This study is a prospective, non-randomized pilot study looking to evaluate the effectiveness of Closed Loop Stimulation (CLS) in sinus node dysfunction patients with HIS bundle placement. Patients with sinus node dysfunction who have previously received a Biotronik pacemaker with His bundle lead placement as part of routine care will be recruited for the study. A hand-grip exercise will be performed at the conclusion of bicycle exercise testing in order to assess the performance of CLS during isometric exercise. After the study exercise testing is completed, data will be collected from the pacemaker.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
5
Exercise testing will be scheduled on the same day as the enrollment visit and within 30 days after post-implant visit. The standard protocol will be typically set at an initial workload of 15Watts and go up by increments of 10 Watts every 3 minutes, as follows: Stage 1 - 15 W Stage 2 - 25 W Stage 3 - 35 W Stage 4 - 45 W
New York University School of Medicine
New York, New York, United States
Change in heart rate from baseline to Day 30
Ability to achieve adequate heart rate, defined as reaching upper sensor rate, during peak exertion
Time frame: Day 1, Day 30
Greater heart response with CLS compared to predicted accelerometer based heart rate response
CLS rate response will be analyzed individually for each subject by comparing the CLS response, which is collected by the CLS Action Log, to heart rate information.
Time frame: Day 1, Day 30
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