Efficacy and Safety of Leadless Pacemakers Versus Left Bundle Area Pacing - A Preliminary Exploration

Recruiting N/A Interventional Study
Pacemaker Implantation AV Node Disease
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Other
Participants needed
75 (estimated)
Sponsor
NCH Healthcare System, Inc. dba Naples Comprehensive Health and dba NCH · Other
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Age \> 18 2. Planned for: 1. permanent pacemaker implantation for AV node disease (first, second or third degree), OR 2. post-TAVR patient requiring permanent pacemaker implantation 3. Preserved ejection fraction \> 50% 4. Preserved sinus node function 5. Willingness t…
Contacts

Dinesh Sharma, MD

(239) 624-8113

dinesh.sharma@nchmd.org

CONTACT

Kathy Byrd, RN

(239)624-8113

Kathy.Byrd@nchmd.org

CONTACT