Status:
TERMINATED
Left Bundle Area Versus Selective His Bundle Pacing
Lead Sponsor:
David Haines, MD
Conditions:
Bradycardia
Sinus Node Dysfunction
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
This is a voluntary research study to find out which location in the heart a pacemaker wire is the most efficient for a patient's heart and for battery life. Patients who volunteer and are eligible fo...
Detailed Description
This is a single center, open label, prospective randomized pilot study to evaluate the capture threshold of His Bundle versus left bundle area pacing. Secondary analysis will focus on changes in left...
Eligibility Criteria
Inclusion
- Over 18 years old.
- With signed consent.
- Pacemaker indication according to 2018 American College of Cardiology/American Heart Association/Heart Rhythm Society Guideline on the Evaluation and Management of Patients with Bradycardia and Cardiac Conduction Delay. With one or both of the following:
- Symptomatic sinus node dysfunction.
- Symptomatic Atrioventricular (AV) block or high degree AV block.
- Tachy-Brady syndrome
Exclusion
- Previously implanted cardiac pacing devices except transvenous temporary pacemaker.
- Patients who are eligible for appropriate cardiac resynchronization therapy(CRT) or implantable cardiovert defibrillator (ICD) implantation
- Patients with prior septal myectomy
- Patients with prior surgical or transcatheter aortic valve replacement
- Anatomy precluding implant evaluated during the screening or identified during the procedure.
- Those without ability to achieve selective His bundle pacing evaluated during the screening or identified during the procedure
- Pregnant women
Key Trial Info
Start Date :
October 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 22 2022
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04093414
Start Date
October 7 2019
End Date
February 22 2022
Last Update
August 17 2022
Active Locations (2)
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1
Beaumont Health System
Royal Oak, Michigan, United States, 48073
2
Beaumont Health System
Troy, Michigan, United States, 48085