. freedom from serious device-related complications at one year 3. freedom from heart failure or drop in ejection fraction below 50%.
Time frame: 12 months
Procedure time
measured in minutes
Time frame: from procedure start to procedure end
Device longevity
device longevity as noted on interrogation reports
Time frame: at 12 month follow up
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